Biomedical subjects

Darius Francescatti

Publications and source records attributed to Darius Francescatti.

11 recordsLinked to original sources

PubMed2006

Prospective randomized study comparing cryo-assisted and needle-wire localization of ultrasound-visible breast tumors.

BACKGROUND: This study compared the surgical results of 2 localization methods-cryo-assisted localization (CAL) and needle-wire localization (NWL)-in patients undergoing breast lumpectomy for breast cancer. METHODS: A total of 310 patients were treated in an institutional review board-approved study with 18 surgeons at 17 sites. Patients were randomized 2:1 to undergo either intraoperative CAL or NWL. A cryoprobe was inserted under ultrasound guidance in the operating room and an ice ball created an 8- to 10-mm margin around the lesion. The palpable ice ball then was dissected. NWL was placed according to institutional practice and resection was performed in a standard fashion. Surgical margins, complications, re-excisions, tissue volume, procedure times, ease of localization, specimen quality, and patient satisfaction were evaluated. Positive margins were defined as any type of disease present 1 mm or less from any specimen edge. RESULTS: Positive margin status did not differ between the 2 groups (28% vs. 31%). The volume of tissue removed was significantly less in the CAL group (49 vs. 66 mL, P = .002). Re-excisions were similar in both groups. CAL was superior in ease of lumpectomy, quality of specimen, acute surgical cosmesis, short-term cosmesis, patient satisfaction, and overall procedure time for the patient. CAL had a lower invasive positive margin rate (11% vs. 20%, P = .039) but a higher observed ductal carcinoma in situ-positive margin rate (30% vs. 18%, approaching statistical significance, P = .052). CONCLUSIONS: CAL is a preferred alternative to standard wire localization because it provides a palpable template, removes less tissue and improves cosmesis, decreases overall procedure time, and is more convenient for the patient and surgeon.

Breast Neoplasms↗

PubMed2005

Surface optimization technique for MammoSite breast brachytherapy applicator.

PURPOSE: We present a technique to optimize the dwell times and positions of a high-dose-rate (192)Ir source using the MammoSite breast brachytherapy applicator. The surface optimization method used multiple dwell positions and optimization points to conform the 100% isodose line to the surface of the planning target volume (PTV). METHODS AND MATERIALS: The study population consisted of 20 patients treated using the MammoSite device between October 2002 and February 2004. Treatment was delivered in 10 fractions of 3.4 Gy/fraction, twice daily, with a minimum of 6 h between fractions. The treatment of each patient was planned using three optimization techniques. The dosimetric characteristics of the single-point, six-point, and surface optimization techniques were compared. RESULTS: The surface optimization technique increased the PTV coverage compared with the single- and six-point methods (mean percentage of PTV receiving 100% of the prescription dose was 94%, 85%, and 91%, respectively). The surface method, single-point, and six-point method had a mean dose homogeneity index of 0.62, 0.68, and 0.63 and a mean full width at half maximum value of 189, 190, and 192 cGy/fraction, respectively. CONCLUSION: The surface technique provided greater coverage of the PTV than did the single- and six-point methods. Using the FWHM method, the surface, single-, and six-point techniques resulted in equivalent dose homogeneity.

Brachytherapy↗

PubMed2004

Treatment volume and dose optimization of MammoSite breast brachytherapy applicator.

PURPOSE: Limited information has been reported on the dosimetry achieved with the MammoSite breast brachytherapy applicator. We present our results regarding the volume of treatment and a comparison of a single prescription point, single dwell position optimization technique with a six prescription point, multiple dwell position method. METHODS AND MATERIALS: Between October 14, 2002 and February 28, 2003, 21 patients with early-stage breast cancer were treated using the MammoSite device. The treatment was delivered in 10 fractions of 3.4 Gy/fraction, b.i.d., with a minimum of 6 hours between the daily fractions. CT of the lumpectomy cavity was obtained both with and without the inflated balloon. A planning target volume was constructed using a three-dimensional planning system. A three-dimensional expansion of the balloon surface was performed using the chest wall and skin as limiting structures. The volume of the inflated balloon was removed from this volume, and the volume of tissue treated in each patient was determined. A sequential expansion in 1-mm increments around the empty lumpectomy cavity was performed until the closest equivalent volume to the planning target volume was obtained. The treatment for the patients in this study was planned using both a single prescription point, single dwell position optimization technique and a six-prescription point, multiple dwell position technique. The single prescription point method has been described in a previous publication. The six-prescription point method used six points placed 1 cm from the balloon surface. Four points are in a plane transverse to the balloon axis perpendicular to the axis of the catheter, and two points are placed along the axis of the catheter. The prescription points along the catheter axis are used to compensate for the decreased dose coverage owing to anisotropy dose distribution of the source. The Nucletron HDR Plato Brachytherapy planning system was used to optimize the source positions and dwell times. RESULTS: The volume of breast tissue treated by the MammoSite device was equal to the volume encompassed by a mean 1.6-cm (SD, 0.1) margin around the empty lumpectomy cavity. Compared with the single prescription point optimization method, the six prescription point method provided better dose coverage, with a mean percentage of volume receiving 90% of the prescription dose of 97.2% (SD = 2.1) vs. 89.5% (SD = 4.6) for the single-point method. The mean percentage of volume receiving 100% of the prescription dose was 88.9% (SD = 3.3) for the six-point method vs. 77.6% (SD = 6.1) for the single-point method. However, compared with the single-point method, the six-point optimization method resulted in treatment that was less uniform, with a mean dose homogeneity index of 0.62 (SD =.07) vs. 0.66 (SD =.08) for the single-point method. CONCLUSION: The volume of normal breast tissue treated by the MammoSite device is comparable to other methods of interstitial brachytherapy that treat a 1-2-cm margin of tissue around the excision cavity. The six-prescription point, multiple dwell position method improved dose coverage with a slight decrease in dose homogeneity. The six-point method offers greater reliability of dose coverage compared with the single-point method by providing an increased number of reference points.

Adult↗

PubMed2004

Cryoablation treatment of benign breast lesions with 12-month follow-up.

OBJECTIVE: Eighty percent of all breast biopsies reveal benign findings. The most common benign tumor is a fibroadenoma. Despite their benign nature, many women eventually choose to have their bothersome lumps surgically removed. We report the use of cryoablation to treat these benign breast lesions with minimum 12-month follow-up. METHODS: After receiving Institutional Review Board approval, a prospective nonrandomized trial was initiated in June 2000. Ultrasound-guided cryoablation of core biopsy-proven benign fibroadenomas, other benign breast nodules, or nodular fibrocystic change was performed on 78 lesions in 63 patients. Eighty-five percent of lesions treated were benign fibroadenomas. The cryoablation procedure consisted of a double freeze-thaw cycle that lasted between 6 and 30 minutes and was performed most often in an office setting. Each patient was serially evaluated for treatment efficacy, complications, and patient satisfaction. RESULTS: Sixty-four of 78 lesions (mean size 2.0 cm [range 0.8 to 4.2]) were followed-up for at least 12 months after cryoablation per protocol, which included 53 fibroadenomas. At 1 year, ultrasound tumor volume resorption was 88.3% overall (87.3% for fibroadenomas), and 73% of the entire group became nonpalpable to both clinician and patient (75% for fibroadenomas). Two of the fibroadenoma patients had their palpable residual nodule excised, both revealing necrotic debris and no viable tumor in the treated volume. Serial mammograms showed resorption of the lesion leaving minimal residual density without calcifications. Cosmesis was excellent with only a small scar remaining at the probe insertion site. There was no report of visual or palpable volumetric deficit. Patient satisfaction was good to excellent in 92% of cases. CONCLUSIONS: Cryoablation was successful in treating core biopsy-proven benign breast lesions in 63 patients. At 12 months, we found gradual resorption of treated tissue with no cosmetic deficit. Ultrasound-guided cryoablation is an effective and safe treatment for benign breast lesions, as seen at 12-month follow-up, and offers an office-based, minimally invasive alternative to surgical excision.

Adolescent↗

PubMed2004

Office-based breast ductoscopy for diagnosis.

OBJECTIVE: Ductoscopy is an evolving technology that has been used primarily and historically in conjunction with open surgical procedures. New technical improvements allow intraductal biopsy and therefore its application in the clinical setting for diagnostic evaluations of the breast. This study looks at the initial use of intraductal biopsy in a variety of settings from an academic university practice to a private single-surgeon office. METHODS: This is a multicenter retrospective series of 88 patients undergoing ductoscopy of > or =1 duct for the diagnostic workup of common breast problems. The procedures were done with the patient under local anesthesia, and intraductal biopsy specimens were taken and analyzed as breast cytology samples. RESULTS: Of the 88 patients undergoing office ductoscopy, nipple discharge was the most common indication (n = 83 patients; 94% to 66% spontaneous and 34% elicited). Fifty-five percent were high risk for breast cancer by history. The majority of patients had normal previous mammograms: 48 Breast Imaging-Reporting and Data System (BIRADS) 1, 24 BIRADS 2, and 7 BIRADS 3 to 5. The most common finding was papilloma present in 29 (32%) patients by endoscopy. Only 31% of patients had a history of brown or bloody nipple discharge. A wide variety of other endoscopic abnormalities were seen and biopsied. The average number of biopsies per patient was 2 with 18 (20.5%) having severe or malignant atypia. Further follow-up and management of these more concerning abnormalities is currently ongoing. CONCLUSIONS: These results indicate that office ductoscopy with biopsy is both feasible and does identify suspicious or malignant atypia in patients with expressed or spontaneous nipple fluid.

Adult↗

PubMed2004

Office-based cryoablation of breast fibroadenomas: 12-month followup.

BACKGROUND: Fibroadenomas comprise between 30% and 50% of all breast biopsies. Despite their benign nature, many women have their fibroadenomas surgically removed. We previously reported on a minimally invasive therapy using cryoablation to treat fibroadenomas. We now report on 12-month followup using this technique. STUDY DESIGN: A prospective, nonrandomized trial was initiated in June 2000 with IRB approval. The Visica Treatment System was used to cryoablate 70 biopsy-proved fibroadenomas in 57 patients using a freeze-thaw-freeze cycle lasting 6 to 30 minutes. Each patient was serially evaluated for safety, efficacy, and satisfaction. RESULTS: Fifty-seven fibroadenomas (mean 2.1 cm, range 0.8 to 4.2 cm) in 47 patients were followed for 12 months. At 1 year, with 89% median tumor volume reduction measured by ultrasonography, 75% of fibroadenomas were nonpalpable. There were no adverse events and only minor complications. Two patients (4%) had their lesions excised after 12 months; pathology revealed no viable fibroadenoma. Serial mammograms showed resorption of the fibroadenoma leaving minimal residual density without calcifications. Cosmesis was excellent with no volume deficit, as no tissue is removed. Ninety-one percent of patients were satisfied at 12 months. CONCLUSIONS: Cryoablation is safe and effective in treating breast fibroadenomas. It offers a nonsurgical, office-based treatment that is well tolerated by patients and accurately monitored with ultrasonographic guidance. At 12 months we found progressive tumor volume reduction and reduced palpability, with no volume deficit, excellent cosmesis, and satisfied patients. Ultrasonography-guided cryoablation is a preferred option for treatment of breast fibroadenomas without open surgery.

Adult↗

PubMed2003

Assessment of Her-2/Neu status by immunohistochemistry and fluorescence in situ hybridization in mammary Paget disease and underlying carcinoma.

HER-2/Neu overexpression is seen in 20% to 30% of invasive breast carcinomas and has been reported in as many as 80% of high-grade infiltrating carcinomas. Earlier studies have suggested that 100% of the tumor cells in mammary Paget disease show overexpression of HER-2 protein. We undertook this study to assess HER-2 status of mammary Paget disease and of the underlying breast carcinoma, when present, by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). Formalin-fixed, paraffin-embedded tissue from 20 cases of mammary Paget disease were analyzed for HER-2 status by IHC and FISH. IHC for estrogen receptor (ER) was also performed. The patients ranged in age from 34 to 88 years, with a mean age of 62 years. Eighty percent of the cases showed strong overexpression (3+) of HER-2 protein by IHC, and all of these cases showed more than 5-fold amplification of the HER-2 gene by FISH. The remaining 4 cases, which were negative for HER-2/Neu by IHC, showed no amplification by FISH. All of the latter cases expressed ER, whereas no case that overexpressed HER-2 expressed ER. Sixteen cases had an underlying tumor, which was in situ in 6 cases. The underlying tumors were identical to the Paget disease with respect to their HER-2/Neu overexpression by both IHC and FISH. HER-2 overexpression was identified in 80% of our cases of Paget disease. There was 100% concordance between HER-2 protein overexpression by immunohistochemistry and gene amplification in both the Paget and the underlying tumor. Moreover, all of the cases negative for HER-2 overexpression expressed ER, whereas those positive for HER-2 did not.

Adult↗

PubMed2002

Office-based ultrasound-guided cryoablation of breast fibroadenomas.

BACKGROUND: Fibroadenomas commonly found by palpation and routine mammography account for approximately 20% of open surgical breast biopsies. Alternatives to open surgery include tumor removal using an automated coring device and tumor ablation using heating or cooling elements. We report our initial experience with cryoablation of biopsy-proven benign fibroadenomas. METHODS: A table-top cryoablation system employing a 2.4-mm cryoprobe was used to treat biopsy-proven benign fibroadenomas up to 4 cm in maximum diameter in a prospective nonrandomized fashion. The cryoprobe was placed under ultrasound guidance. Using a treatment algorithm based on fibroadenoma size, all tumors were subjected to two freeze cycles with an interposing thaw. Skin appearance and temperature, probe temperature, iceball size, and patient comfort were closely monitored during the procedure. Follow-up examinations including ultrasonography and photographs were scheduled for up to 12 months postablation. RESULTS: Fifty patients with 57 core biopsy-proven benign fibroadenomas were treated. Seven early cases were treated in an ambulatory surgery center setting. The remaining procedures were completely office-based using only local anesthetic. Tumor diameter varied from 7 mm to 42 mm (mean 21 mm). The iceball engulfed the target lesion in each case. Transient postoperative side effects were local swelling and ecchymosis. Postoperative discomfort rarely required medication beyond acetaminophen or ibuprofen. Lesions showed progressive shrinkage and disappearance over 3 to 12 months. No skin injury was noted and appearance remained excellent. Patient satisfaction was excellent. CONCLUSIONS: With office-based use of ultrasound-guided cryoablation for fibroadenomas there was little or no pain, target lesions were reduced in size or eliminated, scarring was minimal, cosmesis outstanding, and patient satisfaction was excellent. Cryoablation offers a useful office-based alternative to surgical excision of benign fibroadenomas.

Adolescent↗

PubMed2002

Fine-needle aspiration of clinically suspicious palpable breast masses with histopathologic correlation.

BACKGROUND: The purpose of this study was to compare the diagnostic accuracy of fine-needle aspiration (FNA) of clinically suspicious palpable breast masses in women younger and older than 40 years of age. METHODS: All women who had FNA biopsy with subsequent tissue biopsy were included. The cytologic diagnoses were classified into three groups: malignant, suspicious, or benign. Histopathologic correlation was based on either a needle core biopsy, an excisional biopsy, or a mastectomy specimen. RESULTS: A total of 1,158 fine-needle aspirations performed between 1982 and 2000, on women being evaluated for a clinically palpable breast mass were included in the study. The patients were divided into two groups: group I consisted of 231 patients aged 40 years and younger, and group II consisted of 927 patients aged 41 years and older. In group I there were 117 (51%) malignant FNA diagnoses, and only 1 (1%) false-positive case, subsequently diagnosed on histopathologic material as an atypical papillomatosis. There were 20 (9%) cases diagnosed as suspicious on FNA. On histopathology 10 were malignant, and 10 were benign. Of the 91 (39%) cases interpreted as benign, only 1 (1%) was a false negative. In group II, which comprised 927 patients, there were 693 (74%) malignant FNA diagnoses, and 3 (less than 1%) false-positive cases, which on follow-up histopathologic examination revealed 2 atypical ductal hyperplasias and 1 atypical papilloma. There were 90 (10%) cases diagnosed as suspicious on FNA. On histopathology, 68 were malignant and 22 were benign. Of the 131 (14%) lesions interpreted as benign, there were 18 false-negative cases (14%), which included 17 infiltrating carcinomas and 1 ductal carcinoma in-situ. Twelve (1%) of the cases were inadequate for the study. CONCLUSIONS: The sensitivity, specificity, and positive predictive values were remarkably high and comparable in both groups: group I had 99% sensitivity, 99% positive predictive value, 99% specificity, and 99% negative predictive value; and group II had 98% sensitivity, 97% specificity, 99% positive predictive value, and 86% negative predictive value. The overall rate of false-positive (less than 1%) and false-negative cases (9%) is comparable with published literature. Suspicious cases should be further evaluated, as our study revealed more than 50% to be malignant. The incidence of malignancy in patients presenting with a clinically palpable breast mass with follow-up biopsy was 51% in patients aged 40 years and younger and 74% in patients aged 41 years and older. Fine-needle aspiration is an excellent diagnostic tool in assessing clinically palpable breast masses.

Adult↗

PubMedDate not supplied

Cosmetic outcome and incidence of infection with the MammoSite breast brachytherapy applicator.

We present our results regarding the cosmetic outcome achieved and the rate of infection using the MammoSite breast brachytherapy applicator to treat patients with partial breast irradiation. In addition, factors associated with cosmetic outcome and infection are analyzed. The study population consisted of 30 patients with early stage breast cancer treated using the MammoSite device from October 28, 2002, to February 13, 2004. Cosmetic outcome was analyzed for its association with the following parameters: volume of the balloon, balloon-to-skin distance, maximal skin point dose per fraction, V100 (percent of volume that received 100% of the prescription dose), V150 (percent of volume that received 150% of the prescription dose), and V200 (percent of volume that received 200% of the prescription dose). The occurrence of infection at the time of treatment and during follow-up was also recorded. At a median follow-up of 13 months (range 1-16 months), 53.3% of the patients (16/30) were reported to have an excellent cosmetic outcome and 40.0% (12/30) had a good cosmetic outcome. Excellent cosmetic outcome was associated with a greater mean balloon-to-skin distance compared to those who achieved a good cosmetic outcome (1.5 cm versus 1.2 cm) (p = 0.164). The mean V100, V150, and V200 of those in the excellent cosmetic outcome group were 92.1%, 34.5%, and 7.6% versus 93.0%, 34.7%, and 7.6% in the good cosmetic outcome group (p = 0.642, 0.926, and 0.853), The mean balloon volumes were 47.7 cm3 and 56.9 cm3, respectively (p = 0.063) in the excellent and good outcome groups. The mean maximal skin doses per fraction in the excellent and good outcome groups were 354.8 cGy and 422.3 cGy (p = 0.286), respectively. Infection occurred in 13.3% of the patients (4/30). An excellent or good cosmetic outcome was achieved in 93.3% of patients and infection occurred in 13.3% of patients treated with the MammoSite breast brachytherapy applicator. Excellent cosmetic outcome was associated with a greater balloon-to-skin distance, lower maximal skin dose per fraction, and smaller mean balloon volume; however, the results did not reach statistical significance.

Adult↗

PubMedDate not supplied

Office-based cryoablation of breast fibroadenomas with long-term follow-up.

Approximately 10% of women will experience a breast fibroadenoma in their lifetime. Cryoablation is a new treatment that combines the better attributes of the current standards: surveillance and surgery. It is a minimally invasive office-based procedure that is administered without the use of general anesthesia, involving minimal patient discomfort and little to no scarring. This work aimed to establish the long-term (2-3 years) efficacy, safety, and satisfaction of the procedure, as well as the impact of cryoablation on mammogram and ultrasound images. Thirty-seven treated fibroadenomas were available for assessment with an average follow-up period of 2.6 years. Of the original 84% that were palpable prior to treatment, only 16% remained palpable to the patient as of this writing. Of those fibroadenomas that were initially < or = 2.0 cm in size, only 6% remained palpable. A median volume reduction of 99% was observed with ultrasound. Ninety-seven percent of patients and 100% of physicians were satisfied with the long-term treatment results. Mammograms and ultrasounds showed cryoablation produced no artifact that would adversely affect interpretation. Cryoablation for breast fibroadenomas has previously been reported as safe and effective both acutely and at the 1-year follow-up mark, and thus has been implemented as a treatment option. At long-term follow-up, cryoablation as a primary therapy for breast fibroadenomas demonstrates progressive resolution of the treated area, durable safety, and excellent patient and physician satisfaction. The treatment is performed in an office setting rather than an operating room, resulting in a cost-effective and patient-friendly procedure. Cryoablation should be considered a preferred option for those patients desiring definitive therapy for their fibroadenomas without surgical intervention.

Adolescent↗