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Results for “feasibility studies”

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At least 19 recordsLinked to original sources
PubMed2026

Continuous Intravenous Lidocaine for Refractory Cancer Pain in Palliative Care: A Multicenter Feasibility Study.

ObjectivesTo assess the feasibility and tolerability of continuous low-dose intravenous lidocaine infusion in patients with opioid-refractory cancer pain receiving palliative care, and to explore its potential impact on pain outcomes in real-world clinical conditions.MethodsWe conducted a multicenter, randomized, double-blind, placebo-controlled feasibility study in palliative care units to evaluate continuous intravenous lidocaine infusion in patients with opioid-refractory cancer pain. Patients were randomized to receive lidocaine (5&#x2005;mg/kg/day, increased to 8&#x2005;mg/kg/day if pain reduction was <30% after 24&#x2005;h) or placebo for 48&#x2005;h. Pain intensity was assessed using the Numeric Pain Intensity Scale, with a clinically meaningful response defined as a&#x2009;&#x2265;30% reduction from baseline at 40&#x2005;min. Secondary outcomes included pain evolution over time, neuropathic pain, symptom burden, and tolerability.ResultsThirty-five patients were included in the final analysis (18 lidocaine, 17 placebo). No significant difference was observed between lidocaine and placebo for the primary endpoint or for secondary pain outcomes. Reductions in pain intensity were observed in both groups. In the lidocaine group, 61% of patients required dose escalation to 8&#x2005;mg/kg/day. Continuous intravenous lidocaine infusion was generally well tolerated, with mostly mild adverse events and no unexpected toxicity.ConclusionIn this multicenter feasibility study, continuous low-dose intravenous lidocaine did not demonstrate a clinically meaningful analgesic benefit over placebo. As the planned sample size was not reached, the study was underpowered. These findings highlight the challenges of randomized trials in palliative care and may inform future feasibility-oriented designs.

Humans↗
PubMed2026

Evaluation of muscle microvascular perfusion in primary mitochondrial disease by contrast-enhanced ultrasound: Feasibility study.

BACKGROUND: Primary mitochondrial disease (PMD) are genetic disorders characterized by impaired oxidative metabolism and microvascular abnormalities that contribute to the myopathy. OBJECTIVES: This study evaluates the feasibility and utility of contrast-enhanced ultrasound (CEUS) for quantifying skeletal muscle perfusion in patients with PMD. In addition, we assessed exercise-induced changes following cardiopulmonary exercise testing (CPET) to characterize dynamic vascular responses. DESIGN: Prospective pilot feasibility study. METHODS: We enrolled genetically confirmed PMD and healthy control participants with ability to complete the CPET protocol. CEUS of the vastus lateralis muscle was performed at rest and following CPET. Imaging parameters were standardized across all CEUS scans, with a fixed mechanical index of 0.13. Perfusion parameters, including perfusion index (PI), peak enhancement (PE), and area under the curve (AUC) were quantified using delta projection analysis, and compared between PMD and control participants, and within each group, pre- and post-exercise. RESULTS: A total of 5 PMD and 5 control participants were evaluated. At rest, CEUS demonstrated a trend in higher muscle perfusion in PMD as compared to control participants on comparing PI (13.7 &#xb1; 2.7 vs. 10.7 &#xb1; 3.2; p = 0.42), PE (24.9 &#xb1; 11.5 vs. 14.3 &#xb1; 6.8; p = 0.22), and AUC (95,253.4 &#xb1; 35,072.8 vs. 73,591.2 &#xb1; 32,820.6; p = 0.31), which did not reach statistical significance, likely in part due to the small cohort size. Following CPET, PMD participants demonstrated exaggerated percentage increases in PI (+21.1% vs. +16.0%), PE (+11.2% vs. +7.6%), and AUC (+20.2% vs. +12.5%) as compared to control participants. Within group analysis revealed a significant post-exercise increase in AUC among PMD participants (p = 0.01) but did not reach significance in control participants. CONCLUSION: This is the first study to demonstrate the feasibility and utility of conducting CEUS to assess skeletal muscle perfusion in ambulatory PMD patients. The distinct perfusion patterns and exaggerated exercise-induced responses observed in PMD as compared to control participants suggest that reactive hyperemia occurs in PMD at rest and is further exaggerated by exercise. CEUS may serve as a sensitive tool for detecting microvascular alterations in PMD.

cardiopulmonary exercise testing (CPET)↗
PubMed2026

Diagnostic performance of intraoperative in vivo hyperspectral imaging for meningioma grading and molecular alterations: results from a prospective feasibility study.

OBJECTIVE: Hyperspectral imaging (HSI) is an emerging intraoperative, noninvasive, contrast agent-free imaging modality that enables quantitative assessment of tissue composition. The present study aimed to investigate whether HSI-derived tissue parameters correlate with WHO grade and molecular markers of aggressiveness in cranial meningiomas. METHODS: In this prospective study, intraoperative in vivo HSI was performed using the TIVITA tissue system, capturing spectral signatures between 500 and 1000 nm. Quantitative tissue parameters included tissue oxygen saturation (StO2), near-infrared perfusion index, organ hemoglobin index (OHI), and tissue water index (TWI). HSI parameters were correlated with histopathological WHO grade and molecular alterations, including CDKN2A/B deletion, TERT promoter mutation, and 1p/22q loss. Group differences were analyzed using one-way ANOVA, and diagnostic performance was assessed using receiver operating characteristic (ROC) analysis. RESULTS: Forty-six meningiomas were included, comprising WHO grade 1 (n = 35) and WHO grade 2-3 (n = 11) tumors. TWI was significantly higher in WHO grade 2-3 meningiomas compared with WHO grade 1 tumors (mean 0.49 [SD 0.12] vs 0.38 [SD 0.17], p = 0.048). ROC analysis demonstrated an area under the ROC curve (AUC) of 0.71 (95% CI 0.56-0.86, p = 0.036) for TWI in discriminating higher-grade disease. A TWI cutoff &#x2265; 0.367 identified all WHO grade 2-3 meningiomas with 100% sensitivity and 100% negative predictive value. In a molecular subgroup (n = 15), OHI appeared higher in tumors with homozygous CDKN2A/B deletion than in nondeleted tumors (mean 0.77 [SD 0.04] vs 0.62 [SD 0.10]). However, only 3 CDKN2A/B-deleted cases were available, and these findings should be considered descriptive. ROC analysis yielded an AUC of 0.89 (95% CI 0.71-1.00). An OHI cutoff &#x2265; 0.712 identified all three CDKN2A/B-deleted tumors (100% sensitivity), with 83.3% specificity and 86.7% accuracy. CONCLUSIONS: The present investigation demonstrated that HSI-derived tissue water and hemoglobin metrics provide biologically meaningful information in meningiomas. Low tissue water content appeared to rule out higher-grade diseases in this first subset cohort, while elevated hemoglobin showed a potential association with CDKN2A/B deletion in a small exploratory subgroup. These findings support the potential of HSI as a real-time noninvasive tool for intraoperative risk stratification and should be evaluated in large-scale studies. German Clinical Trials Register no. DRKS00036771 (www.drks.de).

Humans↗
PubMed2026

Breast Cancer Recurrence Status Assessment in 5 Years Using Multimodal Integrated Learning: A Feasibility Study.

Despite advances in breast cancer detection and treatment, recurrence after curative therapy continues to impact long-term survival and quality of life. Therefore, early identification of high-risk patients is crucial to guide personalized treatment and follow-up strategies. Although genomic assays provide valuable prognostic insights, their high cost and limited accessibility hinder widespread adoption in clinical practice. Recent machine learning or deep learning approaches leveraging clinical, imaging, or multimodal data have shown promise but do not reflect real-world clinical scenarios. This study proposes a deep learning-based multimodal framework for predicting 5-year breast cancer recurrence using routinely collected clinical data. The framework consists of three main components. First, we adopted automated tumor segmentation with MedSAM to extract the tumor region from ultrasound images. The radiomics features are extracted from those tumor regions. Second, report features are extracted using a Med-Contrastive Pre-trained Transformers (MedCPT)-based approach incorporating predefined, clinically informed queries. Third, a multimodal integration model jointly processes image, radiomics, clinical features, and report features through modality-specific branches. The image branch employs the Ultrasound Foundation Model (USFM) as the backbone, while structured tabular data is processed using the FT-Transformer architecture. The features of all branches are fused using a mixture-of-experts (MoE)-based classifier, and the entire model is trained using a progressive fusion training strategy. Experimental results confirm the feasibility of using ultrasound images with tumor mask integration for recurrence prediction and demonstrate the additive value of integrating multiple data modalities through the proposed multimodal integration model. The final model for recurrence prediction achieved an AUC of 0.7540, accuracy of 74.61%, sensitivity of 70.41%, and specificity of 76.44%. This feasibility study's findings underscore the potential of the proposed multimodal deep learning framework to provide accessible, accurate, and generalizable recurrence risk prediction using routinely available clinical data, potentially supporting more informed treatment decisions and personalized post-treatment monitoring in real-world clinical practice.

Breast cancer recurrence↗
PubMedDate not supplied

A feasibility study of prompt capture gamma in vivo neutron activation analysis.

The feasibility of using the information contained in the radiative capture gamma ray spectrum of the neutron-irradiated human body to measure quantitatively total body elemental composition in vivo has been investigated. Results of time dependent Monte Carlo simulations have shown that spectral interference of nonradiative capture origin can be completely eliminated by pulsing the detector/spectrometer system in anticoincidence with the neutron source. Calculations based on the results of the Monte Carlo simulation and on an experimental measurement of the efficiency versus energy characteristics of a Ge(Li) detector suggest that the primary limitation of the proposed technique would be inter-element spectral interference rather than inadequate detector sensitivity. Experimental measurements using a pulsed 14-MeV neutron generator and Ge(Li) gamma-ray spectrometer have produced results that are consistent with the predictions of the theoretical model. A radiative capture gamma-ray spectrum of a tissue-equivalent phantom was measured in pulsed mode and analyzed offline using a computerized spectral analysis procedure. The results were scaled to a proposed facility consisting of a 2.5-MeV pulsed neutron source and a detection system comprising two 50-cm3 (Ge(Li) detectros past which the subject would be scanned. It has been shown that in principle the elements hydrogen, chlorine, calcium, and nitrogen [the latter using large NaI(T1) detectors] could be measured with such a facility at an average body dose level of 0.1 rad. At this dose level the coefficients of variation based on counting statistics alone would be +/- 2%, or better, for these four elements. With an improvement in the detector/spectrometer energy resolution, the elements sulfur and carbon might also be measurable. It is also shown that by modifying the pulsing sequence appropriately and using 14-MeV neutrons, total body oxygen could also be measured at the 0.1 rad dose level via its inelastic neutron scattering deexcitation gamma activity.

Activation Analysis↗
PubMed2026

A Phase II Feasibility Study Combining Pembrolizumab and Metformin in Patients with Metastatic Head and Neck Cancer.

PURPOSE: Survival for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) remains low with <20% immunotherapy response. Metformin increases tumor-infiltrating CD8+ T and natural killer (NK) cells, which harbor PD-1. In this phase II clinical trial (NCT04414540), we combined metformin and pembrolizumab to evaluate the overall response rate (ORR) in R/M HNSCC and assess NK-cell activity. PATIENTS AND METHODS: Eligible patients were randomized 1:1 into two arms: (i) metformin extended-release (ER) dose escalation to 2,000 mg over 14 days followed by combination with pembrolizumab 200 mg every 3 weeks or (ii) pembrolizumab 200 mg every 3 weeks followed by combination with metformin ER 2,000 mg daily. The primary endpoint was ORR per RECIST 1.1. Nineteen evaluable patients were planned to estimate the proportion of approximately 32% ORR. Safety was evaluated according to Common Terminology Criteria for Adverse Events v5.0. The distribution, activation, and cytotoxic function of NK cells were analyzed via flow cytometry. RESULTS: Twenty-one patients were enrolled; 76% were male, 52% were smokers, and the median age was 64 years. Ten patients had oropharyngeal tumors, of which nine were p16+. Eighteen patients were evaluable for response, including four complete and five partial responses for an ORR of 50% [95% confidence interval (29-71)]. Combination therapy was well tolerated with no unexpected adverse events (AE). Five grade 3 AEs occurred: nausea, diarrhea, fatigue, and weight loss. Metformin led to increased peripheral NK-cell maturation and cytotoxic ability. CONCLUSIONS: The combination of metformin and pembrolizumab was well tolerated with mild gastrointestinal AEs and promising activity, warranting further investigation in a randomized trial.

Humans↗
PubMedDate not supplied

Addition of fluoride to pit and fissure sealants--a feasibility study.

The data obtained in this in vitro study indicate that contact with pit and fissure sealants to which NaF has been added in amounts ranging from 2 to 5% substantially increases the fluoride content of the enamel and reduces its solubility in acid. The properties of the materials do not seem to be impaired by the addition of fluoride in these amounts. It thus appears that this approach to providing a backup anticariogenic mechanism may, indeed, be feasible. However, further investigation must be done to confirm the anticariogenic effect and to establish the most efficacious means of fluoride incorporation in the materials.

Acrylic Resins↗
PubMed1976

Minilaparotomy for female sterilization: a feasibility study of a new technique.

Female sterilization via a minilaparotomy incision was performed on 30 patients at Al-Azhar University Teaching Hospital in Cairo, Egypt. A uterine sound fed through a Foley catheter was used as a uterine elevator. A 2 cm suprapubic transverse laparotomy was performed and sterilization was accomplished by fimbriectomy. Twenty patients received general anesthesia and 10 patients initially received local anesthesia. Surgical time ranged from 7 to 15 min, and the average duration of hospitalization was 8 hours. Blood loss was small, and no patient was transfused. One patient had a wound infection. This pilot study indicates that this procedure is relatively simple, safe and inexpensive.

Female↗
PubMed2026

Application of PathoChip to urine-derived nucleic acids for broad microbial profiling in men with suspected prostate cancer: setup of a methodological workflow and pilot feasibility study.

BACKGROUND: Urine-based liquid biopsy is an attractive non-invasive source of prostate cancer (PCa) biomarkers, but urinary microbiome studies have mainly relied on 16S rRNA sequencing or shotgun metagenomics. This pilot study optimized and evaluated a practical workflow using PathoChip - a broad-spectrum microarray designed to detect bacterial, viral, fungal, and parasitic signatures - for microbial profiling of urine sediments from men with suspected PCa, an application not previously established. METHODS: First-morning urine was collected without prostatic massage from 35 men scheduled for biopsy; 19 were diagnosed with PCa and 16 were biopsy-negative. Different urine volumes and extraction strategies were evaluated to optimize DNA/RNA recovery. A setup phase compared 25&#x202f;ng versus 50&#x202f;ng of urine DNA and RNA input. DNA/RNA isolated from human B cells was used as reference control. An analysis pipeline was developed to detect outlier probes and create a presence/absence matrix. Reproducibility was assessed via library yield, Pearson correlation, blank-control subtraction, outlier probe detection. Prevalence comparisons were performed between clinical groups. RESULTS: An 8&#x202f;mL starting volume was chosen as consistently available from self-collected urine. Sequential DNA/RNA extraction using the AllPrep DNA/RNA Micro Kit from sediment provided the best balance between nucleic-acid recovery, purity, and clinical compatibility. Reducing the input from 50&#x202f;ng to 25&#x202f;ng preserved highly concordant hybridization profiles, with matched samples clustering together with strong correlations. Exploratory analysis revealed PCa- and grade-associated patterns involving Actinomycetaceae, Aerococcaceae, and Streptococcaceae, with Streptococcaceae enriched in PCa of higher grades (ISUP GG&#x202f;&#x2265;&#x202f;2). Other signatures, including Mobiluncus, Prevotella, Rhodotorula, Hymenolepis, and JC polyomavirus, were broadly detected but not PCa-discriminating. CONCLUSIONS: PathoChip can be adapted to urine sediments, generating reproducible microbial profiles from limited DNA/RNA input without prostatic massage. This platform provides a quick and accessible approach to broad screening, extending beyond 16S rRNA sequencing by enabling simultaneous multi-kingdom detection. The observed PCa- and grade-associated patterns are hypothesis-generating and require validation in larger independent cohorts.

Pathochip↗
PubMed1978

Passive immunization with an antibody to the beta-subunit of ovine luteinizing hormone as a method of early abortion--a feasibility study in monkeys (Macaca radiata).

Antiserum to the beta-subunit of ovine luteinizing hormone (oLH-beta) raised in monkeys (Macaca radiata) has been tested by a variety of criteria both in vivo and in vitro to establish its ability to neutralize oLH, hLH, and human chorionic gonadotropin (hCG). Passive administration of this antiserum caused inhibition of ovulation and termination of pregnancy in recipient monkeys as indicated by premature vaginal bleeding and a significant reduction in serum progesterone and estrogen levels. The results suggest that antiserum raised in monkeys against oLH-beta can neutralize monkey LH as well as monkey CG.

Abortion, Induced↗
PubMed2026

Carrot Juice Intake Modulates Oncogenic and Inflammatory Pathways in Advanced Colorectal Adenomas: A Pilot Feasibility Study.

Carrots are a rich dietary source of carotenoids and polyacetylenes, bioactive compounds with demonstrated anti-inflammatory and anticancer properties in experimental models. Epidemiological evidence suggests that carrot consumption is associated with a reduced risk of colorectal cancer; however, clinical data linking carrot intake to molecular changes in premalignant colorectal tissue remain limited. In this pilot intervention study, 20 patients with advanced colorectal adenomas were enrolled. Fifteen participants consumed carrot juice daily for 21&#x2009;days, while five served as untreated controls. Paired adenoma biopsies were collected before and after the intervention and were analyzed using gene expression microarrays to assess transcriptional responses. Carrot juice intake was well tolerated, with adherence exceeding 95% and no reported adverse events. Transcriptomic analysis revealed modulation of key pathways implicated in colorectal carcinogenesis, including downregulation of the WNT, PI3K-AKT, and MAPK signaling pathways, as well as cyclooxygenase-2-related inflammatory pathways and cytokine signaling. These changes were consistent with reduced oncogenic signaling and attenuation of inflammatory activity within adenoma tissue. In summary, short-term carrot juice consumption was associated with coordinated suppression of molecular pathways involved in colorectal adenoma progression. These findings provide preliminary clinical evidence that a whole-food dietary intervention may influence early carcinogenic processes and support the need for larger controlled studies evaluating clinical outcomes.

Journal Article↗
PubMed1976

Dietary and drug treatment of hyperlipidaemia. A feasibility study in asymptomatic middle-aged men.

83 middle-aged men with different types of hyperlipoproteinaemia were recruited from a health examination survey. They were treated with diet for 3 months and with diet and drugs in combination over a 2-year period (63 men used drugs). The serum lipid reductions after the dietary period were 14% and 27% for serum cholesterol and triglycerides, respectively. After 2 years the corresponding reductions were 21% and 42%, indicating an additional effect of diet and drugs. There was an average body weight reduction of 4.3% during the first 3 months which was maintained over the 2-year period. Special considerations in treating asymptomatic individuals are discussed.

Body Weight↗
PubMed1979

High-fibre foods: a feasibility study using guar gum.

Guar gum at different concentrations was incorporated into foods from six groups to establish some principles to aid the production of high-viscosity therapeutic foods. The amounts of gum that could be incorporated into a food, without major loss of acceptability, were higher in products with low final water content than those with high final water content. The domestic preparation of these recipes should be possible provided that recipe modifications are carefully followed.

Cellulose↗