Biomedical subjects

L N Tanenbaum

Publications and source records attributed to L N Tanenbaum.

5 recordsLinked to original sources

PubMed2001

A clinical comparison of the safety and efficacy of MultiHance (gadobenate dimeglumine) and Omniscan (Gadodiamide) in magnetic resonance imaging in patients with central nervous system pathology.

RATIONALE AND OBJECTIVES: The safety and diagnostic efficacy of MultiHance (gadobenate dimeglumine) in the central nervous system (CNS) were evaluated in a double-blind, multicenter, phase III clinical trial. METHODS: Two hundred five patients highly suspected of having a CNS lesion (by previous imaging exam) were enrolled at 16 sites in the United States. Patients were randomized to one of three incremental dosing regimens. Magnetic resonance imaging with Omniscan (gadodiamide) at doses of 0.1 and 0.3 mmol/kg was compared with MultiHance (gadobenate dimeglumine) at doses of 0.05 and 0.15 mmol/kg and at 0.1 and 0.2 mmol/kg. RESULTS: Compared with predose images alone, efficacy was demonstrated in each of the gadobenate dimeglumine and gadodiamide groups (single and cumulative doses) as indicated by the level of diagnostic information, number of lesions detected, and contrast-to-noise ratio measurements. The level of diagnostic information from gadobenate dimeglumine at 0.1 mmol/kg was equivalent to that with gadodiamide at the same dose. One of the two blinded reviewers found equivalence between the gadobenate dimeglumine 0.05 mmol/kg dose and gadodiamide at 0.1 mmol/kg. Both reviewers found the level of diagnostic information to be equivalent after the second dose of contrast for all three dosing regimens. The cumulative doses of gadobenate dimeglumine were well tolerated and as safe as gadodiamide. CONCLUSIONS: Gadobenate dimeglumine is comparable to gadodiamide in terms of safety and efficacy for imaging of CNS lesions, with a possible advantage in imaging applications owing to enhanced T1 relaxivity.

Brain Neoplasms↗

PubMed1999

A multisite phase III study of the safety and efficacy of a new manganese chloride-based gastrointestinal contrast agent for MRI of the abdomen and pelvis.

The purpose of this study was to evaluate the safety and efficacy of a manganese chloride-based oral magnetic resonance (MR) contrast agent during a Phase III multisite clinical trial. Two hundred seventeen patients were enrolled who were already scheduled for MRI of the abdomen and/or pelvis. In this group of patients, it was postulated that the use of an oral agent would better allow discrimination of pathology from bowel. Patients with known gastrointestinal pathology including peptic ulcer disease, inflammatory bowel disease, obstruction, or perforation were excluded to minimize confounding variables that could affect the safety assessment. Of these 217 patients, 18 received up to 900 mL of placebo, and 199 patients were given up to 900 mL of a manganese chloride-based oral contrast agent, LumenHance (Bracco Diagnostics, Inc.). Safety was determined by comparing pre- and post-dose physical examinations, vital signs, and laboratory examinations and by documenting adverse events. Efficacy was assessed by unblinded site investigators and two blinded reviewers who compared pre- and post-dose T1- and T2-weighted MRI scans of the abdomen and/or pelvis. In 111 (57%) of the 195 cases evaluated for efficacy by site investigators (unblinded readers), MRI after LumenHance provided additional diagnostic information. Increased information was found by two blinded readers in 52% and 51% of patients, respectively. In 44/195 cases (23%) unblinded readers felt the additional information would have changed patient diagnosis and in 50 patients (26%), it would have changed management and/or therapy. Potential changes in patient diagnosis or management/therapy were seen by the two blinded readers in 8-20% of patients. No clinically significant post-dose laboratory changes were seen. Forty-eight patients (24%) receiving LumenHance and four patients (22%) receiving placebo experienced one or more adverse events. Gastrointestinal tract side effects were most common, seen in 29 (15%) of LumenHance patients and in 3 (17%) of the placebo patients. LumenHance is a safe and efficacious oral gastrointestinal contrast agent for MRI of the abdomen and pelvis.

Abdomen↗

PubMed1998

Future directions in CT technology.

Progress in helical CT acquisition and processing over the last 5 years has lead to new applications and new requirements. Recent progress to meet these requirements is discussed in this article. The potential of future acquisition developments and their potential to further import application are explored.

Data Display↗

PubMed1998

Contemporary spinal CT applications.

Despite the widespread availability of MR imaging, CT remains a vital modality for the evaluation of disorders of the spine, offering superior assessment of bone abnormalities, as well as calcification. Advances in technology have enhanced the capabilities of CT, providing exciting new options for data rendering and display. Depending on the clinical indication, either CT or MR may be the modality of choice in the evaluation of spinal disease.

Calcinosis↗

PubMed1997

Disturbance of social cognition after traumatic orbitofrontal brain injury.

A patient with traumatic orbitomedial frontal lobe damage demonstrated good neurocognitive recovery but a lasting, profound disturbance of emotional regulation and social cognition. Initial neuropsychological findings included a complete anosmia, mildly reduced fluency and disturbed motor regulation. The impairments of fluency and motor regulation resolved, and formal measures of "frontal lobe" functioning were generally intact. However, she remained impaired on tasks requiring the interpretation of social situations, which mirrored her impairment in real life functioning. This disturbance in social cognition appeared related to difficulty appreciating and integrating the relatively subtle social and emotional cues required for the appropriate interpretation of events. The patient's presentation represents an intermediate position between patients with profound neurobehavioral deficits and patients with impaired real-life social cognition despite intact neuropsychological performance following orbitofrontal damage. Variations in the orbitofrontal behavioral syndrome may be related to extent of lesion, time post injury and the course of recovery in different patients.

Journal Article↗