drugset / Trial / NCT01598558

Assessing Response to Treatment in Non-Hodgkin's Lymphoma Patients Using 64Cu-DOTA-Rituximab PET/CT

NCT01598558 ↗

Withdrawn Sanjiv Sam Gambhir
Non-randomizedSingle-groupOpen-labelDiagnostic

Summary

Rituximab is an antibody targeted against the CD20 antigen found primarily on B-cells. Therefore, an imaging agent targeting CD20 expression may provide a more accurate evaluation of extent of disease and response to therapy than the current standard of care, F-18 FDG PET/CT. The main purpose of the study is to investigate a new PET/CT imaging probe for detection and follow up of lymphoma. Following are the 3 aims of the study: a) Phase I testing in lymphoma patients of Cu-64 labelled Rituxan for defining normal tracer biodistribution, stability, pharmacokinetics and radiation dosimetry; b) comparison of Cu-64 Rituxan and F-18 FDG PET/CT in lymphoma patients; c) evaluation of changes in uptake of Cu-64 Rituxan in response to rituximab-based treatment in CD20-positive B-cell NHL

Timeline

Start
2012-01
Primary completion
2015-12
Completion
2015-12

Outcome

Outcome not reported

Stopped (Enrollment): “Accrual issues - Low Accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cu-64 Rituximab Monoclonal antibody 14 unknown Intravenous

Indications