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

Not Applicable

Withdrawn

• Conditions: Non-Hodgkin's Lymphoma
• Interventions: Drug: Cu-64 Rituximab

• Registration Number: NCT01598558
• Lead Sponsor: Sanjiv Sam Gambhir

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-10
• Study First Submitted QC: 2012-05-14
• Study First Posted: 2012-05-15
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-03
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients must have a diagnosis of CD20-positive B-cell NHL and a staging 18F FDG PET/CT prior to the 64Cu-DOTA-Rituximab PET/CT
• Patients must understand and voluntarily sign an Informed Consent form after the contents have been fully explained to them
• Patients must be scheduled for rituximab-based therapy
• Patients must be older than 18-year-old

Exclusion Criteria

• Patients who cannot complete a PET/CT scan
• Pregnant women
• Patients participating in other research protocols will be excluded from this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
64Cu-DOTA	Cu-64 Rituximab	Subjects will be injected with less than 14 mCi of 64Cu-DOTA-Rituximab. This is a slow infusion, done over 20 minutes.

Primary Outcome Measures

Name	Time	Method
Change in pre and post treatment SUV max value on the 64CU-DOTA-Rituximab PET/CT and 18F FDG PET/CT	baseline and 6 weeks	Pre- and post-treatment tumor SUVmax value on the 64Cu-DOTA-Rituximab PET/CT and 18F FDG PET/CT, and resulting EORTC-based classification of patients as responding or not responding to treatment.

Trial Locations

Locations (1)

Stanford University Cancer Institute; 🇺🇸 Stanford, California, United States