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

NCT ID: NCT01598558

Last Updated: 2016-10-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-12-31

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

Conditions

Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

64Cu-DOTA

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

Group Type: EXPERIMENTAL

Cu-64 Rituximab

Intervention Type: DRUG

Up to 14 mCi, iv

Interventions

Cu-64 Rituximab

Up to 14 mCi, iv

Intervention Type: DRUG

Other Intervention Names

Genentech/MIPS

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanjiv Sam Gambhir

OTHER

Sponsor Role: lead

Responsible Party

Sanjiv Sam Gambhir

Professor of Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sanjiv Gambhir, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University Cancer Institute

Stanford, California, United States

Countries

United States

Other Identifiers

8556

Identifier Type: OTHER

Identifier Source: secondary_id

LYMIMG0002

Identifier Type: -

Identifier Source: org_study_id