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

Sanjiv Sam Gambhir

Status: Withdrawn

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: Cu-64 Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT01598558

8556 (Other Identifier)

LYMIMG0002

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

64Cu-DOTA

Experimental group

Description:

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

Treatment:

Drug: Cu-64 Rituximab