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

This study has been withdrawn prior to enrollment.
(Accrual issues - Low Accrual)
Information provided by (Responsible Party):
Sanjiv Sam Gambhir, Stanford University Identifier:
First received: February 10, 2012
Last updated: November 16, 2015
Last verified: November 2015

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

Condition Intervention
Non-Hodgkin's Lymphoma
Drug: Cu-64 Rituximab

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessing Response to Treatment in Non-Hodgkin's Lymphoma Patients Using 64Cu-DOTA-Rituximab PET/CT

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Change in pre and post treatment SUV max value on the 64CU-DOTA-Rituximab PET/CT and 18F FDG PET/CT [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: Yes ]
    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.

Enrollment: 0
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 64Cu-DOTA
Subjects will be injected with less than 14 mCi of 64Cu-DOTA-Rituximab. This is a slow infusion, done over 20 minutes.
Drug: Cu-64 Rituximab
Up to 14 mCi, iv
Other Name: Genentech/MIPS


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01598558

United States, California
Stanford University Cancer Institute
Stanford, California, United States, 94305
Sponsors and Collaborators
Sanjiv Sam Gambhir
Principal Investigator: Sanjiv Gambhir, MD, PhD Stanford University
  More Information

No publications provided

Responsible Party: Sanjiv Sam Gambhir, Professor of Radiology, Stanford University Identifier: NCT01598558     History of Changes
Other Study ID Numbers: LYMIMG0002, 8556
Study First Received: February 10, 2012
Last Updated: November 16, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 30, 2015