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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01598558
Recruitment Status : Withdrawn (Accrual issues - Low Accrual)
First Posted : May 15, 2012
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
Sanjiv Sam Gambhir, Stanford University

Study Description
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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


Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: Cu-64 Rituximab Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessing Response to Treatment in Non-Hodgkin's Lymphoma Patients Using 64Cu-DOTA-Rituximab PET/CT
Study Start Date : January 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598558


Locations
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United States, California
Stanford University Cancer Institute
Stanford, California, United States, 94305
Sponsors and Collaborators
Sanjiv Sam Gambhir
Investigators
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Principal Investigator: Sanjiv Gambhir, MD, PhD Stanford University
More Information
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Responsible Party: Sanjiv Sam Gambhir, Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT01598558    
Other Study ID Numbers: LYMIMG0002
8556 ( Other Identifier: Stanford IRB )
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents