Assessing Response to Treatment in Non-Hodgkin's Lymphoma Patients Using 64Cu-DOTA-Rituximab PET/CT
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|ClinicalTrials.gov Identifier: NCT01598558|
Recruitment Status : Withdrawn (Accrual issues - Low Accrual)
First Posted : May 15, 2012
Last Update Posted : October 4, 2016
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
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
|United States, California|
|Stanford University Cancer Institute|
|Stanford, California, United States, 94305|
|Principal Investigator:||Sanjiv Gambhir, MD, PhD||Stanford University|