Assessing Response to Treatment in Non-Hodgkin's Lymphoma Patients Using 64Cu-DOTA-Rituximab PET/CT
Primary Purpose
Non-Hodgkin's Lymphoma
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cu-64 Rituximab
Sponsored by
About this trial
This is an interventional diagnostic trial for Non-Hodgkin's Lymphoma
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
Sites / Locations
- Stanford University Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
64Cu-DOTA
Arm Description
Subjects will be injected with less than 14 mCi of 64Cu-DOTA-Rituximab. This is a slow infusion, done over 20 minutes.
Outcomes
Primary Outcome Measures
Change in pre and post treatment SUV max value on the 64CU-DOTA-Rituximab PET/CT and 18F FDG PET/CT
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01598558
Brief Title
Assessing Response to Treatment in Non-Hodgkin's Lymphoma Patients Using 64Cu-DOTA-Rituximab PET/CT
Official Title
Assessing Response to Treatment in Non-Hodgkin's Lymphoma Patients Using 64Cu-DOTA-Rituximab PET/CT
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Accrual issues - Low Accrual
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sanjiv Sam Gambhir
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
64Cu-DOTA
Arm Type
Experimental
Arm Description
Subjects will be injected with less than 14 mCi of 64Cu-DOTA-Rituximab. This is a slow infusion, done over 20 minutes.
Intervention Type
Drug
Intervention Name(s)
Cu-64 Rituximab
Other Intervention Name(s)
Genentech/MIPS
Intervention Description
Up to 14 mCi, iv
Primary Outcome Measure Information:
Title
Change in pre and post treatment SUV max value on the 64CU-DOTA-Rituximab PET/CT and 18F FDG PET/CT
Description
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.
Time Frame
baseline and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjiv Gambhir, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Cancer Institute
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Assessing Response to Treatment in Non-Hodgkin's Lymphoma Patients Using 64Cu-DOTA-Rituximab PET/CT
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