Status:
TERMINATED
18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
PHASE2
Brief Summary
Background: * Positron emission tomography (PET) uses radioactive substances called radiotracers to locate areas of cancer in the body. For this test, the patient is given an injection of the radiotr...
Detailed Description
Background: * 3-deoxy-3-18F-fluorothymidine (FLT) positron emission tomography (FLT PET)/Compute tomography (CT) has been shown to correlate with the rate of cellular/tumor proliferation. * The Imagi...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Participant must be enrolled in a lymphoma therapy study at the National Institutes of Health (NIH) Clinical Center OR be enrolled in the Cancer and Leukemia Group B (CALGB) 50303 study at another site OR undergoing a new course of treatment of lymphoma at another facility.
- Participants must have a clinical course consistent with lymphoma and have available documentation of lymphoma from either the National Cancer Institute (NCI) or from an outside pathology laboratory.
- Participant must be 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) Performance score of 0 or 1.
- Ability to provide informed consent. All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.
- For subjects enrolling in early response arm
- Must be enrolled in CALGB 50303 or a lymphoma therapy study at the NIH Clinical Center or undergoing a new course of treatment of lymphoma at another facility
- Must not have begun lymphoma therapy for this tumor occurrence/ relapse
- Prior completed therapy does NOT affect eligibility
- For subjects enrolling in the residual FDG avid mass arm
- Must have a residual (18)F-fluorodeoxyglucose (FDG) positron emission tomography (PET) positive mass greater than equal to 1cm, with uptake greater than that of mediastinal blood pool.
- Participant will undergo a repeat FDG PET/CT scan if the original FDG/PET imaging performed at an outside institution is not of adequate imaging quality for subjects enrolling in the residual FDG mass arm.
- EXCLUSION CRITERIA:
- Known allergy to fluorothymidine.
- Participants for whom enrollment would significantly delay (greater than 2 weeks) the scheduled standard of care therapy.
- Participants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results are excluded.
- Participants with severe claustrophobia not relieved by oral anxiolytic medication or patients weighing greater than 136 kg (weight limit for scanner table).
- Other medical conditions deemed by the Principal Investigator (PI) or associates to make the patient ineligible for protocol procedures.
Exclusion
Key Trial Info
Start Date :
September 29 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2014
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00775268
Start Date
September 29 2008
End Date
October 23 2014
Last Update
March 11 2021
Active Locations (2)
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1
Walter Reed National Medical Center
Bethesda, Maryland, United States, 20301
2
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892