Status:
COMPLETED
FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Lymphoma
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
Brief Summary
A research study of a new method of visualizing internal organs called 18F-FLT PET/CT that yields better tracking of cancer treatment progress. PET/CT stands for positron emission tomography with low ...
Detailed Description
-Primary Objective Investigate whether the PPV of FLT-PET/CT is significantly higher than that of FDG-PET/CT by following up patients for at least 24 months post-therapy or until evidence of persiste...
Eligibility Criteria
Inclusion
- All patients must have a histologic or cytological diagnosis of de novo DLBCL and be scheduled to receive first line chemotherapy with R-CHOP given every 21 days (R-CHOP-21) within 6 weeks of their enrollment and for 6 cycles.
- Patients must be \>=18 years of age, but there will be no discrimination based on gender, race, creed, or ethnic background.
- Patients must have an ECOG performance status of 0-2.
- Patients must sign an informed consent, and be mentally responsible.
Exclusion
- Subjects with significant concurrent medical complications that in the judgment of the Principal Investigator(s) could affect the patient's ability to complete the planned trial, including the multiple imaging studies.
- Patients with history of prior lymphoma (e.g., follicular lymphoma) and/or second cancers other than basal cell carcinoma.
- Patients planned to be treated with R-CHOP-14 (i.e., R-CHOP given every 14 days) will be excluded (this should be extremely rare, if at all, since R-CHOP-21 is the standard treatment.
- Patients who are scheduled to receive Rituxan or any other therapy (e.g., XRT, radioimmunotherapy) as adjuvant therapy after completion of R-CHOP-21.
- Pregnant women will be excluded.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) after study entry and for the duration of study participation. The effects of FLT on the developing human fetus are unknown. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A screening urine human chorionic gonadtropin (hCG) (pregnancy test) will be administered in Nuclear Medicine to women of childbearing potential before each FLT scan and pregnant women will be stopped from participating further in this study.
Key Trial Info
Start Date :
September 7 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 4 2019
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01410630
Start Date
September 7 2017
End Date
October 4 2019
Last Update
May 11 2021
Active Locations (4)
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1
University of California at Los Angeles
Los Angeles, California, United States, 90024
2
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
3
MD Anderson Cancer Center - University of Texas
Houston, Texas, United States, 77030
4
Aachen University
Aachen, Germany