FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma

Trial ID or NCT#

NCT01410630

Status

not recruiting iconNOT RECRUITING

Purpose

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 dose computed tomography and has been used for many years. 18F-FLT PET/CT uses a new tracer, fluorothymidine, which is taken up by cells that are actively proliferating or dividing such as cancer cells. We hope to learn whether this tracer is superior to the conventional tracer for monitoring treatment of diffuse large B-cell lymphoma (DLBCL).

Official Title

FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma

Eligibility Criteria

Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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 Criteria:
  1. - 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.

Investigator(s)

Ranjana Advani
Ranjana Advani
Lymphoma specialist, Hematologist-Oncologist
Saul A. Rosenberg, MD, Professor of Lymphoma
Sanjiv Sam Gambhir, MD, PhD

Contact us to find out if this trial is right for you.

Contact

Krithika Rupnarayan
650-736-0959