18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma
- Positron emission tomography (PET) uses radioactive substances called tracers to locate areas of cancer in the body. For this test, the patient is given an injection of tracer and lies in a large donut-shaped scanner that detects where in the body the radioactivity accumulates. Computed tomography (CT) scans use low dose x-rays that help to better localize where the radioactive tracer is concentrating. PET/CT scans are usually done in lymphoma patients before treatment starts and at the end of treatment to evaluate the response to therapy.
- PET scans typically use a sugar-like radioactive tracer called fluorodeoxyglucose (FDG) and low-dose x-rays. Sometimes, however, FDG PET scans show what looks like active disease and presence of a mass after chemotherapy even when there are no live cancer cells. Doctors have particular problems in evaluating response to treatment when this happens because they can't tell if the mass is active cancer or just dead tumor cells.
- An experimental tracer called 18F- fluorothymidine (FLT) has high uptake in active tumor cells and may be better able to evaluate treatment response.
- To test the use of FLT PET/CT imaging in assessing treatment response in patients with lymphoma.
- Patients 18 years of age or older who are enrolled in a lymphoma therapy study at the NIH Clinical Center or in the CALGB 50330 study at another location.
- There are two arms in this study:
- The first arm evaluates FLT as an early predictor of tumor response to therapy. Patients are imaged with FLT and FDG PET before starting treatment, following two cycles of therapy and after treatment ends.
- The second arm evaluates the ability of FLT to distinguish if a mass that remains after treatment is active cancer or dead tissue. Patients who have completed treatment and in whom FDG PET shows a remaining tumor mass are imaged with FLT PET. Following the scan, the tumor is biopsied for verification.
Radiation: Fluordeoxyglucose F 18
Other: [3'-deoxy-3'-[F-18] fluorothymidine
Procedure: computed tomography
Procedure: fine-needle aspiration
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Pilot Study of 18F Fluorothymidine (FLT) PET/CT in Lymphoma|
- Diagnostic accuracy of 3'-deoxy-3'-[18F] fluorothymidine (FLT PET/CT scans as an early indicator of complete response to therapy. [ Designated as safety issue: No ]
- Diagnostic accuracy of FLT PET/CT scans in the evaluation of residual masses after therapy. [ Designated as safety issue: No ]
- Comparison of the diagnostic accuracy of FLT and fludeoxyglucose F 18 (FDG) PET/CT scans as indicators of tumor response to therapy [ Designated as safety issue: No ]
- Evaluation of whether FLT tumor uptake either prior to therapy and/or after completion of therapy are independent predictors of complete response to therapy [ Designated as safety issue: No ]
- Evaluation of whether FLT tumor uptake either prior to therapy and/or after completion of therapy are independent predictors of progression-free survival [ Designated as safety issue: No ]
- Evaluation of whether there is a significant difference in tumor, selected normal organs, and mediastinal blood pool FDG standardized uptake values (SUV) at 1- and 2-hours post-injection [ Designated as safety issue: No ]
- Evaluation of whether there is a significant difference in tumor, selected normal organs, and mediastinal blood pool FLT dynamic influx parameter (Ki) SUV at 1- and 2-hours post-injection [ Designated as safety issue: No ]
- Diagnostic accuracy of percent change in SUV between pre-treatment and mid-treatment FLT PET/CT as an indicator of complete response to therapy [ Designated as safety issue: No ]
- Diagnostic accuracy of percent change in SUV between pre-treatment and mid-treatment FLT PET/CT as an indicator of progression-free survival [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Group A
Patients undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fludeoxyglucose F 18 (FDG) PET/CT scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B.
Radiation: Fluordeoxyglucose F 18
Undergo scansOther: [3'-deoxy-3'-[F-18] fluorothymidine
Undergo scansProcedure: computed tomography
Experimental: Group B
Patients undergo an FLT PET/CT scan within 2 weeks after completion of chemotherapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated.
Biopsy takenOther: [3'-deoxy-3'-[F-18] fluorothymidine
Undergo scansProcedure: computed tomography
Undergo scansProcedure: fine-needle aspiration
- FLT PET/CT has been shown to correlate with the rate of cellular/tumor proliferation.
- The Imaging Subcommittee of the International Harmonization Project in Lymphoma recommends performing FDG PET at least 3 weeks, and preferably 6-8 weeks after chemotherapy or chemoimmunotherapy therapy and 8- 12 weeks after radiation or chemoradiation therapy due to high FDG accumulation in inflammatory tissues.
- FLT uptake in inflammatory lesions is less prominent than FDG and it is likely that FLT PET/CT can better differentiate inflammation from tumor.
- FLT PET/CT imaging is expected to better differentiate between treatment induced inflammation and malignancy and should enable early prediction of therapeutic response.
- FLT PET/CT imaging is expected to differentiate between residual inflammatory residual masses from residual malignancy and therefore guide appropriate treatment.
- To estimate the diagnostic accuracy of FLT PET/CT as an early indicator of complete response to therapy in B and T cell lymphoma.
- To estimate the diagnostic accuracy of FLT PET/CT in the evaluation of residual masses after therapy.
- Participant must be enrolled in a lymphoma therapy study at the NIH Clinical Center OR be enrolled in the CALGB 50303 study at another site OR undergoing a new course of treatment of lymphoma at another facility. The NCI Laboratory of Pathology will confirm diagnosis for subjects enrolled at all CALGB study sites.
- Participants must have a clinical course consistent with lymphoma and have available documentation of lymphoma from either the NCI or from an outside pathology laboratory.
- Subjects enrolling in the early response arm must undergo baseline FLT PET prior to receiving a new course of lymphoma therapy.
- Subjects enrolling in the residual mass evaluation arm can be enrolled at the time the FDG avid residual mass is discovered (i.e. no pre-therapy FLT image is required).
- Subjects can enroll in both arms of the study.
- Participant must be 18 years or older.
- ECOG Performance score of 0 or 1.
- SGOT, SGPT less than 5 times ULN.
- bilirubin less than or equal to 2 times ULN.
There are 2 arms in this study
- The first arm will assess of FLT as an early predictor of tumor response to therapy (treatment naive or recurrent disease). Subjects are imaged with FLT and FDG PET pre-therapy, following 2 cycles of therapy and post therapy.
- The second arm will assess lymphoma patients with FDG PET positive residual mass. Subjects are imaged with FLT PET prior to standard of care biopsy of residual mass. If initial FDG PET data is not available in DICOM format or is of suboptimal image quality, a repeat FDG PET/CT at the study site may be required.
- We will accrue 70 participants (40 in the early response arm and 30 in the residual mass arm) to this study.
|Contact: Yolanda McKinney, R.N.||(301) email@example.com|
|Contact: Karen A Kurdziel, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937|
|Walter Reed National Medical Center||Recruiting|
|Bethesda, Maryland, United States, 20301|
|Principal Investigator:||Karen A Kurdziel, M.D.||National Institutes of Health Clinical Center (CC)|