18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma



Status:Terminated
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 100
Updated:2/13/2019
Start Date:September 29, 2008
End Date:October 23, 2014

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A Pilot Study of 18F Fluorothymidine (FLT) PET/CT in Lymphoma

Background:

- 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.

Objectives:

- To test the use of FLT PET/CT imaging in assessing treatment response in patients with
lymphoma.

Eligibility:

- 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.

Design:

- 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.

Background:

- 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.

Primary Objectives:

- 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.

Eligibility:

- 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.

Design:

- 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.

- INCLUSION CRITERIA:

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.

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.

Participant must be 18 years or older.

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 FDG 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 PI or associates to make the patient ineligible for
protocol procedures.
We found this trial at
2
sites
Bethesda, Maryland 20301
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from
Bethesda, MD
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9000 Rockville Pike
Bethesda, Maryland 20892
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from
Bethesda, MD
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