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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

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


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


- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Diagnostic accuracy of 3'-deoxy-3'-[18F] fluorothymidine (FLT PET/CT scans as an early indicator of complete response to therapy.

Safety Issue:

No

Principal Investigator

Karen A Kurdziel, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institutes of Health Clinical Center (CC)

Authority:

United States: Federal Government

Study ID:

080200

NCT ID:

NCT00775268

Start Date:

September 2008

Completion Date:

June 2013

Related Keywords:

  • Lymphoma
  • 18F Fluorothymidine
  • PET/CT
  • FLT
  • Lymphoma
  • FDG
  • Lymphoma

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892
Walter Reed National Medical CenterBethesda, Maryland  20301