Clinical trial · Interventional
18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma
A Pilot Study of 18F Fluorothymidine (FLT) PET/CT in Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: * Positron emission tomography (PET) uses radioactive substances called radiotracers to locate areas of cancer in the body. For this test, the patient is given an injection of the radiotracer 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 radiotracer 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 National Institutes of Health (NIH) Clinical Center or in the Cancer and Leukemia Group B (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 has viable 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [3'-deoxy-3'-[F-18] fluorothymidine | Other | — | UNRESOLVED |
| Biopsy | Procedure | — | UNRESOLVED |
| computed tomography | Procedure | — | UNRESOLVED |
| fine-needle aspiration | Procedure | — | UNRESOLVED |
| fluorodeoxyglucose F 18 Positron Emission Tomography and computed tomography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A - Participants Scanned at Baseline & After Chemotherapy
- description
- Patients undergo 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose 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.
- interventionNames
- Diagnostic Test: fluorodeoxyglucose F 18 Positron Emission Tomography and computed tomography
- Other: [3'-deoxy-3'-[F-18] fluorothymidine
- Procedure: computed tomography
- type
- EXPERIMENTAL
- label
- Group B - Participants Scanned in the Evaluation of Residual Masses After Therapy
- description
- Patients who have completed treatment in whom FDG-PET shows a remaining tumor mass undergo an FLT PET/CT scan . Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated.
- interventionNames
- Procedure: Biopsy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
* INCLUSION CRITERIA: Participant must be enrolled in a lymphoma therapy study at the National Institutes of Health (NIH) Clinical Center OR be enrolled in the Cancer and Leukemia Group B (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 National Cancer Institute (NCI) or from an outside pathology laboratory. Participant must be 18 years or older. Eastern Cooperative Oncology Group (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 (18)F-fluorodeoxyglucose (FDG) positron emission tomography (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 Principal Investigator (PI) or associates to make the patient ineligible for protocol procedures.
References
Publications (2)
- BACKGROUNDSpaepen K, Stroobants S, Dupont P, Vandenberghe P, Thomas J, de Groot T, Balzarini J, De Wolf-Peeters C, Mortelmans L, Verhoef G. Early restaging positron emission tomography with ( 18)F-fluorodeoxyglucose predicts outcome in patients with aggressive non-Hodgkin's lymphoma. Ann Oncol. 2002 Sep;13(9):1356-63. doi: 10.1093/annonc/mdf256. PMID 12196360
- BACKGROUNDJemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin. 2007 Jan-Feb;57(1):43-66. doi: 10.3322/canjclin.57.1.43. PMID 17237035