18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma
A Pilot Study of 18F Fluorothymidine (FLT) PET/CT in Lymphoma
2 other identifiers
interventional
31
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 lymphoma
Started Sep 2008
Typical duration for phase_1 lymphoma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 29, 2008
CompletedFirst Submitted
Initial submission to the registry
October 17, 2008
CompletedFirst Posted
Study publicly available on registry
October 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2014
CompletedResults Posted
Study results publicly available
March 11, 2021
CompletedMarch 11, 2021
February 1, 2021
6.1 years
October 17, 2008
November 30, 2020
February 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With the Presence/Absence of Abnormal 18F- Fluorothymidine (FLT) Uptake, and Positive/Negative Biopsy
A positive malignant residual mass was defined as focal 18F- Fluorothymidine (FLT) uptake within the residual mass greater than the normal mediastinal background uptake. FLT uptake within the mass lower than the mediastinal was considered non-malignant. The positive/negative FLT uptake was correlated with biopsy results within the residual mass (presence or absence of malignant tumor cells).
Up to 3.5 years
Secondary Outcomes (8)
18F- Fluorothymidine (FLT) Uptake Within the Tumor(s) Between Baseline vs Completion of Therapy Scans
up to 4.5 years
Tumor(s) Maximum Standard Uptake Value (SUVmax) at Baseline Scan and SUVmax After Completion Scan in Responders and Non-responders' Patients
up to 4.5 years
Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax)
Up to 4.5 years
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection
up to 3.5 years
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection
up to 3.5 years
- +3 more secondary outcomes
Other Outcomes (1)
Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Date treatment consent signed to date off study, approximately 4 years, 7 months and 9 days.
Study Arms (2)
Group A - Participants Scanned at Baseline & After Chemotherapy
EXPERIMENTALPatients 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.
Group B - Participants Scanned in the Evaluation of Residual Masses After Therapy
EXPERIMENTALPatients 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.
Interventions
Biopsy taken
Imaging
Undergo scans
Undergo scans
sample collected
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Walter Reed National Medical Center
Bethesda, Maryland, 20301, United States
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (2)
Spaepen 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: 12196360BACKGROUNDJemal 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: 17237035BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Esther Mena
- Organization
- National Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Esther Mena, M.D.
National Cancer Institute (NCI)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 17, 2008
First Posted
October 20, 2008
Study Start
September 29, 2008
Primary Completion
October 23, 2014
Study Completion
October 23, 2014
Last Updated
March 11, 2021
Results First Posted
March 11, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share