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NCT00775268 · ClinicalTrials.gov registry record · Phase 1
18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT00775268: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00775268 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00775268, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study 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
Primary Outcome
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).
Interventions
- PROCEDURE Biopsy
- PROCEDURE computed tomography
- PROCEDURE fine-needle aspiration
- DIAGNOSTIC_TEST fluorodeoxyglucose F 18 Positron Emission Tomography and computed tomography
- OTHER [3'-deoxy-3'-[F-18] fluorothymidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2008-09-29 |
| Est. Completion | 2014-10-23 |
| Phase | Phase 1 |
Why NCT00775268 stopped before completion
NCT00775268 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 5 interventions - of which Biopsy is the first listed.
NCT00775268 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00775268 about?
NCT00775268 is a clinical study titled "18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma". 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 accum...
What is the current status of trial NCT00775268?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2008-09-29. Estimated completion is 2014-10-23.
What interventions are being tested in trial NCT00775268?
The interventions under investigation include: Biopsy (PROCEDURE), computed tomography (PROCEDURE), fine-needle aspiration (PROCEDURE), fluorodeoxyglucose F 18 Positron Emission Tomography and computed tomography (DIAGNOSTIC_TEST), [3'-deoxy-3'-[F-18] fluorothymidine (OTHER).
Who is sponsoring clinical trial NCT00775268?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00775268's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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