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NCT00602043 · ClinicalTrials.gov registry record · Phase 2
F-18 16 Alpha-Fluoroestradiol-Labeled Positron Emission Tomography in Predicting Response to First-Line Hormone Therapy in Patients With Stage IV Breast Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT00602043: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00602043 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00602043, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This phase II trial is studying how well F-18 16 alpha-fluoroestradiol (FES) imaging works in predicting response to first-line hormone therapy in women with hormone receptor-positive metastatic breast cancer. Diagnostic procedures, such as FES imaging, may help predict how well patients will respond to hormone therapy and may help plan the best treatment.
Primary Outcome
Patients were expected to start endocrine therapy within 2 weeks of the FES PET scan. Response assessment was evaluated at 3 and 6 months. For patients with at least one site of measurable disease \[per response evaluation criteria in solid tumors (RECIST, version 1.1)\], size-based response criteria were used to assess response. For patients without disease evaluable by RECIST 1.1, largely patients with bone-dominant metastatic breast cancer, serial FDG PET scanning was used to determine respo
Interventions
- RADIATION fludeoxyglucose F 18
- PROCEDURE positron emission tomography
- PROCEDURE computed tomography
- RADIATION F-18 16 alpha-fluoroestradiol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2008-09 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
What the finished NCT00602043 record still lists
NCT00602043 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 4 interventions - of which fludeoxyglucose F 18 is the first listed.
NCT00602043 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00602043 about?
NCT00602043 is a clinical study titled "F-18 16 Alpha-Fluoroestradiol-Labeled Positron Emission Tomography in Predicting Response to First-Line Hormone Therapy in Patients With Stage IV Breast Cancer". This phase II trial is studying how well F-18 16 alpha-fluoroestradiol (FES) imaging works in predicting response to first-line hormone therapy in women with hormone receptor-positive metastatic breast cancer. Diagnostic procedures, such as FES imaging, may help predict how well patients will respon...
What is the current status of trial NCT00602043?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2008-09. Estimated completion is 2014-09.
What interventions are being tested in trial NCT00602043?
The interventions under investigation include: fludeoxyglucose F 18 (RADIATION), positron emission tomography (PROCEDURE), computed tomography (PROCEDURE), F-18 16 alpha-fluoroestradiol (RADIATION).
Who is sponsoring clinical trial NCT00602043?
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 NCT00602043's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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