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NCT00416455 · ClinicalTrials.gov registry record · Phase 1
Fludeoxyglucose (FDG) F 18 PET Scan, CT Scan, and Ferumoxtran-10 MRI Scan Before Chemotherapy and Radiation Therapy in Finding Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer or High-Risk Endometrial Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 384
- Enrollment target
NCT00416455: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00416455 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 384 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (540% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00416455, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 384 participants
- Enrollment target
Study Summary
This phase I/II trial is studying how well fludeoxyglucose F 18 PET scan, CT scan, and ferumoxtran-10 MRI scan finds lymph node metastasis before undergoing chemotherapy and radiation therapy in patients with locally advanced cervical cancer or high-risk endometrial cancer. Diagnostic procedures, such as a fludeoxyglucose F 18 positron emission tomography (PET) scan, computed tomography (CT) scan, and ferumoxtran-10 magnetic resonance imaging (MRI) scan, may help find lymph node metastasis in patients with cervical cancer or endometrial cancer.
Primary Outcome
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported sensitivity is reader average sensitivity by seven experienced PET-CT readers.
Interventions
- RADIATION fludeoxyglucose F 18
- PROCEDURE positron emission tomography
- PROCEDURE computed tomography
- PROCEDURE magnetic resonance imaging
- DRUG ferumoxtran-10
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 384 participants |
| Start Date | 2007-09 |
| Est. Completion | 2016-07-16 |
| Phase | Phase 1 |
What the finished NCT00416455 record still lists
NCT00416455 is an interventional study that assigns participants to a tested intervention. The registered 384 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (540% higher).
The record links to 0 conditions, and to 5 interventions - of which fludeoxyglucose F 18 is the first listed.
NCT00416455 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00416455 about?
NCT00416455 is a clinical study titled "Fludeoxyglucose (FDG) F 18 PET Scan, CT Scan, and Ferumoxtran-10 MRI Scan Before Chemotherapy and Radiation Therapy in Finding Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer or High-Risk Endometrial Cancer". This phase I/II trial is studying how well fludeoxyglucose F 18 PET scan, CT scan, and ferumoxtran-10 MRI scan finds lymph node metastasis before undergoing chemotherapy and radiation therapy in patients with locally advanced cervical cancer or high-risk endometrial cancer. Diagnostic procedures, su...
What is the current status of trial NCT00416455?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 384 participants. The study started on 2007-09. Estimated completion is 2016-07-16.
What interventions are being tested in trial NCT00416455?
The interventions under investigation include: fludeoxyglucose F 18 (RADIATION), positron emission tomography (PROCEDURE), computed tomography (PROCEDURE), magnetic resonance imaging (PROCEDURE), ferumoxtran-10 (DRUG).
Who is sponsoring clinical trial NCT00416455?
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 NCT00416455's enrollment target sits among peer trials
384 81st of 2000 higher than 1,920 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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