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NCT04018053 · ClinicalTrials.gov registry record · Early Phase 1
18Fluorine-Fluciclovine PET/CT for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy
A Early Phase 1 study of Bladder Cancer and Urothelial Carcinoma, sponsored by Brigham and Women's Hospital.
- Active
- Registry status
- Early Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT04018053: Active Early Phase 1 study of Bladder Cancer and Urothelial Carcinoma, sponsored by Brigham and Women's Hospital.
NCT04018053 is a Early Phase 1 study of Bladder Cancer and Urothelial Carcinoma that is active but no longer recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 16 participants, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04018053, a Early Phase 1 study of Bladder Cancer and Urothelial Carcinoma, is active but no longer recruiting, sponsored by Brigham and Women's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
This research study is studying a positron emission tomography (PET) agent called 18F-fluciclovine to evaluate how well 18F-fluciclovine-PET scans determine the extent of muscle invasive bladder cancer (as compared to regular CT and MRI imaging) and whether 18F-fluciclovine-PET scans can provide information about the pathologic grade of the tumor.
Primary Outcome
Lymph nodes will be classified as positive or negative for metastatic disease on 18F-fluciclovine PET/CT and compared to pathologic stage as determined from surgery.
Conditions Studied
Interventions
- DRUG 18F-fluciclovine
- DEVICE PET/CT
Study Locations (1)
Massachusetts
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2020-02-26 |
| Est. Completion | 2026-07-01 |
| Phase | Early Phase 1 |
What the registry record for NCT04018053 still lists
NCT04018053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 2 interventions - of which 18F-fluciclovine is the first listed.
NCT04018053 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04018053 about?
NCT04018053 is a clinical study titled "18Fluorine-Fluciclovine PET/CT for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy". This research study is studying a positron emission tomography (PET) agent called 18F-fluciclovine to evaluate how well 18F-fluciclovine-PET scans determine the extent of muscle invasive bladder cancer (as compared to regular CT and MRI imaging) and whether 18F-fluciclovine-PET scans can provide inf...
What is the current status of trial NCT04018053?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 16 participants. The study started on 2020-02-26. Estimated completion is 2026-07-01.
What conditions does trial NCT04018053 study?
This clinical trial studies the following conditions: Bladder Cancer, Urothelial Carcinoma.
What interventions are being tested in trial NCT04018053?
The interventions under investigation include: 18F-fluciclovine (DRUG), PET/CT (DEVICE).
Who is sponsoring clinical trial NCT04018053?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04018053 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04018053's enrollment target sits among peer trials
16 160th of 175 higher than 14 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer 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.
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