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NCT05554302 · ClinicalTrials.gov registry record · Phase 2
Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis
A Phase 2 study of Brain Metastases and Brain Cancer, sponsored by Baptist Health South Florida.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05554302: Recruiting Phase 2 study of Brain Metastases and Brain Cancer, sponsored by Baptist Health South Florida.
NCT05554302 is a Phase 2 study of Brain Metastases and Brain Cancer that is actively recruiting participants, run by Baptist Health South Florida. The registered enrollment target is 20 participants, below the 213-participant average among 67 other Brain Metastases trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05554302, a Phase 2 study of Brain Metastases and Brain Cancer, is actively recruiting participants, sponsored by Baptist Health South Florida.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is for patients who have had surgery to remove brain metastasis and are planned to have stereotactic radiosurgery (SRS) after their brain surgery. It will be optional for patients to have a pre-surgery 18F-Fluciclovine PET/CT scan. The goal of the study is to determine whether a specific imaging agent, known as 18F-Fluciclovine, will help physicians evaluate the extent of surgery and determine if there is any visible tumor above what MRI alone can identify as well as improve the physicians' ability to detect recurring disease. This agent (18F-Fluciclovine) is investigational for the imaging of brain metastases.
Primary Outcome
The tumor target volume (post-operative cavity and any residual or recurrent disease) will be delineated by post-operative MRI only. A second target volume will be generated using the 18F-Fluciclovine PET-defined volume. The conformality index is calculated by comparing the PET-defined tumor volume with MRI-defined tumor volume. Non-overlapping and overlapping regions regions of PET tumor volume and MRI tumor volume will be used to calculate conformality indices.
Conditions Studied
Interventions
- DRUG 18F-Fluciclovine
Study Locations (1)
Florida
- Miami Cancer Institute at Baptist Health South Florida - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-01-10 |
| Est. Completion | 2030-01 |
| Phase | Phase 2 |
What NCT05554302 shows while recruiting
NCT05554302 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 213-participant average among 67 other Brain Metastases trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Brain Metastases appearing as the primary indexed condition, and to 1 intervention - of which 18F-Fluciclovine is the first listed.
NCT05554302 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05554302 about?
NCT05554302 is a clinical study titled "Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis". This study is for patients who have had surgery to remove brain metastasis and are planned to have stereotactic radiosurgery (SRS) after their brain surgery. It will be optional for patients to have a pre-surgery 18F-Fluciclovine PET/CT scan. The goal of the study is to determine whether a specific ...
What is the current status of trial NCT05554302?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2023-01-10. Estimated completion is 2030-01.
What conditions does trial NCT05554302 study?
This clinical trial studies the following conditions: Brain Metastases, Brain Cancer.
What interventions are being tested in trial NCT05554302?
The interventions under investigation include: 18F-Fluciclovine (DRUG).
Who is sponsoring clinical trial NCT05554302?
This trial is sponsored by Baptist Health South Florida, which has 40 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05554302 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Brain Metastases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05554302's enrollment target sits among peer trials
20 51st of 67 higher than 9 of 67 other Brain Metastases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Metastases 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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