Phase 1 Brain Cancer Trial, Recruiting NCT04689048 Sponsor: Baptist Health South Florida Condition: Brain Cancer
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Phase 1 Brain Cancer Trial, Recruiting

NCT04689048
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older, of any gender
  • People who are reasonably well and able to carry out daily activities (as assessed by their doctor using a standard scale called the ECOG scale, with a score of 0, 1, or 2)
  • People who have been diagnosed with cancer that has spread to the brain, with at least one affected area in the brain larger than 2 cm that has not yet been treated
  • People whose medical team has already planned a specific type of focused radiation treatment for their brain metastases
  • Women who could become pregnant must have a negative blood pregnancy test within 14 days before joining the trial
  • Women who could become pregnant must have been using a highly effective form of contraception for at least 4 weeks before the screening visit, and must agree to continue using contraception throughout the study and for at least 1 week after the final scan

Who may not be able to join:

  • People who have previously had a severe allergic reaction to the imaging agent used in this trial (called 18F-fluciclovine)
  • People whose cancer has spread to the fluid or lining surrounding the brain and spinal cord
  • People who have previously had whole-brain radiation therapy
  • People who are unable to have an MRI scan (for example, those with a pacemaker or other safety-related reasons)
  • Women who are pregnant at the time the imaging scan is scheduled
  • Women who are breastfeeding at the time of the scan and are not willing to pause breastfeeding for 24 hours after the scan is done (a 24-hour pause after the scan is considered acceptable)
  • People with serious medical conditions or significant mental health or cognitive difficulties that, in the opinion of the trial doctor, would prevent safe participation or the ability to give informed consent

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Rupesh R Kotecha, MD, Miami Cancer Institute (MCI) at Baptist Health, Inc.

Phone: 17865962000

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Baptist Health South Florida
Registry
ClinicalTrials.gov
Start date
4 April 2022
Est. completion
1 March 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in sensitivity for PET/CT; Change in sensitivity for MRI; Change in the standardized uptake value (SUV) parameters

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov