Phase 2 Brain Cancer Trial, Recruiting NCT05554302 Sponsor: Baptist Health South Florida Condition: Brain Cancer
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Phase 2 Brain Cancer Trial, Recruiting

NCT05554302
Recruiting Phase 2

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
  • People whose general health and ability to carry out daily activities falls within a certain range, as measured by a standard oncology scale called ECOG 0–3 (confirm with trial site)
  • People who have been diagnosed with brain metastases (cancer that has spread to the brain) confirmed by imaging scans
  • People who are scheduled to have surgery to remove at least one brain metastasis
  • People who are planned to receive a targeted form of radiation therapy called stereotactic radiosurgery (SRS) after their surgery
  • People of reproductive potential who are willing and able to use two reliable forms of contraception for at least 4 weeks before the screening stage, throughout the study, and for 1 week after the final imaging scan — acceptable methods include male condoms with spermicide, a diaphragm or cap with spermicide, a copper IUD, a hormonal IUD (such as Mirena®), implants, hormone injections, combined contraceptive pills, the mini-pill, or the contraceptive patch
  • People who are postmenopausal (and therefore do not need contraception) — this includes those who have had no periods for 1 or more years after stopping hormone treatment, those with hormone levels confirmed in the postmenopausal range, those whose menopause was caused by radiation or chemotherapy with no period for more than 1 year, or those who have had surgical removal of both ovaries or a hysterectomy

Who may not be able to join:

  • People who have previously had a severe allergic reaction (anaphylaxis) to the imaging agent 18F-Fluciclovine
  • People who have evidence of cancer spreading along the lining of the brain or spinal cord (leptomeningeal disease)
  • People who have previously received whole-brain radiation therapy
  • People who are unable to have an MRI scan, for example due to having a pacemaker or another safety-related reason
  • People who are pregnant at the time the imaging agent 18F-Fluciclovine is scheduled to be given
  • People who are breastfeeding at the time of the imaging scan and are unwilling to stop breastfeeding for 24 hours after the scan (a temporary pause in breastfeeding for 24 hours after imaging is considered acceptable)

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 22 July 2026
Phase 2: approximately ~30% 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, M.D., Miami Cancer Institute/Baptist Health South Florida

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 2
Sponsor
Baptist Health South Florida
Registry
ClinicalTrials.gov
Start date
10 January 2023
Est. completion
1 January 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in conformality index of tumor target volume delineation; Change in PET scan 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: 22 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