Using a special imaging agent to evaluate brain metastases after surgery
Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis
PHASE2 · Baptist Health South Florida · NCT05554302
This study is testing a special imaging agent to see if it can help doctors find leftover brain tumors after surgery and improve care for patients with brain cancer.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Baptist Health South Florida (other) |
| Drugs / interventions | Chemotherapy, Radiation |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT05554302 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients who have undergone surgery to remove brain metastases and are scheduled for stereotactic radiosurgery (SRS). Participants may opt for a pre-surgery PET/CT scan using the investigational agent 18F-Fluciclovine. The primary aim is to assess whether this imaging agent can provide better insights into the extent of the surgery and detect any residual tumor that MRI might miss, as well as improve the detection of recurring disease. This approach could enhance the overall management of brain cancer post-surgery.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of brain metastasis who are scheduled for surgical intervention and postoperative SRS.
Not a fit: Patients who are not undergoing surgery for brain metastases or those with a performance status outside the ECOG 0-3 range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection and management of brain metastases, potentially enhancing patient outcomes.
How similar studies have performed: While the use of 18F-Fluciclovine in other contexts has shown promise, its application specifically for imaging brain metastases is still investigational and not widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Performance status, Eastern Cooperative Oncology Group (ECOG) 0-3 3. Radiographic diagnosis of brain metastasis 4. Patient planned for surgical intervention for at least 1 metastasis 5. Patient planned for postoperative SRS Male or female patients of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 1 week after post-treatment 18F-Fluciclovine PET/CT. Highly effective and acceptable forms of contraception are: * Male condom plus spermicide * Cap plus spermicide * Diaphragm plus spermicide * Copper T * Progesterone T * Levonorgestrel-releasing intrauterine system (e.g., Mirena®) * Implants * Hormone shot or injection * Combined pill * Mini-pill * Patch Postmenopausal people on the study (that will not need contraception) is defined as at least one of the following: * Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments * Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50 * Radiation-induced oophorectomy with last menses \> 1 year ago * Chemotherapy-induced menopause with \>1 year interval since last menses * Surgical sterilization (bilateral oophorectomy or hysterectomy). Exclusion Criteria: 1. Prior anaphylactic reaction to 18F-Fluciclovine 2. Evidence of leptomeningeal disease 3. Prior whole-brain radiation therapy 4. Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker) 5. Pregnant at the expected time of 18F-fluciclovine administration 6. Expecting to be breastfeeding at the time of 18F-Fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding 24 hours after the time of imaging is allowed.
Where this trial is running
Miami, Florida
- Miami Cancer Institute at Baptist Health South Florida — Miami, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Rupesh R Kotecha, M.D. — Miami Cancer Institute/Baptist Health South Florida
- Study coordinator: Rupesh R Kotecha, M.D.
- Email: rupeshk@baptisthealth.net
- Phone: 17865962000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brain Metastases, Brain Cancer, Brain metastases, Brain cancer, Stereotactic radiosurgery