Using a special imaging agent to evaluate brain metastases after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.