Using 18F-Fluciclovine PET/CT to Identify Brain Metastasis

Feasibility of 18F-Fluciclovine PET/CT to Identify Brain Metastasis

This study is testing if a special type of PET scan can help doctors find brain metastases more accurately in patients who have unclear MRI results.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: University of Arizona (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Tucson, Arizona)
• Trial ID: NCT06055790 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of 18F-Fluciclovine PET/CT scans in identifying brain metastases by comparing the uptake of the tracer in brain lesions over a 60-minute period. Participants will undergo two PET/CT scans: one before treatment and another after treatment to assess changes in tracer uptake. The study seeks to differentiate between true local progression of the disease and radionecrosis in patients with uncertain MRI results. The findings will be plotted on a time activity curve to analyze the dynamics of tracer uptake in both treated and untreated lesions.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with clinically suspected or diagnosed brain metastatic lesions who are scheduled for treatment.

Not a fit: Patients who have had prior brain surgery or radiation treatment of the index lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of diagnosing and monitoring brain metastases, leading to better treatment decisions for patients.

How similar studies have performed: While the use of 18F-Fluciclovine in other contexts has shown promise, this specific application for brain metastases is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Patients with clinically suspected or diagnosed brain metastatic lesion(s)
2. Age ≥ 18 years
3. Known history cancer
4. Brain MRI in the past 2 months positive for metastatic disease
5. Scheduled for treatment: Surgical resection, or stereotactic radiosurgery, or whole brain radiation therapy.
6. Can tolerate 18F-fluciclovine PET/CT exam (can lie still on their back for the duration of the scan)
7. Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

1. Patients who do not meeting inclusion criteria.
2. Patients who have had a brain biopsy of the index lesion(s) sooner than 4 weeks from the brain 18F-fluciclovine PET/CT (to minimize false positive uptake due to inflammation).
3. Patients who have had prior brain surgery or radiation treatment of the index lesion(s).
4. Patients who have had treatment of the index brain lesion(s) or initiation of systemic therapy after the last MRI and prior to the PET/CT scan.
5. Prior history of localized brain treatment (surgery or stereotactic radiosurgery /fractionated stereotactic radiotherapy) allowed, if at least one index lesion is not adjacent to previous treatment (10% isodose line of prior RT). Patients with only index lesion(s) within 10% isodose line of prior treatment would be excluded. For example, if ALL index lesions are within the 2.2Gy isodose line of previously treated lesions to 22Gy in 1 fractions, the patient would be ineligible, however if there is 1 index lesion not in the prior radiation field, then that patient would be eligible but all other lesions in prior radiation fields would be excluded from analysis.
6. Inability to tolerate 18F-fluciclovine PET/CT exam
7. Enrollment delays patient care
8. Concurrent or prior enrollment on other clinical trials would not exclude patients, as long as all other eligibility criteria are met.

Where this trial is running

Tucson, Arizona

• Arizona Cancer Center at UMC North/University Medical Center — Tucson, Arizona, United States (Recruiting)

Study contacts

• Principal investigator: Bital Savir-Baruch, MD — University of Arizona
• Study coordinator: Rachel E Jarrett, MPH

Conditions Brain Metastases