Status:
RECRUITING
Feasibility of 18F-Fluciclovine PET/CT to Identify Brain Metastasis
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
Blue Earth Diagnostics
Conditions:
Brain Metastases
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
The goal of this diagnostic intervention clinical trial is to compare 18F-Fluciclovine uptake within brain lesions over 60 minutes compared with standard of care positive histology confirmation or con...
Detailed Description
This is a single-arm, 20 subject, pilot clinical trial utilizing 18F-fluciclovine PET/CT scan prior to treatment for brain metastatic lesion(s). Patients with recently diagnosed brain metastatic lesio...
Eligibility Criteria
Inclusion
- Patients with clinically suspected or diagnosed brain metastatic lesion(s)
- Age ≥ 18 years
- Known history cancer
- Brain MRI in the past 2 months positive for metastatic disease
- Scheduled for treatment: Surgical resection, or stereotactic radiosurgery, or whole brain radiation therapy.
- Can tolerate 18F-fluciclovine PET/CT exam (can lie still on their back for the duration of the scan)
- Ability to understand and the willingness to sign a written informed consent
Exclusion
- Patients who do not meeting inclusion criteria.
- 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).
- Patients who have had prior brain surgery or radiation treatment of the index lesion(s).
- 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.
- 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.
- Inability to tolerate 18F-fluciclovine PET/CT exam
- Enrollment delays patient care
- Concurrent or prior enrollment on other clinical trials would not exclude patients, as long as all other eligibility criteria are met.
Key Trial Info
Start Date :
September 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06055790
Start Date
September 10 2024
End Date
October 31 2026
Last Update
September 3 2025
Active Locations (1)
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1
Arizona Cancer Center at UMC North/University Medical Center
Tucson, Arizona, United States, 85719