Characterization of Large Brain Metastases With 18F-Fluciclovine PET/CT Treated With Staged Stereotactic Radiosurgery

Who is this study for? Patients with large brain metastases
What treatments are being studied? 18F fluciclovine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer. This study is being done to determine whether the use of a new imaging agent, 18F-fluciclovine, is able to detect which patients are responding to radiation therapy. In addition, this study will look at the changes of the treated brain metastases using this imaging agent over time.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female, age ≥18 years

• Performance status, Eastern Cooperative Oncology Group 0-2

• Confirmed diagnosis of brain metastases with at least one untreated lesion \>2 cm in maximum diameter

• Plan for SSRS per the treating team

• For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required

• For females of reproductive potential: use of highly effective 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 positron emission tomography/computerized tomography

Locations
United States
Florida
Miami Cancer Institute
RECRUITING
Miami
Contact Information
Primary
Rupesh C Kotecha, MD
rupeshk@baptisthealth.net
17865962000
Backup
Kristy Reyes
Kristina.Reyes@baptisthealth.net
786-524-7311
Time Frame
Start Date: 2022-04-04
Estimated Completion Date: 2026-12
Participants
Target number of participants: 20
Treatments
Other: PET/CT, MRI
In total, three 18F-fluciclovine PET/CT brain scans (pre-, interim-, and post-treatment) will be performed according to the study calendar. Generic name is Axumin and will be administered as an intravenous bolus. May administer diluted or undiluted. The maximum volume of undiluted 18F-fluciclovine is 5 mL. After administration, flush with normal saline to ensure full delivery of the dose.
Related Therapeutic Areas
Sponsors
Collaborators: Blue Earth Diagnostics
Leads: Baptist Health South Florida

This content was sourced from clinicaltrials.gov