Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery

Brain Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04689048
• Other study ID #: 2019-KOT-001
• Status: Recruiting
• Phase: Phase 1
• Start date: April 4, 2022
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Baptist Health South Florida
• Contact: Rupesh C Kotecha, MD
• Phone: 17865962000
• Email: rupeshk[@]baptisthealth.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female, age =18 years

2. Performance status, Eastern Cooperative Oncology Group 0-2

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

4. Plan for SSRS per the treating team

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

6. 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

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. Females pregnant at the expected time of 18F-fluciclovine administration

6. Females who are 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

7. Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent

Related Conditions & MeSH terms

• Brain Cancer
• Brain Metastases
• Brain Metastases, Adult
• Brain Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Drug:
• 18F fluciclovine
Patients will receive a standard 5 millicuries dose of 18F-fluciclovine intravenously as a bolus injection. They will be required to fast for at least four hours prior to 18F-fluciclovine injection. Patients will be positioned for PET/CT brain imaging and will be injected with 18F-fluciclovine immediately prior to PET data acquisition. PET data will be collected in list mode up to 25 minutes post-injection. PET images will be reconstructed in two ways: as a standard static image of data acquired between 10 to 20 minutes post-injection, and as a dynamic series of four 5-minute frames between 5 to 25 minutes post-injection to allow for motion assessment and correction and time-dependent observations.

Locations

Country	Name	City	State
United States	Miami Cancer Institute	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Baptist Health South Florida	Blue Earth Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sensitivity for PET/CT	Calculate the sensitivity of pre-treatment 18F-fluciclovine PET/CT to identify brain metastases >2 cm treated with SSRS.	through study completion, an average of 1 year
Primary	Change in sensitivity for MRI	To calculate the sensitivity of pre-treatment contrast-enhanced MRI.	through study completion, an average of 1 year
Primary	Change in the standardized uptake value (SUV) parameters	To identify a change in the standardized uptake value (SUV) parameters (SUVpeak, SUVmean, and SUVmax) for the 18F-fluciclovine PET/CT scans.	through study completion, an average of 1 year
Secondary	Compare change of SUV metrics of 18F-fluciclovine PET	To calculate the pre-, interim-, and post-treatment SUV metrics of 18F-fluciclovine PET uptake	baseline
Secondary	Compare change of SUV metrics of contrast-enhanced MRI	To calculate the percent change in lesion volume on contrast-enhanced MRI (?MRIvolume).	baseline

External Links

•   Miami Cancer Institute website