Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis

Brain Metastases Clinical Trial

— CONCORDANT  

Official title:

Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05554302
• Other study ID #: 2021-KOT-003
• Status: Recruiting
• Phase: Phase 2
• Start date: January 10, 2023
• Est. completion date: June 30, 2025

Study information

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

Clinical Trial Summary

This study is for patients who have had surgery to remove brain metastasis and are planned to have stereotactic radiosurgery (SRS) after their brain surgery. It will be optional for patients to have a pre-surgery 18F-Fluciclovine PET/CT scan. The goal of the study is to determine whether a specific imaging agent, known as 18F-Fluciclovine, will help physicians evaluate the extent of surgery and determine if there is any visible tumor above what MRI alone can identify as well as improve the physicians' ability to detect recurring disease. This agent (18F-Fluciclovine) is investigational for the imaging of brain metastases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Cancer
• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• 18F-Fluciclovine
Patients will receive 5-mCi dose (+/- 20%) 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 at Baptist Health South Florida	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Baptist Health South Florida	Blue Earth Diagnostics

Country where clinical trial is conducted

United States, 

References & Publications (23)

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in conformality index of tumor target volume delineation	The tumor target volume (post-operative cavity and any residual or recurrent disease) will be delineated by post-operative MRI only. A second target volume will be generated using the 18F-Fluciclovine PET-defined volume. The conformality index is calculated by comparing the PET-defined tumor volume with MRI-defined tumor volume. Non-overlapping and overlapping regions regions of PET tumor volume and MRI tumor volume will be used to calculate conformality indices.	3 weeks, 6 and 12 months
Primary	Change in PET scan standardized uptake value (SUV) parameters	The standardized uptake value (SUV) parameters of SUVpeak, SUVmean, and SUVmax will be measured to determine if they correlate tumor volume and can predict risk of recurrence.	3 weeks, 6 and 12 months
Secondary	Time to local failure	Each lesion will be followed from pre-treatment PET to local failure or re-retreatment; death; 12 months from pre-treatment PET; lost-to follow-up, discontinuation, or withdrawal; or end of study. In the event that a patient has more than one study eligible lesion, the patient will discontinue follow up after all lesions progress, or will be censored as above. Death will be treated as a competing event.	1 year