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

December 26, 2023 updated by: Baptist Health South Florida

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • Axumin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sensitivity for PET/CT
Time Frame: through study completion, an average of 1 year
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
Change in sensitivity for MRI
Time Frame: through study completion, an average of 1 year
To calculate the sensitivity of pre-treatment contrast-enhanced MRI.
through study completion, an average of 1 year
Change in the standardized uptake value (SUV) parameters
Time Frame: through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare change of SUV metrics of 18F-fluciclovine PET
Time Frame: baseline
To calculate the pre-, interim-, and post-treatment SUV metrics of 18F-fluciclovine PET uptake
baseline
Compare change of SUV metrics of contrast-enhanced MRI
Time Frame: baseline
To calculate the percent change in lesion volume on contrast-enhanced MRI (∆MRIvolume).
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baptist Health South Florida

Collaborators

Blue Earth Diagnostics

Investigators

  • Principal Investigator: Rupesh R Kotecha, MD, Miami Cancer Institute (MCI) at Baptist Health, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 11, 2020

First Submitted That Met QC Criteria

December 28, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Estimated)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 26, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-KOT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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