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

Description

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.

Conditions

Brain Metastases, Adult, Brain Metastases, Brain Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Brain Metastases, Adult
Intervention / Treatment

-

Contacts and Locations

Miami

Miami Cancer Institute, Miami, Florida, United States, 33176

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Baptist Health South Florida,

Rupesh R Kotecha, MD, PRINCIPAL_INVESTIGATOR, Miami Cancer Institute (MCI) at Baptist Health, Inc.

Study Record Dates

2025-12