RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-04-04
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04689048

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female, age ≥18 years
  2. 2. Performance status, Eastern Cooperative Oncology Group 0-2
  3. 3. Confirmed diagnosis of brain metastases with at least one untreated lesion \>2 cm in maximum diameter
  4. 4. Plan for SSRS per the treating team
  5. 5. For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required
  6. 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. 1. Prior anaphylactic reaction to 18F-fluciclovine
  2. 2. Evidence of leptomeningeal disease
  3. 3. Prior whole-brain radiation therapy
  4. 4. Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)
  5. 5. Females pregnant at the expected time of 18F-fluciclovine administration
  6. 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. 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

Contacts and Locations

Study Contact

Rupesh C Kotecha, MD
CONTACT
17865962000
rupeshk@baptisthealth.net
Antoinette Pimentel
CONTACT
17865962000
antoinette.pimentel@baptisthealth.net

Principal Investigator

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

Study Locations (Sites)

Miami Cancer Institute
Miami, Florida, 33176
United States

Collaborators and Investigators

Sponsor: Baptist Health South Florida

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

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 Registration Dates

Study Start Date2022-04-04
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-04-04
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • brain
  • brain metastases
  • brain metastases, adult
  • brain cancer
  • Stereotactic Radiosurgery

Additional Relevant MeSH Terms

  • Brain Metastases, Adult
  • Brain Metastases
  • Brain Cancer