RECRUITING

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

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

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.

Official Title

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

Quick Facts

Study Start:2023-01-10
Study Completion:2030-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05554302

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. Age ≥ 18 years
  2. 2. Performance status, Eastern Cooperative Oncology Group (ECOG) 0-3
  3. 3. Radiographic diagnosis of brain metastasis
  4. 4. Patient planned for surgical intervention for at least 1 metastasis
  5. 5. Patient planned for postoperative SRS
  6. * Male condom plus spermicide
  7. * Cap plus spermicide
  8. * Diaphragm plus spermicide
  9. * Copper T
  10. * Progesterone T
  11. * Levonorgestrel-releasing intrauterine system (e.g., Mirena®)
  12. * Implants
  13. * Hormone shot or injection
  14. * Combined pill
  15. * Mini-pill
  16. * Patch
  17. * Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments
  18. * Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50
  19. * Radiation-induced oophorectomy with last menses \> 1 year ago
  20. * Chemotherapy-induced menopause with \>1 year interval since last menses
  21. * Surgical sterilization (bilateral oophorectomy or hysterectomy).
  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. Pregnant at the expected time of 18F-fluciclovine administration
  6. 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.

Contacts and Locations

Study Contact

Rupesh R Kotecha, M.D.
CONTACT
17865962000
rupeshk@baptisthealth.net
Antoinette Pimentel
CONTACT
17865962000
antoinette.pimentel@baptisthealth.net

Principal Investigator

Rupesh R Kotecha, M.D.
PRINCIPAL_INVESTIGATOR
Miami Cancer Institute/Baptist Health South Florida

Study Locations (Sites)

Miami Cancer Institute at Baptist Health South Florida
Miami, Florida, 33176
United States

Collaborators and Investigators

Sponsor: Baptist Health South Florida

  • Rupesh R Kotecha, M.D., PRINCIPAL_INVESTIGATOR, Miami Cancer Institute/Baptist Health South Florida

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 Date2023-01-10
Study Completion Date2030-01

Study Record Updates

Study Start Date2023-01-10
Study Completion Date2030-01

Terms related to this study

Keywords Provided by Researchers

  • Brain metastases
  • Brain cancer
  • Stereotactic radiosurgery

Additional Relevant MeSH Terms

  • Brain Metastases
  • Brain Cancer