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

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.

Conditions

Brain Metastases, Brain Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Brain Metastases
Intervention / Treatment

-

Contacts and Locations

Miami

Miami Cancer Institute at Baptist Health South Florida, 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. 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
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  • * 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
  • * 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).
  • 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.

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

Study Record Dates

2030-01