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NCT06048094 | RECRUITING | Brain Metastases

18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery
Sponsor:

Baptist Health South Florida

Brief Summary:

This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.

Condition or disease

Brain Metastases

Brain Metastases, Adult

Brain Cancer

Intervention/treatment

18F fluciclovine

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 46 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : 18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery (FACILITATE)
Actual Study Start Date : 2024-04-11
Estimated Primary Completion Date : 2026-05
Estimated Study Completion Date : 2027-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Diagnosis of cancer with radiographic finding of brain metastasis
  • * Any number of brain metastasis, with all lesions ≤ 2 cm in maximum dimension
  • * Planned treatment with SRS as per the treating physician team
  • * Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • * Individuals of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agree to use such a method during study participation up to an additional 1 week following the last 18F-fluciclovine PET
Exclusion Criteria
  • * Prior anaphylactic reaction to 18F-fluciclovine
  • * Radiographic evidence of leptomeningeal disease
  • * Prior whole-brain radiation therapy
  • * Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker)
  • * Pregnant or positive serum pregnancy test within 14 days of registration
  • * Individuals expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding for 24 hours after the time of imaging is allowed.
  • * Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol and/or preclude informed consent\*
  • * A legally authorized representative (LAR) may consent on a potential participant's behalf in the case of cognitive impairment, if in the investigator's opinion, that impairment would not prevent completion of the protocol.
18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery

Location Details

NCT06048094

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How to Participate

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Locations

RECRUITING

United States, Florida

Miami Cancer Institute

Miami, florida, United States, 33176