RECRUITING

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

Conditions

Brain Metastases Brain Metastases, Adult Brain Cancer stereotactic radiosurgery 18F-flucicloivine PET imaging

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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 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.

Official Title

18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery (FACILITATE)

Quick Facts

Study Start:2024-04-11

Study Completion:2027-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06048094

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 Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Rupesh Kotecha, M.D.

CONTACT

(786) 596-2000

RupeshK@baptisthealth.net

Antoinette Pimental

CONTACT

(786) 596-2000

Antoinette.Pimentel@baptisthealth.net

Principal Investigator

Rupesh Kotecha, M.D.

PRINCIPAL_INVESTIGATOR

Miami Cancer Institute at Baptist Health, Inc.

Study Locations (Sites)

Miami Cancer Institute

Miami, Florida, 33176

United States

Collaborators and Investigators

Sponsor: Baptist Health South Florida

Rupesh Kotecha, M.D., PRINCIPAL_INVESTIGATOR, Miami Cancer Institute 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 Date2024-04-11

Study Completion Date2027-05

Study Record Updates

Study Start Date2024-04-11

Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

stereotactic radiosurgery
18F-flucicloivine
PET imaging

Additional Relevant MeSH Terms

Brain Metastases
Brain Metastases, Adult
Brain Cancer