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

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ClinicalTrials.gov Identifier: NCT06048094
Recruitment Status : Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : December 8, 2023
Sponsor:
Collaborator:
Blue Earth Diagnostics
Information provided by (Responsible Party):
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 Intervention/treatment Phase
Brain Metastases Brain Metastases, Adult Brain Cancer Drug: 18F fluciclovine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery (FACILITATE)
Estimated Study Start Date : February 2024
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : February 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 18F-Fluciclovine PET Imaging
Participants will undergo a 18F-fluciclovine PET scan at the time of their SRS planning magnetic resonance imaging (MRI). Then participants will undergo single-fraction SRS as standard of care (SOC). A second 18F-fluciclovine PET scan will be completed 8 weeks (± 2 weeks) after SRS.
Drug: 18F fluciclovine
Participants will receive 5-mCi dose (± 20%) of 18F-fluciclovine intravenously as a bolus injection immediately prior to PET data acquisition. PET data will be collected in list mode up to 25 minutes post-injection. PET images will be reconstructed in two ways: as a standard static image of data acquired between 10 to 20 minutes post-injection, and as a dynamic series of four 5-minute frames between 5 to 25 minutes post-injection to allow for motion assessment and correction and time-dependent observations.
Other Names:
  • Axumin
  • 18F-FACBC
  • (1r, 3r)-1-amino-3[18F] fluorocyclobutane-1-carboxylic acid




Primary Outcome Measures :
  1. Change in Standardized Uptake Value (SUV)-peak [ Time Frame: 8 weeks ]
    Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVpeak will be calculated for the pre-SRS and post-SRS imaging studies, as well as the percent change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.

  2. Change in SUVmean [ Time Frame: 8 weeks ]
    Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVmean will be calculated for the pre-SRS and post-SRS imaging studies, as well as the percent change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.

  3. Change in SUVmax [ Time Frame: 8 weeks ]
    Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVmax will be calculated for the pre-SRS and post-SRS imaging studies, as well as the change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.


Secondary Outcome Measures :
  1. Tumor Control [ Time Frame: 12 months ]
    Each lesion will be followed from pre-treatment PET to local failure or retreatment; death; lost-to follow-up, discontinuation, or withdrawal; or end of study. Local failure is defined as disease progression according to Response Assessment in Neuro-Oncology (RANO) criteria.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06048094


Contacts
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Contact: Rupesh Kotecha, M.D. (786) 596-2000 RupeshK@baptisthealth.net
Contact: Maria Carolina Avendaño (786) 527-8863 MariaAve@baptisthealth.net

Locations
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United States, Florida
Miami Cancer Institute
Miami, Florida, United States, 33176
Contact: Rupesh Kotecha, M.D.    786-596-2000    RupeshK@baptisthealth.net   
Contact: Maria Carolina Avendaño    (786) 527-8863    MariaAve@baptisthealth.net   
Sponsors and Collaborators
Baptist Health South Florida
Blue Earth Diagnostics
Investigators
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Principal Investigator: Rupesh Kotecha, M.D. Miami Cancer Institute at Baptist Health, Inc.
Additional Information:
Publications:

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Responsible Party: Baptist Health South Florida
ClinicalTrials.gov Identifier: NCT06048094    
Other Study ID Numbers: 2022-KOT-003
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: December 8, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Baptist Health South Florida:
stereotactic radiosurgery
18F-flucicloivine
PET imaging
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases