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Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04689048
Recruitment Status : Not yet recruiting
First Posted : December 30, 2020
Last Update Posted : November 1, 2021
Blue Earth Diagnostics
Information provided by (Responsible Party):
Baptist Health South Florida

Brief Summary:
The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer. This study is being done to determine whether the use of a new imaging agent, 18F-fluciclovine, is able to detect which patients are responding to radiation therapy. In addition, this study will look at the changes of the treated brain metastases using this imaging agent over time.

Condition or disease Intervention/treatment Phase
Brain Metastases, Adult Brain Metastases Brain Cancer Drug: 18F fluciclovine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a prospective, single-site, single-arm, phase 1 proof-of-concept study to assess the potential clinical utility of 18F-fluciclovine PET/CT as a functional integral biomarker for patients with large brain metastases (>2 cm) treated with Staged Stereotactic Radiosurgery (SSRS).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Characterization of Large Brain Metastases With 18F-Fluciclovine PET/CT Treated With Staged Stereotactic Radiosurgery
Estimated Study Start Date : December 1, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
In total, three 18F-fluciclovine PET/CT brain scans (pre-, interim-, and post-treatment) will be performed according to the study calendar. Generic name is Axumin and will be administered as an intravenous bolus. May administer diluted or undiluted. The maximum volume of undiluted 18F-fluciclovine is 5 mL. After administration, flush with normal saline to ensure full delivery of the dose.
Drug: 18F fluciclovine
Patients will receive a standard 5 millicuries dose of 18F-fluciclovine intravenously as a bolus injection. They will be required to fast for at least four hours prior to 18F-fluciclovine injection. Patients will be positioned for PET/CT brain imaging and will be injected with 18F-fluciclovine 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 Name: Axumin

Primary Outcome Measures :
  1. Change in sensitivity for PET/CT [ Time Frame: through study completion, an average of 1 year ]
    Calculate the sensitivity of pre-treatment 18F-fluciclovine PET/CT to identify brain metastases >2 cm treated with SSRS.

  2. Change in sensitivity for MRI [ Time Frame: through study completion, an average of 1 year ]
    To calculate the sensitivity of pre-treatment contrast-enhanced MRI.

  3. Change in the standardized uptake value (SUV) parameters [ Time Frame: through study completion, an average of 1 year ]
    To identify a change in the standardized uptake value (SUV) parameters (SUVpeak, SUVmean, and SUVmax) for the 18F-fluciclovine PET/CT scans.

Secondary Outcome Measures :
  1. Compare change of SUV metrics of 18F-fluciclovine PET [ Time Frame: baseline ]
    To calculate the pre-, interim-, and post-treatment SUV metrics of 18F-fluciclovine PET uptake

  2. Compare change of SUV metrics of contrast-enhanced MRI [ Time Frame: baseline ]
    To calculate the percent change in lesion volume on contrast-enhanced MRI (∆MRIvolume).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. Male or female, age ≥18 years
  2. Performance status, Eastern Cooperative Oncology Group 0-2
  3. Confirmed diagnosis of brain metastases with at least one untreated lesion >2 cm in maximum diameter
  4. Plan for SSRS per the treating team
  5. For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required
  6. For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 1 week after post-treatment 18F-fluciclovine positron emission tomography/computerized tomography

Exclusion Criteria:

  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. Females pregnant at the expected time of 18F-fluciclovine administration
  6. Females who are 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
  7. Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent

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 identifier (NCT number): NCT04689048

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Contact: Rupesh R Kotecha, MD 786-596-2000

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United States, Florida
Miami Cancer Institute at Baptist Health, Inc
Miami, Florida, United States, 33176
Contact: Rupesh R Kotecha    786-596-2000   
Principal Investigator: Rupesh R Kotecha, MD         
Sponsors and Collaborators
Baptist Health South Florida
Blue Earth Diagnostics
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Principal Investigator: Rupesh R Kotecha, MD Miami Cancer Institute (MCI) at Baptist Health, Inc.
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Baptist Health South Florida Identifier: NCT04689048    
Other Study ID Numbers: 2019-KOT-001
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021
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.: No
Keywords provided by Baptist Health South Florida:
brain metastases
brain metastases, adult
brain cancer
Stereotactic Radiosurgery
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases