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

Primary Purpose

Brain Metastases, Adult, Brain Metastases, Brain Cancer

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

18F fluciclovine

About this trial

This is an interventional prevention trial for Brain Metastases, Adult focused on measuring brain, brain metastases, brain metastases, adult, brain cancer, Stereotactic Radiosurgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female, age ≥18 years
Performance status, Eastern Cooperative Oncology Group 0-2
Confirmed diagnosis of brain metastases with at least one untreated lesion >2 cm in maximum diameter
Plan for SSRS per the treating team
For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required
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:

Prior anaphylactic reaction to 18F-fluciclovine
Evidence of leptomeningeal disease
Prior whole-brain radiation therapy
Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)
Females pregnant at the expected time of 18F-fluciclovine administration
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
Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent

Sites / Locations

Miami Cancer Institute at Baptist Health, Inc
Miami Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PET/CT, MRI

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in sensitivity for PET/CT

Calculate the sensitivity of pre-treatment 18F-fluciclovine PET/CT to identify brain metastases >2 cm treated with SSRS.

Change in sensitivity for MRI

To calculate the sensitivity of pre-treatment contrast-enhanced MRI.

Change in the standardized uptake value (SUV) parameters

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

Compare change of SUV metrics of 18F-fluciclovine PET

To calculate the pre-, interim-, and post-treatment SUV metrics of 18F-fluciclovine PET uptake

Compare change of SUV metrics of contrast-enhanced MRI

To calculate the percent change in lesion volume on contrast-enhanced MRI (∆MRIvolume).

Full Information

NCT ID

NCT04689048

First Posted

December 11, 2020

Last Updated

November 18, 2022

Sponsor

Baptist Health South Florida

Collaborators

Blue Earth Diagnostics

1. Study Identification

Unique Protocol Identification Number

NCT04689048

Brief Title

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

Official Title

Characterization of Large Brain Metastases With 18F-Fluciclovine PET/CT Treated With Staged Stereotactic Radiosurgery

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 4, 2022 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Baptist Health South Florida

Collaborators

Blue Earth Diagnostics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Metastases, Adult, Brain Metastases, Brain Cancer

Keywords

brain, brain metastases, brain metastases, adult, brain cancer, Stereotactic Radiosurgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PET/CT, MRI

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

18F fluciclovine

Other Intervention Name(s)

Axumin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in sensitivity for PET/CT

Description

Calculate the sensitivity of pre-treatment 18F-fluciclovine PET/CT to identify brain metastases >2 cm treated with SSRS.

Time Frame

through study completion, an average of 1 year

Title

Change in sensitivity for MRI

Description

To calculate the sensitivity of pre-treatment contrast-enhanced MRI.

Time Frame

through study completion, an average of 1 year

Title

Change in the standardized uptake value (SUV) parameters

Description

To identify a change in the standardized uptake value (SUV) parameters (SUVpeak, SUVmean, and SUVmax) for the 18F-fluciclovine PET/CT scans.

Time Frame

through study completion, an average of 1 year

Secondary Outcome Measure Information:

Title

Compare change of SUV metrics of 18F-fluciclovine PET

Description

To calculate the pre-, interim-, and post-treatment SUV metrics of 18F-fluciclovine PET uptake

Time Frame

baseline

Title

Compare change of SUV metrics of contrast-enhanced MRI

Description

To calculate the percent change in lesion volume on contrast-enhanced MRI (∆MRIvolume).

Time Frame

baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, age ≥18 years Performance status, Eastern Cooperative Oncology Group 0-2 Confirmed diagnosis of brain metastases with at least one untreated lesion >2 cm in maximum diameter Plan for SSRS per the treating team For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required 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: Prior anaphylactic reaction to 18F-fluciclovine Evidence of leptomeningeal disease Prior whole-brain radiation therapy Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker) Females pregnant at the expected time of 18F-fluciclovine administration 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 Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rupesh C Kotecha, MD

Phone

17865962000

rupeshk@baptisthealth.net

First Name & Middle Initial & Last Name or Official Title & Degree

Maria C Avendano

Phone

17865962000

mariaave@baptisthealth.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rupesh R Kotecha, MD

Organizational Affiliation

Miami Cancer Institute (MCI) at Baptist Health, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Miami Cancer Institute at Baptist Health, Inc

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rupesh R Kotecha

Phone

786-596-2000

RupeshK@baptisthealth.net

First Name & Middle Initial & Last Name & Degree

Rupesh R Kotecha, MD

Facility Name

Miami Cancer Institute

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rupesh C Kotecha

Phone

786-596-2000

rupeshk@baptisthealth.net

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34081125

Citation

Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available.

Results Reference

derived

Links:

URL

http://baptisthealth.net/cancer-care/home

Description

Miami Cancer Institute website

Learn more about this trial

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

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