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Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis (CONCORDANT)

Primary Purpose

Brain Metastases, Brain Cancer

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

18F-Fluciclovine

About this trial

This is an interventional diagnostic trial for Brain Metastases focused on measuring Brain metastases, Brain cancer, Stereotactic radiosurgery

Eligibility Criteria

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

Inclusion Criteria:

Age ≥ 18 years
Performance status, Eastern Cooperative Oncology Group (ECOG) 0-3
Radiographic diagnosis of brain metastasis
Patient planned for surgical intervention for at least 1 metastasis
Patient planned for postoperative SRS

Male or female patients of reproductive potential need to employ two highly effective and acceptable forms of 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 PET/CT. Highly effective and acceptable forms of contraception are:

Male condom plus spermicide
Cap plus spermicide
Diaphragm plus spermicide
Copper T
Progesterone T
Levonorgestrel-releasing intrauterine system (e.g., Mirena®)
Implants
Hormone shot or injection
Combined pill
Mini-pill
Patch

Postmenopausal people on the study (that will not need contraception) is defined as at least one of the following:

Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments
Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50
Radiation-induced oophorectomy with last menses > 1 year ago
Chemotherapy-induced menopause with >1 year interval since last menses
Surgical sterilization (bilateral oophorectomy or hysterectomy).

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)
Pregnant at the expected time of 18F-fluciclovine administration
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.

Sites / Locations

Miami Cancer Institute at Baptist Health South FloridaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET/CT, MRI

Arm Description

All patients will obtain an 18F-Fluciclovine PET/CT scan in addition to the planning MRI at the time of SRS treatment (approximately 2-4 weeks after resection). The value of 18F-Fluciclovine in addition to structural information from the MRI will be analyzed. Patients will continue to undergo 18F-Fluciclovine in addition to MRI during routine follow-up to determine the ability of 18F-Fluciclovine PET/CT to identify areas at risk for marginal failure, monitor resection beds for tumor control, identify patients at risk for disease recurrence, and detect patterns of failure.

Outcomes

Primary Outcome Measures

Change in conformality index of tumor target volume delineation

The tumor target volume (post-operative cavity and any residual or recurrent disease) will be delineated by post-operative MRI only. A second target volume will be generated using the 18F-Fluciclovine PET-defined volume. The conformality index is calculated by comparing the PET-defined tumor volume with MRI-defined tumor volume. Non-overlapping and overlapping regions regions of PET tumor volume and MRI tumor volume will be used to calculate conformality indices.

Change in PET scan standardized uptake value (SUV) parameters

The standardized uptake value (SUV) parameters of SUVpeak, SUVmean, and SUVmax will be measured to determine if they correlate tumor volume and can predict risk of recurrence.

Secondary Outcome Measures

Time to local failure

Each lesion will be followed from pre-treatment PET to local failure or re-retreatment; death; 12 months from pre-treatment PET; lost-to follow-up, discontinuation, or withdrawal; or end of study. In the event that a patient has more than one study eligible lesion, the patient will discontinue follow up after all lesions progress, or will be censored as above. Death will be treated as a competing event.

Full Information

NCT ID

NCT05554302

First Posted

September 16, 2022

Last Updated

February 8, 2023

Sponsor

Baptist Health South Florida

Collaborators

Blue Earth Diagnostics

1. Study Identification

Unique Protocol Identification Number

NCT05554302

Brief Title

Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis

Acronym

CONCORDANT

Official Title

Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 10, 2023 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

June 30, 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.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is for patients who have had surgery to remove brain metastasis and are planned to have stereotactic radiosurgery (SRS) after their brain surgery. It will be optional for patients to have a pre-surgery 18F-Fluciclovine PET/CT scan. The goal of the study is to determine whether a specific imaging agent, known as 18F-Fluciclovine, will help physicians evaluate the extent of surgery and determine if there is any visible tumor above what MRI alone can identify as well as improve the physicians' ability to detect recurring disease. This agent (18F-Fluciclovine) is investigational for the imaging of brain metastases.

6. Conditions and Keywords

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

Brain Metastases, Brain Cancer

Keywords

Brain metastases, Brain cancer, Stereotactic radiosurgery

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PET/CT, MRI

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

18F-Fluciclovine

Intervention Description

Patients will receive 5-mCi dose (+/- 20%) 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 conformality index of tumor target volume delineation

Description

Time Frame

3 weeks, 6 and 12 months

Title

Change in PET scan standardized uptake value (SUV) parameters

Description

The standardized uptake value (SUV) parameters of SUVpeak, SUVmean, and SUVmax will be measured to determine if they correlate tumor volume and can predict risk of recurrence.

Time Frame

3 weeks, 6 and 12 months

Secondary Outcome Measure Information:

Title

Time to local failure

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years Performance status, Eastern Cooperative Oncology Group (ECOG) 0-3 Radiographic diagnosis of brain metastasis Patient planned for surgical intervention for at least 1 metastasis Patient planned for postoperative SRS Male or female patients of reproductive potential need to employ two highly effective and acceptable forms of 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 PET/CT. Highly effective and acceptable forms of contraception are: Male condom plus spermicide Cap plus spermicide Diaphragm plus spermicide Copper T Progesterone T Levonorgestrel-releasing intrauterine system (e.g., Mirena®) Implants Hormone shot or injection Combined pill Mini-pill Patch Postmenopausal people on the study (that will not need contraception) is defined as at least one of the following: Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50 Radiation-induced oophorectomy with last menses > 1 year ago Chemotherapy-induced menopause with >1 year interval since last menses Surgical sterilization (bilateral oophorectomy or hysterectomy). 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) Pregnant at the expected time of 18F-fluciclovine administration 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.

Central Contact Person:

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

Rupesh R Kotecha, M.D.

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, M.D.

Organizational Affiliation

Miami Cancer Institute/Baptist Health South Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

Miami Cancer Institute at Baptist Health South Florida

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 Kotecha, MD

Phone

786-527-7642

RupeshK@baptisthealth.net

First Name & Middle Initial & Last Name & Degree

Rupesh Kotecha, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis

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