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Evaluation of 18F-fluciclovine (FACBC) PET/MR Uptake in Participants With Glioma (FACBC)

Primary Purpose

Glioma

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-fluciclovine
Sponsored by
James Mountz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Glioma

Eligibility Criteria

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

Inclusion Criteria:

  • 1. Age ≥ 18 years old.

    2. Been previously diagnosed by resection or biopsy with grade 3 or 4 glioma.

    3. Agree to use adequate contraception as indicated in this protocol.

    4. Consent to PET scanning and receipt of one injection of 18F-fluciclovine.

    5. Able to comply with study procedures.

    6. Able to give written consent.

    7. Subject has had a standard of care, diagnostic MRI study which was indeterminate due to the inability to differentiate pseudoprogression versus tumor progression.

Exclusion Criteria:

  • 1. Are a pregnant or breastfeeding female.

    2. Are participating in a clinical trial of another unlicensed product.

    3. Are undergoing 18F-fluciclovine PET for reason(s) other than newly diagnosed or recurrent glioma.

    4. Have a hypersensitivity to 18F-fluciclovine.

    5. Have acute renal failure or moderate/severe renal impairment, according to local clinical guidelines.

    6. Have a non-MRI compatible implantable device or another contraindication for MRI scan.

    7. Are deemed ineligible to participate for other reasons by an investigator.

Sites / Locations

  • UPMC Hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants with Glioma

Arm Description

[F18]fluciclovine will be utilized to assess tumor viability compared with F-18 FDG PET or diagnostic MRI.

Outcomes

Primary Outcome Measures

To assess the ability of [F-18]fluciclovine to differentiate radionecrosis (pseudoprogression) from tumor recurrence (progression) in patients after therapy, at imaging time points within the 12 week interval post chemoradiation.
To assess the ability of [F-18]fluciclovine to differentiate pseudoprogression from progression as compared to F-18 FDG, regions of interest will be drawn around MRI anatomically defined enhancing tumor regions and translated to both the F-18 FDG and F-18 fluciclovine PET scans to obtain SUV for each tracer. The SUV values will be correlated with the diagnosis of pseudoprogression versus tumor progression as determined by the regression of lesion enhancement on subsequent standard clinical follow up MRI imaging, as described in the protocol.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2019
Last Updated
December 5, 2022
Sponsor
James Mountz
Collaborators
Blue Earth Diagnostics
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1. Study Identification

Unique Protocol Identification Number
NCT04114370
Brief Title
Evaluation of 18F-fluciclovine (FACBC) PET/MR Uptake in Participants With Glioma
Acronym
FACBC
Official Title
Evaluation of 18F-fluciclovine (FACBC) PET/MR Uptake in Participants With Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 22, 2019 (Actual)
Primary Completion Date
May 18, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
James Mountz
Collaborators
Blue Earth Diagnostics

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a pilot study to assess the ability of [F-18]fluciclovine to differentiate pseudoprogression from progression in participants after therapy, at imaging time points within the 12 week interval post chemoradiation. [F-18]fluciclovine. PET will be obtained at the time point in the 12 week interval in which MRI demonstrates increase in enhancing volume with the differential diagnosis of pseudoprogression versus tumor progression. At the same time point (at least 6 hours after [F-18]fluciclovine or up to 3 days) F-18 FDG will also be performed consistent with standard clinical practice. The verification of pseudoprogression versus tumor progression will be determined by the regression of enhancing lesion on subsequent MRI imaging obtained as part of standard care.
Detailed Description
In this pilot study the investigators propose to image 10 participants who have been previously diagnosed by resection or biopsy with grade 3 or 4 glioma. All glioma cases undergoing resection at UPMC are evaluated by immunohistochemistry for mutations in p53, nuclear localization of ATRX, and the presence of IDH1R132H mutation as part of standard neuropathologic integrated diagnosis using the WHO 2016 diagnostic criteria. All glioma cases resected at UPMC undergo genetic profiling using next generation sequencing. MRI imaging will be obtained as part of standard clinical care. The MRI sequences include T1 pre and post contrast, T2 FLAIR, DWI, ADC and perfusion sequences using the imaging algorithm for evaluating treatment response in glioma treatment trials. Radiogenomic analysis will be performed using the MRI imaging sequences obtained as standard clinical care.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants with Glioma
Arm Type
Experimental
Arm Description
[F18]fluciclovine will be utilized to assess tumor viability compared with F-18 FDG PET or diagnostic MRI.
Intervention Type
Drug
Intervention Name(s)
18F-fluciclovine
Intervention Description
Prior to beginning PET imaging, 18F-fluciclovine will be administered as an intravenous bolus injection followed by a 10mL saline flush. 18F-fluciclovine will be injected through a cannula (or indwelling catheter) in an antecubital vein or another vein that will provide access. The administration site will be evaluated pre- and post-administration for any reaction. Documentation of administration to a participant will be recorded or as part of the scan upload, including date, prescription number, dose activity (as measured at time of administration), total volume, and start/stop time of administration.
Primary Outcome Measure Information:
Title
To assess the ability of [F-18]fluciclovine to differentiate radionecrosis (pseudoprogression) from tumor recurrence (progression) in patients after therapy, at imaging time points within the 12 week interval post chemoradiation.
Description
To assess the ability of [F-18]fluciclovine to differentiate pseudoprogression from progression as compared to F-18 FDG, regions of interest will be drawn around MRI anatomically defined enhancing tumor regions and translated to both the F-18 FDG and F-18 fluciclovine PET scans to obtain SUV for each tracer. The SUV values will be correlated with the diagnosis of pseudoprogression versus tumor progression as determined by the regression of lesion enhancement on subsequent standard clinical follow up MRI imaging, as described in the protocol.
Time Frame
90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years old. 2. Been previously diagnosed by resection or biopsy with grade 3 or 4 glioma. 3. Agree to use adequate contraception as indicated in this protocol. 4. Consent to PET scanning and receipt of one injection of 18F-fluciclovine. 5. Able to comply with study procedures. 6. Able to give written consent. 7. Subject has had a standard of care, diagnostic MRI study which was indeterminate due to the inability to differentiate pseudoprogression versus tumor progression. Exclusion Criteria: 1. Are a pregnant or breastfeeding female. 2. Are participating in a clinical trial of another unlicensed product. 3. Are undergoing 18F-fluciclovine PET for reason(s) other than newly diagnosed or recurrent glioma. 4. Have a hypersensitivity to 18F-fluciclovine. 5. Have acute renal failure or moderate/severe renal impairment, according to local clinical guidelines. 6. Have a non-MRI compatible implantable device or another contraindication for MRI scan. 7. Are deemed ineligible to participate for other reasons by an investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James M Mountz, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Hospitals
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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

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Evaluation of 18F-fluciclovine (FACBC) PET/MR Uptake in Participants With Glioma

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