Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSUE)

NCT04410367 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BED-FLC-219
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 9

Brief Summary

An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy

Conditions

Brain Metastases

Keywords

Recurrent Brain Metastases; Diagnostic; Positron Emission Tomography (PET) Scan

Outcome Measures

Primary Outcomes (2)

• Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds

  Sensitivity is calculated as % of participants with positive histopathology who are classified as positive on their 18F fluciclovine PET (i.e. true positive). Each participant had one lesion, therefore results are representative of both subject and lesion level sensitivity. Three readers evaluated the PET scans to classify 18F fluciclovine uptake in study lesions according to 4 incremental categories: absent, mild, moderate or marked. Three different thresholds of 18F fluciclovine uptake were then applied to calculate the sensitivity: Mild or Higher Uptake, Moderate or Higher Uptake, Marked Uptake. As an example, for calculating sensitivity based on the threshold of Mild or Higher Uptake, all participants with positive histopathology, classified by a reader as having mild, moderate or marked 18F fluciclovine uptake, would be categorized as true positive. This calculation was then repeated on the other two threshold categories, to produce sensitivities at different thresholds.

  60 days

• Specificity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds

  Specificity is calculated as the % of participants with negative histopathology who are classified as negative on their 18F fluciclovine PET (i.e. true negative). Each participant had 1 lesion, therefore results are representative of both subject and lesion level specificity. 3 readers evaluated the PET scans to classify 18F fluciclovine uptake in study lesions according to 4 incremental categories: absent, mild, moderate or marked. 3 different thresholds of uptake were then applied to calculate the specificity: Mild or Higher Uptake, Moderate or Higher Uptake, Marked Uptake. Example, for calculating specificity based on the threshold of Moderate or Higher Uptake, all participants with negative histopath, classified by a reader as having absent or mild uptake (i.e. not classified by a reader as having moderate or marked uptake), would be categorized as true negative. This calculation was repeated on the other 2 threshold categories, to produce specificities at different thresholds

  60 days

Secondary Outcomes (3)

• Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake

  60 days

• Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake.

  60 days

• Treatment-emergent Adverse Events

  From the time of administration of 18F fluciclovine until 1 day post-18F-fluciclovine administration.

Study Arms (1)

Patients

EXPERIMENTAL

Single intravenous administration of 18F fluciclovine for PET Scan

Drug: 18F fluciclovine

Interventions

18F fluciclovine DRUG

18F fluciclovine injection, 185 MegaBecquerel (MBq) (5 Millicurie (mCi)) ± 20%, delivered as an intravenous bolus

Also known as: Axumin

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Previous history of solid tumor brain metastasis of any origin
• Histopathological confirmation of the primary solid tumor or a metastatic site
• Previous radiation therapy of brain metastatic lesion(s)
• A reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis
• Patient requires further confirmatory diagnostic procedures to confirm brain MRI findings and is planned for craniotomy

You may not qualify if:

• \. Patients with a history of active hematological malignancy

Sponsors & Collaborators

• Blue Earth Diagnostics: lead
• Precision For Medicine: collaborator

Study Sites (9)

John Wayne Cancer Institute at Providence St. John's Health Center

Santa Monica, California, 90404, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06519, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70131, United States

Location

Washington University School of Medicine Center for Clinical Imaging Research

St Louis, Missouri, 63110, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

University Hospital Cleveland

Cleveland, Ohio, 44106, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Center for Quantitative Cancer Imaging at Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• 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.

  PMID: 34081125 DERIVED

MeSH Terms

Conditions

Brain Neoplasms; Disease

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Blue Earth Diagnostics, Ltd.

contact@blueearthDx.com

+44 (0)1865 784 186

Study Officials

• Eugene Teoh, MD

  Blue Earth Diagnostics

  STUDY DIRECTOR

• Rupesh Kotecha, MD

  Miami Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Positron Emission Tomography (PET) Imaging study

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 1, 2020
• Study Start: August 31, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 20, 2025
• Results First Posted: August 1, 2023

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)