[18F] F-GLN by PET/CT in Breast Cancer ([18F]F-GLN)

Pilot Study Evaluating the Uptake of [18F] F-GLN by PET/CT in Breast Cancer

Patients with known or suspected primary or metastatic breast cancer with one lesion that is 1.0 cm in diameter or greater may be eligible for this study. Patients may participate in this study if they are at least 18 years of age. Up to 40 evaluable subjects will participate in a single imaging cohort. Patients will be stratified for analysis by breast cancer subtype with prioritization to recruit at least 10 estrogen-receptor-expressing (ER+) and 10 triple-negative breast cancers (TNBC). Participants may be treatment naïve or have received up to 3 weeks of treatment at the time of the [18F]F-Gln PET/CT scan.

This is an observational study; [18F]F-GLN PET/CT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the [18F]F-GLN PET/CT results, treatment decisions are made by the treating physicians based upon clinical criteria.

[18F]F-GLN PET/CT imaging sessions will include an injection of [18F]F-GLN. Metabolism data will be collected. Pilot data will be collected to evaluate image quality and collect preliminary information on the uptake of [18F]F-GLN in breast cancer. Uptake measures will be compared to tumor markers of glutamine metabolism, when tissue is available. The safety of [18F]F-GLN will also be evaluated in all subjects.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Fluoroglutamine [18F]F-GLN

Detailed Description

Up to 40 patients will undergo approximately 60 minutes of dynamic PET scanning followed by up to 2 static skull-base to mid-thigh scans post injection of [18F] (2S,4R)4-fluoroglutamine ([18F]F-GLN). A baseline FDG-PET/CT will also be performed, either as a routine clinical staging/re-staging scan or as a research scan. If performed as a research scan, the scan may include an optional dynamic imaging session. Some subjects, who undergo systemic therapy as part of their clinical treatment, may also undergo an optional second [18F]F-GLN PET/CT to collect pilot data on the changes in [18F]F-GLN uptake in response to therapy. Subjects who undergo a second [18F]F-GLN PET/CT may have a second FDG-PET/CT, again either as a standard-of-care restaging study or as an optional research scan. The timing of the optional second PET scans will vary depending on the type of treatment the subject is receiving. If the subject moves during their scans, a low-dose CT attenuation may be repeated following the dynamic scan at the PI's discretion.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Erin Schubert; Phone Number: 215-573-6569; Email: Erin.schubert@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Principal Investigator: Austin Pantel, MD
      • Contact: Erin Schubert; Phone Number: 215-573-6569; Email: Erin.schubert@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants will be ≥ 18 years of age
• Known or suspected primary or metastatic breast cancer.
• At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. CT, MRI, mammogram, ultrasound, FDG-PET/CT). Only one type of imaging is required to show a lesion.
• Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

• Females who are pregnant or breast feeding at the time of screening; a urine pregnancy test will be performed in women of child-bearing potential at screening.
• Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
• Any current medical condition, illness, or disorder, as assessed by medical record review and/or self-reported, that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UPTAKE OF [18F]F-GLN BY PET/CT IN BREAST CANCER; Pilot data will be collected to evaluate image quality and collect preliminary information on the uptake of [18F]F-Gln in breast cancer. Uptake measures will be compared to tumor markers of glutamine metabolism, when tissue is available. The safety of [18F]F-Gln will also be evaluated in all subjects.	Drug: Fluoroglutamine [18F]F-GLN; Evaluate the kinetics and biodistribution of [18F]F-GLN in primary and metastatic breast cancer.; Other Names: [18F](2S, 4R)4-Fluoroglutamine ([18F]F-GLN)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinetics and Biodistribution of [18F]F-GLN	Evaluate the biodistribution of [18F]F-GLN by measuring organ and whole body dosimetry.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events (Safety and Tolerability)	Evaluate the safety of [18F]F-GLN. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.	3 years
Association of Uptake with [18F]F-GLN	Assess the correlation of [18F]F-GLN with pathologic sub-types of breast cancer using standard pathology results, ER, PR, HER2.	3 years
Association with Tumor Markers and [18F]F-GLN	Correlate uptake of [18F]F-GLN with pathologic measurement of glutamine metabolism in tissue.	3 years
Metabolism of [18F]F-GLN	Measure the biometabolites in patient blood over time, following injection of [18F]F-GLN to determine the rate at which [18F]F-GLN is metabolized.	3 years
Change in Uptake of [18F]F-GLN After Therapy	Evaluate change in [18F]F-GLN uptake measures after therapy compared to pre-treatment baseline.	3 years

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Austin Pantel, MD, Instructor of Radiology

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 27, 2019
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 831804

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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