Recruiting
Phase 1

[18F] F-GLN

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT03863457

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fluoroglutamine [18F]F-GLN

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Study ID

NCT03863457

Start date

Apr 5, 2019

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Fluoroglutamine [18F]F-GLN

Evaluate the kinetics and biodistribution of \[18F\]F-GLN in primary and metastatic breast cancer.

Primary outcome measure

  • Kinetics and Biodistribution of [18F]F-GLN [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Erin Schubert

215-573-6569erin.schubert@pennmedicine.upenn.edu

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Erin Schubert

215-573-6569erin.schubert@pennmedicine.upenn.edu

Principal Investigator:

Austin Pantel, MD

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Keywords

  • breast cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-01-22.