Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT03863457

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

Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-01-22

40

Participants Needed

1

Research Sites

399 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants will be 18 years of age or older
  • Known or suspected primary or metastatic breast cancer
  • At least one lesion 1.0 cm or larger visible on standard imaging (CT, MRI, mammogram, ultrasound, or FDG-PET/CT)
  • Willing to provide informed consent and participate according to institutional and federal guidelines
Not Eligible

You will not qualify if you...

  • Females who are pregnant or breastfeeding at screening; urine pregnancy test required for women of child-bearing potential
  • Unable to tolerate imaging procedures as judged by investigator or treating physician
  • Any medical condition or disorder that may compromise safety or successful study participation as assessed by physician

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

E

Erin Schubert

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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