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NCT Number: NCT03863457

[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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Austin Pantel, MD

PRINCIPAL_INVESTIGATOR

Erin Schubert

CONTACT

[email protected]

215-573-6569

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluoroglutamine [18F]F-GLN

Drug

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)

Primary outcomes

  1. Kinetics and Biodistribution of [18F]F-GLN

    Time frame: 3 years

    Evaluate the biodistribution of [18F]F-GLN by measuring organ and whole body dosimetry.

Secondary outcomes

  1. Incidence of Adverse Events (Safety and Tolerability)

    Time frame: 3 years

    Evaluate the safety of [18F]F-GLN. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

  2. Association of Uptake with [18F]F-GLN

    Time frame: 3 years

    Assess the correlation of [18F]F-GLN with pathologic sub-types of breast cancer using standard pathology results, ER, PR, HER2.

  3. Association with Tumor Markers and [18F]F-GLN

    Time frame: 3 years

    Correlate uptake of [18F]F-GLN with pathologic measurement of glutamine metabolism in tissue.

  4. Metabolism of [18F]F-GLN

    Time frame: 3 years

    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.

  5. Change in Uptake of [18F]F-GLN After Therapy

    Time frame: 3 years

    Evaluate change in [18F]F-GLN uptake measures after therapy compared to pre-treatment baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Schubert

CONTACT

[email protected]

215-573-6569

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

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

Acronym: [18F]F-GLN

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2019
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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