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Breast CancerPhase 1[18F]F-GLNNCT03863457

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

A Phase 1 study testing Fluoroglutamine [18F]F-GLN in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Fluoroglutamine [18F]F-GLN
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
5 Apr 2019to Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Erin Schubert contact

215-573-6569

erin.schubert@pennmedicine.upenn.edu

United States1 site, 1 recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Erin Schubert, 215-573-6569, erin.schubert@pennmedicine.upenn.edu

    Austin Pantel, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Breast Cancer
Being tested
Fluoroglutamine [18F]F-GLN
Keywords
breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluoroglutamine [18F]F-GLNDrug

    Also called [18F](2S, 4R)4-Fluoroglutamine ([18F]F-GLN)

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

Study groups in NCT03863457
Study groupRoleWhat they receive
UPTAKE OF [18F]F-GLN BY PET/CT IN BREAST CANCERExperimentalPilot 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.
Receives: Drug: Fluoroglutamine [18F]F-GLN

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 3 years

Secondary outcomes (5)

  1. 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.

    Measured: 3 years

  2. 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.

    Measured: 3 years

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

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

    Measured: 3 years

  4. 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.

    Measured: 3 years

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

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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2019
  2. Study start5 Apr 2019
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03863457
Sponsor's protocol ID
831804
Acronym
[18F]F-GLN
Status last verified
Jan 2026
First submitted
27 Feb 2019
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kwon D, Li EJ, Dulal C, Daube-Witherspoon M, Viswanath V, Young AJ, Damani RA, Hou-Liu J, McDonald ES, Mankoff DA, Karp JS, Pantel AR. Dual-Tracer Imaging on a Long-Axial-Field-of-View PET: A Proof-of-Principle Study with [18F]FGln and [18F]FDG. J Nucl Med. 2025 Jul 1;66(7):1149-1152. doi: 10.2967/jnumed.124.268831.

    PubMed 40506235

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fluoroglutamine [18F]F-GLN in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Erin Schubert (215-573-6569, erin.schubert@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kinetics and Biodistribution of [18F]F-GLN (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03863457, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

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