[18F] F-GLN PET/CT Imaging for Breast Cancer

([18F]F-GLN Trial)

Overseen By Erin Schubert

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Pregnancy, Breastfeeding, Imaging intolerance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial uses a special scan to see how a substance is absorbed by breast cancer cells in adults with significant lesions. The scan helps doctors understand the activity of the cancer by showing how much of the substance the cancer cells take up.

Who Is on the Research Team?

Austin Pantel, MD

Principal Investigator

Instructor of Radiology

Are You a Good Fit for This Trial?

This trial is for adults with breast cancer who have at least one tumor that's 1.5 cm or larger, visible on standard imaging like CT, MRI, mammograms, etc. It's open to those with primary or metastatic breast cancer and requires participants to consent to its investigational nature. Pregnant or breastfeeding women and individuals unable to tolerate imaging procedures are excluded.

Inclusion Criteria

I have or might have breast cancer that has spread.

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

I have a tumor larger than 1.5 cm visible on an imaging test.

Exclusion Criteria

I don't have any health issues that a doctor thinks would make the study unsafe for me.

I am not pregnant or breastfeeding.

Inability to tolerate imaging procedures in the opinion of an investigator or treating physician

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo dynamic PET scanning and static scans post injection of [18F]F-GLN. Baseline FDG-PET/CT is also performed.

1 day

1 visit (in-person)

Optional Second Imaging

Some subjects may undergo a second [18F]F-GLN PET/CT and FDG-PET/CT to collect data on changes in uptake in response to therapy.

Varies

Follow-up

Participants are monitored for safety and effectiveness after imaging sessions.

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Fluoroglutamine [18F]F-GLN

Trial Overview [18F]F-GLN PET/CT scans are being tested in this observational study of up to 40 patients with different types of breast cancer. The scan involves an injection of [18F]F-GLN and aims to collect metabolism data and assess the uptake related to glutamine metabolism in tumors when tissue samples are available.

How Is the Trial Designed?

Group I: UPTAKE OF [18F]F-GLN BY PET/CT IN BREAST CANCER Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+