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

Phase 1
Recruiting
Led By Austin Pantel, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Known or suspected primary or metastatic breast cancer
At least one lesion ≥ 1.5 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

[18F]F-GLN Trial Summary

This trial is for patients with breast cancer who have one lesion that is 1.5 cm in diameter or greater. Patients must be at least 18 years old to participate. up to 40 subjects will be observed in this study, with 10 estrogen-receptor-expressing (ER+) and 10 triple-negative breast cancers (TNBC) being given priority. [18F]F-GLN PET/CT will not be used to make treatment decisions, but to evaluate image quality and collect preliminary information on the uptake of [18F]F-GLN in breast cancer. The safety of [18F]F-GLN will

Who is the study for?
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.Check my eligibility
What is being tested?
[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.See study design
What are the potential side effects?
The safety profile of [18F]F-GLN will be monitored throughout the study; however, as it is a diagnostic agent rather than a therapeutic drug, fewer side effects are expected compared to treatment drugs. Any potential side effects from the injection or imaging process will be evaluated.

[18F]F-GLN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have or might have breast cancer that has spread.
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I have a tumor larger than 1.5 cm visible on an imaging test.
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I am 18 years old or older.

[18F]F-GLN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Kinetics and Biodistribution of [18F]F-GLN
Secondary outcome measures
Association of Uptake with [18F]F-GLN
Association with Tumor Markers and [18F]F-GLN
Change in Uptake of [18F]F-GLN After Therapy
+2 more

[18F]F-GLN Trial Design

1Treatment groups
Experimental Treatment
Group I: UPTAKE OF [18F]F-GLN BY PET/CT IN BREAST CANCERExperimental Treatment1 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.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,993 Previous Clinical Trials
42,875,533 Total Patients Enrolled
27 Trials studying Breast Cancer
26,330 Patients Enrolled for Breast Cancer
Austin Pantel, MDPrincipal InvestigatorInstructor of Radiology
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Fluoroglutamine [18F]F-GLN Clinical Trial Eligibility Overview. Trial Name: NCT03863457 — Phase 1
Breast Cancer Research Study Groups: UPTAKE OF [18F]F-GLN BY PET/CT IN BREAST CANCER
Breast Cancer Clinical Trial 2023: Fluoroglutamine [18F]F-GLN Highlights & Side Effects. Trial Name: NCT03863457 — Phase 1
Fluoroglutamine [18F]F-GLN 2023 Treatment Timeline for Medical Study. Trial Name: NCT03863457 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is enrollment increasing for this research project?

"Affirmative. The information displayed on clinicaltrials.gov confirms that this research is still recruiting participants, with a commencement date of April 5th 2019 and an amendment made July 5th 2022. 30 individuals will be needed to complete the study at one site."

Answered by AI

Is access to this trial currently available for individuals?

"Affirmative. Clinicaltrials.gov data proclaims that this research initiative, which was initially published on April 5th 2019, is still actively recruiting participants. Approximately 30 patients need to be enrolled from 1 trial centre."

Answered by AI

Has Fluoroglutamine [18F]F-GLN been officially acknowledged by the FDA?

"Due to the early stage of development, our team at Power has assigned Fluoroglutamine [18F]F-GLN a score of 1 on the safety scale. This is because Phase 1 trials typically have limited data available with regard to both efficacy and security."

Answered by AI
~4 spots leftby Dec 2024