[18F] F-GLN by PET/CT in Breast Cancer ([18F] F-GLN)
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|ClinicalTrials.gov Identifier: NCT03863457|
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : April 9, 2019
Patients with known or suspected primary or metastatic breast cancer with one lesion that is 1.5 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 30 evaluable subjects will participate in a single imaging cohort. Patients will be stratified by breast cancer subtype with prioritization to recruit at least 10 estrogen-receptor-expressing (ER+) and 10 triple-negative breast cancers (TNBC).
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Drug: Fluoroglutamine [18F]F-GLN|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Pilot Study Evaluating the Uptake of [18F] F-GLN by PET/CT in Breast Cancer|
|Actual Study Start Date :||April 5, 2019|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||December 2024|
- Drug: Fluoroglutamine [18F]F-GLN
Evaluate the kinetics and biodistribution of [18F]F-GLN in primary and metastatic breast cancer.Other Name: [18F](2S, 4R)4-Fluoroglutamine ([18F]F-GLN)
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863457
|Contact: Theresa E Berger, MBEemail@example.com|
|Contact: Erin Schubertfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Theresa E Berger, MBE 215-746-2813 email@example.com|
|Contact: Erin Schubert 215-573-6569 firstname.lastname@example.org|
|Principal Investigator: Austin Pantel, MD|
|Principal Investigator:||Austin Pantel, MD||Instructor of Radiology|