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[18F] F-GLN by PET/CT in Breast Cancer
NCT03863457 · Abramson Cancer Center at Penn Medicine
In plain English
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Official title
Pilot Study Evaluating the Uptake of [18F] F-GLN by PET/CT in Breast Cancer
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.
Eligibility criteria
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.
Study design
Enrollment target: 40 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2019-04-05
Estimated completion: 2026-12
Last updated: 2026-01-22
Interventions
Drug: Fluoroglutamine [18F]F-GLN
Primary outcomes
- • Kinetics and Biodistribution of [18F]F-GLN (3 years)
Sponsor
Abramson Cancer Center at Penn Medicine · other
Contacts & investigators
ContactErin Schubert · contact · erin.schubert@pennmedicine.upenn.edu · 215-573-6569
InvestigatorAustin Pantel, MD · principal_investigator, Instructor of Radiology
All locations (1)
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States