Clinical trial NCT03863457: [18F] F-GLN by PET/CT in Breast Cancer
Official title: Pilot Study Evaluating the Uptake of [18F] F-GLN by PET/CT in Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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 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).

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.

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.

Eligibility criteria: Inclusion Criteria:

* Participants will be ≥ 18 years of age
* 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.
* 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.

Primary outcomes:
measure: Kinetics and Biodistribution of [18F]F-GLN
timeFrame: 3 years
Secondary outcomes:
measure: Incidence of Adverse Events (Safety and Tolerability)
timeFrame: 3 years
measure: Association of Uptake with [18F]F-GLN
timeFrame: 3 years
measure: Association with Tumor Markers and [18F]F-GLN
timeFrame: 3 years
measure: Metabolism of [18F]F-GLN
timeFrame: 3 years
measure: Change in Uptake of [18F]F-GLN After Therapy
timeFrame: 3 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Instructor of Radiology
name: Austin Pantel, MD
role: PRINCIPAL_INVESTIGATOR
References: