Pilot Study Evaluating the Uptake of [18F] F-GLN by PET/CT in Breast Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Erin Schubert
erin.schubert@pennmedicine.upenn.edu
215-573-6569
Time Frame
Start Date: 2019-04-05
Estimated Completion Date: 2026-12
Participants
Target number of participants: 40
Treatments
Experimental: UPTAKE OF [18F]F-GLN BY PET/CT IN BREAST CANCER
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.
Related Therapeutic Areas
Sponsors
Leads: Abramson Cancer Center at Penn Medicine

This content was sourced from clinicaltrials.gov