[18F]Fluoroestradiol-PET/CT Imaging of Invasive Lobular Carcinoma

• Status: Completed
• Trial end date: 2021-08-04
• Target enrollment: 0
• Participant gender: All

Summary

FES PET/CT imaging for invasive lobular cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah

Criteria

Inclusion Criteria:

• Adults aged 18 years or greater

• All patients or legal guardians are willing and able to sign a written informed consent and HIPAA authorization in accordance with local and institutional guidelines.

• Histologically confirmed invasive lobular carcinoma within the past 12 weeks confirmed from biopsy of primary tumor or metastasis.

• Patient is willing to have their clinical records reviewed for at least 24 months after enrollment.

Exclusion Criteria:

• Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.

• Patients who require monitored anesthesia for PET/CT scanning.

• Patients who are too claustrophobic to undergo PET/CT scanning.

• Pregnancy or current breast feeding.

• Any patient that is medically unstable defined as patient requiring inpatient hospitalization or needing evaluation at an acute care or urgent care facility at time of imaging.

• Patients undergoing treatment with estrogen receptor agonists (such as fulvestrant and tamoxifen) within 5 weeks of the FES-PET/CT scan. (Note that aromatase inhibitors and luteinizing hormone-releasing hormone agonists do not affect ER expression, or binding of FES to ER, and do not need to be discontinued or considered for inclusion or exclusion of patients).

• Patient who have had the site(s) of biopsy proven invasive lobular carcinoma surgically resected.