18F-fluoroestradiol (FES) PET/CT for Breast Cancer

Launched by HOAG MEMORIAL HOSPITAL PRESBYTERIAN · May 7, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging method called 18F-fluoroestradiol (FES) PET/CT to see if it can better detect breast cancer spread (metastases) in women whose cancers are positive for estrogen receptors (ER-positive). The standard imaging techniques currently used may not be the best for these patients, so researchers want to find out if FES PET/CT can provide more accurate information about the cancer's status.

To participate in this trial, women must be at least 18 years old and have a confirmed diagnosis of ER-positive breast cancer. They should also be planning to undergo standard imaging tests like CT scans or bone scans for either advanced or suspected recurrent breast cancer. Participants will need to provide written consent and be in good enough health to meet certain performance criteria. It's important to note that if a participant is currently using specific medications for breast cancer, they may need to stop using them for a certain amount of time before joining the study. This trial is currently active but not recruiting new participants.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Female ≥ 18 years of age.
• • 2. Histologically confirmed ER-positve breast cancer. Any pathology from a primary or metastatic breast cancer site demonstrating ER-positivity will be allowed.
• • 3. ECOG performance status 0 to 2
• • 4. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
• 5. Either:
• • 1. For cohort 1: Stage 2B-3C locally advanced disease and plan for CT/bone scan systemic staging or
• • 2. For cohort 2: Suspected recurrent disease and plan for CT/bone scan systemic staging
• Exclusion Criteria:
• • 1. Pregnant or breastfeeding
• • 2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
• • 3. Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
• • 4. Selective ER Modulators (SERMs) such as tamoxifen and Selective ER Degraders (SERDs) such as fulvestrant may reduce detection of ER-positive lesions by FES. Thus, exclusion criteria specify that patients must be withdrawn from Selective ER Modifiers for at least 8 weeks and withdrawn from Selective ER Degraders for for least 24 weeks prior to performance of the FES PET/CT.