Status:
WITHDRAWN
Estrogen Receptor Expression in Breast Cancer - Assessed With Positron Emission Mammography
Lead Sponsor:
Mayo Clinic
Conditions:
Breast Neoplasm
Eligibility:
FEMALE
40-90 years
Phase:
NA
Brief Summary
The primary objective of this study is to determine the correlation between the distribution of F-18 FES within ER+ breast tumors as seen on Positron Emission Mammography (PEM) images of the breast, a...
Detailed Description
This pilot study will recruit up to 20 patients with newly diagnosed ER+ breast cancer who have recently undergone or are scheduled to undergo a clinically-indicated breast MRI examination and are sch...
Eligibility Criteria
Inclusion
- Eligible patients will be offered enrollment if the time interval between initial diagnosis and surgery allows for performance of the PEM studies with both F18 FDG and F-18 FES, and they meet the following criteria:
- Postmenopausal women, as defined by
- Lack of menstrual periods for ≥ 12 months
- For women with prior hysterectomy and age \< 60, a serum FSH level within the postmenopausal range
- Histologic proof of invasive breast carcinoma that is ER positive per ASCO/CAP guidelines (staining in ≥ 1% of cells by immunohistochemistry)
- Extent of disease confirmed, or to be confirmed, on a clinical contrast-enhanced breast MRI examination
- Minimum size criteria for index cancer of 10 mm as measured on mammogram, ultrasound, or MRI.
- Planned surgical excision of the breast cancer at Mayo Clinic, Rochester
Exclusion
- Patients are excluded if they meet any of the following criteria:
- Premenopausal
- Unable to undergo PEM scanning (weight limit of 300 lbs. on PEM system or inability to lie prone for 30 minutes)
- Total serum bilirubin \> 1.5 x upper limit of normal (abnormal hepatic metabolism may interfere with FES hepatic excretion),
- Serum creatinine \> 1.5 x upper limit of normal
- Patients who have received, are currently receiving, or planning to receive neoadjuvant systemic therapy prior to surgical excision
- Patients who will undergo core needle biopsy of the breast or axilla between the breast MRI and investigational PEM studies. NOTE: Axillary ultrasound with or without fine needle aspiration of an axillary mass or lymph node is allowed.
- Patients with breast implants?
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03266562
Start Date
September 1 2018
End Date
April 30 2019
Last Update
May 9 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Rochester, Minnesota, United States, 55905