Estrogen Receptor Expression in Breast Cancer - Assessed With Positron Emission Mammography
Withdrawn before enrolling · Not applicable
Conditions studied: Breast Neoplasm
In brief
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, and the distribution of cells stained ER+ within the tumor by immunohistochemistry (IHC) measurements at surgical pathology. The secondary aim is to determine if the correlation (or lack of) between F-18 FES uptake and F-18 FDG uptake as imaged by PEM, is an accurate representation of the heterogeneity of ER expression in the tumor.
Key facts
- Study ID
- NCT03266562
- Run by
- Mayo Clinic
- People needed
- 0
- Starts
- 2018-09-01
- Expected to finish
- 2019-04-30
- Last updated by the study team
- 2019-05-09
Who can join
Age: 40 and older, up to 90. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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?
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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