Estrogen Receptor Expression in Breast Cancer - Assessed With Positron Emission Mammography
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-007764
NCT ID: NCT03266562
Sponsor Protocol Number: 16-007764
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
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 Criteria:
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?
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Tufia Haddad, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available