Estrogen Receptor Expression in Breast Cancer - Assessed With Positron Emission Mammography

NCT03266562 | Withdrawn FDA Device

• 1 other identifier: 16-007764
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Breast Neoplasm

Keywords

Positron Emission Mammography

Outcome Measures

Primary Outcomes (1)

• correlation of FES and estrogen receptors

  The primary objective of this study is to determine the correlation between F-18 FES uptake on PEM, and distribution of ER+ tissue on pathology

  1 year

Secondary Outcomes (1)

• correlation of FES and FDG in breast tumors

  1 year

Study Arms (1)

FES vs FDG

OTHER

All patients will undergo two PEM studies, one with F-18 FDG and the second with F-18 FES. Co-registration of the PEM images from F-18 FDG and F-18 FES will be used to assess the heterogeneity of uptake of the F-18 FES relative to that of F-18 FDG. Heterogeneity of ER expression in the tumor will be determined by immunohistochemistry on the pathologic tissue

Diagnostic Test: F-18 FES; Diagnostic Test: F-18 FDG

Interventions

F-18 FES DIAGNOSTIC_TEST

Evaluate uptake of F-18 FES in breast tissue

FES vs FDG

F-18 FDG DIAGNOSTIC_TEST

Evaluate uptake of F-18 FDG in breast tissue

FES vs FDG

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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?

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michael K O'Connor, Ph.D

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: consultant on medical physics

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: August 30, 2017
• Study Start: September 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: May 9, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)