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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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?

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Tufia Haddad, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20398663

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