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Pilot Clinical Study to Evaluate Molecular Breast Imaging- Guidance for Sampling of Breast Abnormalities in Patients with Known or Suspected Breast Cancer

Overview

Información sobre este estudio

The purpose of this study is to confirm that the Stereo Navigator accessory to an MBI Imging system can successfully guide the sampling of abnormal MBI findings in patients with known or suspected breast cancer.

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:

  • Women aged 18 years or older.
  • If able to become pregnant, negative pregnancy test within 48 hours prior to MBI biopsy procedure.
  • Individuals who have previously (within the last 3 years) undergone an MBI study and were found to have at least one breast imaging finding on MBI that was subsequently shown (through additional imaging, biopsy or follow-up) to be benign or probably benign in nature.
  • Individuals who had recent conventional imaging work-up including either x-ray mammography, ultrasound, MBI, or MRI of the breast and are found to have at least one breast imaging finding for which biopsy is required or recommended, specifically:
    • Individuals who have a breast abnormality(ies) on imaging with mammography, ultrasound, MBI, or MRI (as per ACR BIRADS 3, or higher) and requiring imaging follow-up or biopsy confirmation.
  • Individuals who have agreed to participate in the study and who have signed study-specific informed consent.

Exclusion Criteria:

  • Women who are pregnant.
  • Women who are currently lactating or discontinued breastfeeding < 2 months prior to the study.
  • Age less than 18 years.
  • Women with breast implant(s) in the breast containing the lesion of interest.
  • Inability to provide informed consent.

Eligibility last updated 5/12/22. Questions regarding updates should be directed to the study team contact.

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 Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Katie Hunt, M.D.

Cerrado; inscripción por invitación

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El estudio no está abierto para todos los que cumplen con los criterios de elegibilidad, sino solamente para las personas que el equipo del estudio ha invitado a participar.

Contact information:

Michael O'Connor Ph.D.

(507) 284-9599

mkoconnor@mayo.edu

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20561152

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