Molecular Breast Imaging: A Novel Technology for Detection of Malignant Breast Lesions

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01004666
First received: October 29, 2009
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

Detection of breast cancer as early as possible is an ongoing imaging challenge.The purpose of the current study is to assess the clinical performance of the new scintigraphic technology, a dedicated breast gamma camera composed by the new generation of CZT detectors,for assessment of breast pathology specifically in women where current imaging techniques, mainly mammography are suboptimal. These cohort are patients with dense breast tissue and patients who are at high risk for breast cancer by a combination of other metrics, including family history and genetic testing. BRCA (breast cancer susceptibility gene), is particularly a relevant health problem among Ashkenazi Jews in Israel.


Condition
Small Breast Lesions
Dense Breast Tissue
Discrepancy With Clinical Examination
Equivocal Mammographic, Sonographic or MRI Lesion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Breast Imaging: A Novel Technology for Detection of Malignant Breast Lesions.

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Detection of unexpected malignant lesions. Ruling out malignant lesions in case of equivocal lesions identified by clinical examination, mammography, US and/or MRI. [ Time Frame: 6 mounth post scintigraphy ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: October 2009
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Women with equivocal findings on Mammography, US and/or MRI
Women with equivocal findings on Mammography, US and/or MRI
Discrepancy between clinical examination and imaging
Women with discrepancy between clinical examination and breast imaging
Women with dense breast
Women with dense breast
Women in high risk for Breast Cancer
Women in high risk for Breast Cancer. Including patients with genetic high risk and/or strong family history.

Detailed Description:

Recently, a breast-dedicated gamma camera has been used for assessment of breast malignancy in over 1000 women in Mayo Clinic, Rochester, USA. Molecular Breast Imaging (MBI), which utilizes a Cadmium-Zinc-Telluride (CZT) gamma camera for scintimammography, has been shown to have a high sensitivity (91%) for the detection of breast lesions > 5 mm in diameter and 69% for tumors smaller than 5mm.

In Israel , genetic high- risk for breast cancer is highly relevant. We will offer the new imaging technology, to a wide patients population/group from all over Israel , in which the referring physician and/or the breast-imaging physician will look for additional imaging modality. Therefore this stage will include:

  • Women with equivocal findings on Mammography, US and/or MRI
  • Women with discrepancy between CBE(clinical breast examination)and breast imaging
  • Women with dense breast
  • Women in high risk for Breast Cancer

Before the imaging procedure each woman will need to fill detailed questionnaire, specific for the study, that will include information on her medical history, family history, gynecology information, menstrual phase, use of hormones etc.

The images will be correlated with other imaging tests including mammography, US and MRI. We will follow up the women for at least 6 months, including biopsy findings and or other clinical and imaging exams.

This phase will include 500 women.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

A wide COHORT from all over Israel , in which the referring physician and/or the breast-imaging physician will look for additional imaging modality. Women with equivocal findings on Mammography, US and/or MRI. Women with discrepancy between clinical examination and conventional breast imaging. Women with dense breast. Women with genetic and/or family history high risk for Breast Cancer

Criteria

Inclusion Criteria:

  • Age over 25.
  • Equivocal breast lesions.
  • Dense breast tissue.
  • High-risk for breast cancer

Exclusion Criteria:

  • Age under 25.
  • Pregnancy.
  • Patients unable to understand and sign an informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004666

Contacts
Contact: Einat Even-sapir, PhD, MD 972-3-6974444 ext 3536 evensap@tasmc.health.gov.il
Contact: Ayelet Kurzband, BA 972-3-6974444 ext 3536 ayeletk@tasmc.health.gov.il

Locations
Israel
Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Einat Even-Sapir, MD, PhD    972-3-6974444 ext 3536    evensap@tasmc.health.gov.il   
Contact: Ayelet Kurzband, BA    972-3-6974444 ext 3536    ayeletk@tasmc.health.gov.il   
Principal Investigator: Einat Even-Sapir, MD, PhD         
Sub-Investigator: Hedva Lerman, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Einat Even-Sapir, MD, PhD Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
  More Information

Publications:
Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01004666     History of Changes
Other Study ID Numbers: TASMC-09-EE-0192-CTIL
Study First Received: October 29, 2009
Last Updated: January 3, 2013
Health Authority: Israel:
Ministry of Health. Israel: Clinical Trials and Devices.

Keywords provided by Tel-Aviv Sourasky Medical Center:
Breast cancer
Scintimammography
CZT
High-risk

ClinicalTrials.gov processed this record on October 20, 2014