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

• Conditions: Small Breast Lesions; Dense Breast Tissue; Discrepancy With Clinical Examination; Equivocal Mammographic, Sonographic or MRI Lesion

• Registration Number: NCT01004666
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

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.

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-29
• Study First Submitted QC: 2009-10-29
• Study First Posted: 2009-10-30
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-03
• Last Update Posted: 2013-01-04
• Primary Completion: 2014-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of unexpected malignant lesions. Ruling out malignant lesions in case of equivocal lesions identified by clinical examination, mammography, US and/or MRI.	6 mounth post scintigraphy

Trial Locations

Locations (1)

Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel