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

25 Years
Open (Enrolling)
Small Breast Lesions, Dense Breast Tissue, Discrepancy With Clinical Examination, Equivocal Mammographic, Sonographic or MRI Lesion

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Trial Information

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

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.

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Detection of unexpected malignant lesions. Ruling out malignant lesions in case of equivocal lesions identified by clinical examination, mammography, US and/or MRI.

Outcome Time Frame:

6 mounth post scintigraphy

Safety Issue:


Principal Investigator

Einat Even-Sapir, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tel Aviv Sourasky Medical Center, Tel Aviv, Israel



Study ID:




Start Date:

October 2009

Completion Date:

October 2015

Related Keywords:

  • Small Breast Lesions
  • Dense Breast Tissue
  • Discrepancy With Clinical Examination
  • Equivocal Mammographic, Sonographic or MRI Lesion
  • Breast cancer
  • Scintimammography
  • CZT
  • High-risk