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

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Recruiting
    • Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center
    • Principal Investigator: Einat Even-Sapir, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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 in high risk for Breast Cancer; Women in high risk for Breast Cancer. Including patients with genetic high risk and/or strong family history.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Publications and helpful links

General Publications

• Hruska CB, Phillips SW, Whaley DH, Rhodes DJ, O'Connor MK. Molecular breast imaging: use of a dual-head dedicated gamma camera to detect small breast tumors. AJR Am J Roentgenol. 2008 Dec;191(6):1805-15. doi: 10.2214/AJR.07.3693.
• Hruska CB, Boughey JC, Phillips SW, Rhodes DJ, Wahner-Roedler DL, Whaley DH, Degnim AC, O'Connor MK. Scientific Impact Recognition Award: Molecular breast imaging: a review of the Mayo Clinic experience. Am J Surg. 2008 Oct;196(4):470-6. doi: 10.1016/j.amjsurg.2008.06.005. Epub 2008 Aug 23.
• Hruska CB, O'Connor MK. Quantification of lesion size, depth, and uptake using a dual-head molecular breast imaging system. Med Phys. 2008 Apr;35(4):1365-76. doi: 10.1118/1.2885371.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Anticipated): October 1, 2014
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: October 29, 2009
• First Submitted That Met QC Criteria: October 29, 2009
• First Posted (Estimate): October 30, 2009

Study Record Updates

• Last Update Posted (Estimate): January 4, 2013
• Last Update Submitted That Met QC Criteria: January 3, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Breast cancer; High-risk; CZT; Scintimammography
• Other Study ID Numbers: TASMC-09-EE-0192-CTIL