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

Dense Breast Tissue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01004666
• Other study ID #: TASMC-09-EE-0192-CTIL
• Status: Recruiting
• Phase: N/A
• First received: October 29, 2009
• Last updated: January 3, 2013
• Start date: October 2009
• Est. completion date: October 2015

Study information

• Verified date: January 2013
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Einat Even-sapir, PhD, MD
• Phone: 972-3-6974444
• Email: evensap[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel:Ministry of Health. Israel: Clinical Trials and Devices.
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Israel	Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View Citation

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. — View Citation

Hruskaa 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No