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

October 29, 2009
January 3, 2013
October 2009
October 2014   (final data collection date for primary 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. [ Time Frame: 6 mounth post scintigraphy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01004666 on ClinicalTrials.gov Archive Site
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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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

  • Small Breast Lesions
  • Dense Breast Tissue
  • Discrepancy With Clinical Examination
  • Equivocal Mammographic, Sonographic or MRI Lesion
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
October 2015
October 2014   (final data collection date for primary outcome measure)

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
Female
25 Years and older
Yes
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
Israel
 
NCT01004666
TASMC-09-EE-0192-CTIL
Yes
Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
Not Provided
Principal Investigator: Einat Even-Sapir, MD, PhD Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
Tel-Aviv Sourasky Medical Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP