NCT01004666

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2009

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 4, 2013

Status Verified

January 1, 2013

Enrollment Period

5 years

First QC Date

October 29, 2009

Last Update Submit

January 3, 2013

Conditions

Small Breast LesionsDense Breast TissueDiscrepancy With Clinical ExaminationEquivocal Mammographic, Sonographic or MRI Lesion

Keywords

Breast cancerScintimammographyCZTHigh-risk

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

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.

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Age over 25.
  • Equivocal breast lesions.
  • Dense breast tissue.
  • High-risk for breast cancer

You may not qualify if:

  • Age under 25.
  • Pregnancy.
  • Patients unable to understand and sign an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Related Publications (3)

  • 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.

    PMID: 19020253BACKGROUND

  • 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.

    PMID: 18723155BACKGROUND

  • 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.

    PMID: 18491531BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Einat Even-Sapir, MD, PhD

    Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Einat Even-sapir, PhD, MD

CONTACT

972-3-6974444evensap@tasmc.health.gov.il

Ayelet Kurzband, BA

CONTACT

972-3-6974444ayeletk@tasmc.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2009

First Posted

October 30, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2014

Study Completion

October 1, 2015

Last Updated

January 4, 2013

Record last verified: 2013-01

Locations

IL(1)