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Dual Energy Contrast Enhanced Digital Mammography for the Detection and Preoperative Staging of Breast Cancer


N/A
21 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Dual Energy Contrast Enhanced Digital Mammography for the Detection and Preoperative Staging of Breast Cancer


Inclusion Criteria:



- Women with newly diagnosed unilateral breast cancer proven through core biopsy or FNA
who are planned to have (preoperative) MRI within 30 days of DE CEDM to assess extent
of disease/multifocality. (All women will have bilateral digital mammography as per
standard of care.) The preoperative MRI will be based on the surgeon's
recommendation.

- Both breasts are present.

- Women consenting to a bilateral DE CEDM examination.

Exclusion Criteria:

- Women under 21.

- Women who have already had a lumpectomy. (Index lesion has been removed and
therefore, not evaluable for the purpose of this study.)

- Women undergoing neoadjuvant chemotherapy, hormone treatment, or radiation therapy.

- Known pregnancy.

- Women who have a contraindication to the intravenous use of iodinated or
gadolinium-chelated contrast agent.

- Women with breast implants.

- Women with pacemakers.

- Women with aneurysm clips that don't allow for MRI.

- Women too claustrophobic to undergo MRI.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To estimate additional measures of accuracy of DE CEDM and MRI, such as the predictive values and ROC curves where applicable, for detecting multifocal or multicentric disease in the ipsilateral breast.

Outcome Description:

Every attempt will be made to perform all imaging exams All examinations will be completed within 30 days of scheduled surgery

Outcome Time Frame:

within 3 weeks of each other and within 30 days of surgery

Safety Issue:

No

Principal Investigator

Maxine Jochelson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

10-024

NCT ID:

NCT01086514

Start Date:

March 2010

Completion Date:

October 2012

Related Keywords:

  • Breast Cancer
  • Breast
  • mammography
  • MRI
  • Digital Mammography
  • 10-024
  • Breast Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021