Digital Mammography for the Detection and Preoperative Staging of Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01086514
First received: March 11, 2010
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

Breast tumors are normally seen with mammography or ultrasound without the use of a dye but the size and extent of the tumor may be hard to see. Currently, after initial mammography, many patients undergo bilateral breast MR to further stage the local tumor. It is able to not only detect anatomic abnormalities but can also evaluate changes such as the development of new blood vessels, which occurs with the development of cancers. MRI is extremely sensitive and detects unsuspected disease in up to 25% of patients, which affects their treatment. It also detects unsuspected cancer in the other breast in some patients.

However, MRI is expensive, not always available, and some patients are unable to undergo MRI due to the presence of pacemakers, clips, or claustrophobia. Dual Energy Contrast Enhanced Digital Mammography (DE CEDM) is an investigational procedure that uses a non-standard contrast in a regular digital mammography exam that has been changed to give the needed dual energy and image. DE CEDM is not FDA approved. It is our hope that DE CEDM will also be able to detect unknown tumors because it will also detect new blood vessels. It is less expensive than MRI, could be more available to patients, and can be done on patients with pacemakers and clips. Claustrophobia will not be a problem. We plan to see if (DE CEDM) will help us better see the breast tumor and size of the breast tumor. We will also want to see if DE CEDM can detect additional unsuspected disease in the breast with the known tumor and in the other breast without a known tumor.


Condition Intervention
Breast Cancer
Procedure: Dual Energy Contrast Enhanced Digital Mammography (DE CEDM)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Dual Energy Contrast Enhanced Digital Mammography for the Detection and Preoperative Staging of Breast Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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. [ Time Frame: within 3 weeks of each other and within 30 days of surgery ] [ Designated as safety issue: No ]
    Every attempt will be made to perform all imaging exams All examinations will be completed within 30 days of scheduled surgery


Secondary Outcome Measures:
  • To compare the sensitivity and specificity of DE CEDM with that of breast MRI in the detection of disease in the contralateral breast. [ Time Frame: within 3 weeks of each other and within 30 days of surgery ] [ Designated as safety issue: No ]
    Every attempt will be made to perform all imaging exams All examinations will be completed within 30 days of scheduled surgery

  • To estimate the interobserver variability of DE CEDM. [ Time Frame: within 3 weeks of each other and within 30 days of surgery ] [ Designated as safety issue: No ]
    Every attempt will be made to perform all imaging exams All examinations will be completed within 30 days of scheduled surgery


Estimated Enrollment: 220
Study Start Date: March 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dual Energy Contrast Enhanced Digital Mammography (DE CEDM)
In this study we will perform Dual Energy Contrast Enhanced Digital Mammography (DE CEDM) on patients with newly diagnosed breast cancer using a dedicated research system, derived from a standard digital mammography unit and review workstation (Senographe DS and SenoAdvantage) modified to deliver the required dual energy paired exposures and visualization of combined images.
Procedure: Dual Energy Contrast Enhanced Digital Mammography (DE CEDM)
Each patient will have: Bilateral digital mammography, Bilateral Breast MRI, Bilateral Contrast Enhanced Digital Mammography. The latter examination is the only change in patient management. An additional contrast injection is involved. Results of the DE CEDM will be compared with routine digital mammography and breast MRI. The reference standard is pathology. If surgery is to be done; every attempt will be made to perform all imaging exams within 30 days.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086514

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
GE Healthcare
Investigators
Principal Investigator: Maxine Jochelson, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01086514     History of Changes
Other Study ID Numbers: 10-024
Study First Received: March 11, 2010
Last Updated: October 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Breast
mammography
MRI
Digital Mammography
10-024

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014