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Contrast Enhanced Spectral Mammography With Digital Breast Tomosynthesis For Patients With Newly Diagnosed Breast Cancer

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ClinicalTrials.gov Identifier: NCT03176979
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Brief Summary:
This pilot clinical trial studies how well contrast enhanced spectral mammography works with digital breast tomosynthesis in imaging patients with newly diagnosed breast cancer. Contrast enhanced spectral mammography uses a special dye that is injected into the veins before mammogram images are taken. Digital breast tomosynthesis uses multiple x-ray pictures to produce a 3-dimensional rendering of the entire breast. Contrast enhanced spectral mammography with digital breast tomosynthesis may highlight areas of concern within the breast in more detail than a standard mammogram and improve the accuracy of tumor size.

Condition or disease Intervention/treatment Phase
Breast Carcinoma Other: Contrast Agent Procedure: Digital Tomosynthesis Mammography Procedure: Dual-Energy Contrast-Enhanced Digital Spectral Mammography Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To compare the index lesion size (the largest diameter) from each of the four readings (standard of care 2 dimensional [D], magnetic resonance imaging [MRI], contrast enhanced spectral mammography [CESM], 3D) to gold standard index lesion size from surgical pathology (the largest diameter).

II. To document the additional ipsilateral and contralateral breast cancer lesions detected by the MRI, CESM, and 3D readings listed above.

OUTLINE:

Patients undergo a clinical breast examination and a diagnostic mammogram with or without targeted breast ultrasound to the index cancer as part of their standard of care preoperative work-up. As part of the research study, patients receive contrast agent intravenously (IV) and then undergo a CESM with digital breast tomosynthesis (DBT) over 30 minutes. Patients also receive a contrast agent, gadolinium, IV and undergo bilateral breast contrast enhanced (CE)-MRI over 10 minutes.

After completion of study, patients are followed up within 24-96 hours.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Emerging Tools in the Detection of Breast Cancer: Comparison of Contrast Enhanced Spectral Mammography With Digital Breast Tomosynthesis to Conventional Imaging Techniques Including Contrast Enhanced Magnetic Resonance Imaging and 2D Mammography With or Without Targeted Ultrasound
Actual Study Start Date : April 21, 2017
Estimated Primary Completion Date : April 21, 2020
Estimated Study Completion Date : April 21, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic (CESM with DBT)
Patients undergo a clinical breast examination and a diagnostic mammogram with or without targeted breast ultrasound to the index cancer as part of their standard of care preoperative work-up. As part of the research study, patients receive contrast agent IV and then undergo a CESM with DBT over 30 minutes. Patients also receive a contrast agent, gadolinium, IV and undergo bilateral breast CE-MRI over 10 minutes.
Other: Contrast Agent
Given IV
Other Names:
  • Contrast
  • Contrast Drugs
  • contrast material
  • Contrast Medium

Procedure: Digital Tomosynthesis Mammography
Undergo CESM with DBT
Other Names:
  • DBT
  • Digital Breast Tomosynthesis
  • Digital Tomosynthesis of the Breast

Procedure: Dual-Energy Contrast-Enhanced Digital Spectral Mammography
Undergo CESM with DBT
Other Names:
  • Dual-Energy Contrast-Enhanced Digital Mammography (CEDM)
  • Dual-Energy Contrast-Enhanced Digital Subtraction Mammography




Primary Outcome Measures :
  1. Index lesion size using the largest diameter [ Time Frame: Baseline ]
    Intra-class correlation will be used to assess the agreement of index lesion size from each imaging reading to the gold standard (histopathology at surgery). Bland-Altman plot will be used to illustrate the pattern of difference between each reading and the gold standard.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed breast cancer patients

Exclusion Criteria:

  • Women with history of surgical, medical, or radiation therapy for breast cancer
  • Women with renal failure or insufficiency
  • Women with iodine contrast allergy
  • Women with gadolinium contrast allergy
  • Women who are pregnant, possibly pregnant, or lactating
  • Women undergoing neoadjuvant chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176979


Contacts
Contact: Zeno Ashai, MPH 323-865-0463 zeno.ashai@med.usc.edu

Locations
United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Mary Yamashita    323-865-3203    mary.yamashita@usc.edu   
Principal Investigator: Mary Yamashita         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
Principal Investigator: Mary Yamashita, MD University of Southern California

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03176979     History of Changes
Other Study ID Numbers: 1B-16-3
NCI-2017-00778 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
1B-16-3 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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