Skip to main content
OpenTrials
Completed

NCT Number: NCT03176979

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Carcinoma Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contrast Agent

Other

Given IV

Other names: Contrast, Contrast Drugs, contrast material, Contrast Medium

Digital Tomosynthesis Mammography

Procedure

Undergo CESM with DBT

Other names: DBT, Digital Breast Tomosynthesis, Digital Tomosynthesis of the Breast

Dual-Energy Contrast-Enhanced Digital Spectral Mammography

Procedure

Undergo CESM with DBT

Other names: Dual-Energy Contrast-Enhanced Digital Mammography (CEDM), Dual-Energy Contrast-Enhanced Digital Subtraction Mammography

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 6, 2017
Registry last updated
Nov 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.