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

NCT03176979 | Completed DMC

• 3 other identifiers: 1B-16-3NCI-2017-00778P30CA014089
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Index lesion size using the largest diameter

  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.

  Baseline

Study Arms (1)

Diagnostic (CESM with DBT)

EXPERIMENTAL

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; Procedure: Digital Tomosynthesis Mammography; Procedure: Dual-Energy Contrast-Enhanced Digital Spectral Mammography

Interventions

Contrast Agent OTHER

Given IV

Also known as: Contrast, Contrast Drugs, contrast material, Contrast Medium

Diagnostic (CESM with DBT)

Digital Tomosynthesis Mammography PROCEDURE

Undergo CESM with DBT

Also known as: DBT, Digital Breast Tomosynthesis, Digital Tomosynthesis of the Breast

Diagnostic (CESM with DBT)

Dual-Energy Contrast-Enhanced Digital Spectral Mammography PROCEDURE

Undergo CESM with DBT

Also known as: Dual-Energy Contrast-Enhanced Digital Mammography (CEDM), Dual-Energy Contrast-Enhanced Digital Subtraction Mammography

Diagnostic (CESM with DBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed breast cancer patients

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Contrast Media

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Mary Yamashita, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 6, 2017
• Study Start: April 21, 2017
• Primary Completion: July 8, 2021
• Study Completion: July 8, 2021
• Last Updated: November 18, 2021

Record last verified: 2021-11

Locations

US (1)