MedTrace Logo

Performance of Contrast-Enhanced Spectral Mammography to Assess Neoadjuvant Chemotherapy Response (CEDM)

NCT04625517 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-10-12

Study results available
· View outcomes & findings →

Summary

This study is designed to investigate the diagnostic accuracy of Contrast Enhanced Spectral Mammography (CEDM) in predicting early neoadjuvant therapy response and pathologic complete response (pCR) compared to mammography.

Patients diagnosed with invasive breast cancer with available mammography and ultrasound imaging are eligible for the study.

Eligible patients will be imaged at baseline (before initiation of neoadjuvant chemotherapy or endocrine therapy), early (2-4 cycles of neoadjuvant therapy) and late (after completion of neoadjuvant chemotherapy or endocrine therapy) timepoints with mammography. CEDM will be done within 2 weeks of the specified timepoint. Additionally, a survey of subject experience with CEDM and other pre-operative imaging will be collected after CEDM is performed.

Conditions

Interventions

PROCEDURE

Digital Mammography

Digital Mammography enhanced with an iodinated contrast agent

DRUG

Low Osmolar Contrast Material, 300-399 Mg/Ml Iodine Concentration, Per Ml

Injection of low osmolar contrast material during the digital mammography exam

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Basak Dogan, MD · UT Southwestern Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-22
Primary Completion
2022-06-15
Completion
2022-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04625517 on ClinicalTrials.gov