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

NCT04625517 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: STU-2019-0529
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

mammography; contrast enhanced spectral mammography

Outcome Measures

Primary Outcomes (6)

• Sensitivity of Predicting pCR (Pathologic Complete Response) for CEDM

  Sensitivities in predicting pCR will be calculated for CEDM and measured as AUC

  4 to 6 months from initiation of neoadjuvant therapy until final surgery

• Sensitivity of Predicting pCR (Pathologic Complete Response) for Mammography

  Sensitivities in predicting pCR will be calculated for mammography measured as AUC

  4 to 6 months from initiation of neoadjuvant therapy until final surgery

• Specificity of Predicting pCR (Pathologic Complete Response) for CEDM

  Specificity of predicting pCR will be calculated for CEDM and measured as AUC

  4 to 6 months from initiation of neoadjuvant therapy until final surgery

• Specificity of Predicting pCR (Pathologic Complete Response) for Mammography

  Specificity of predicting pCR will be calculated for mammography and measured as AUC

  4 to 6 months from initiation of neoadjuvant therapy until final surgery

• Diagnostic Accuracy of Contrast-enhanced Mammography in Assessing pCR or Non Response

  ROC analysis will be used to assess the diagnostic performance of CEDM. The Area under the receiver operating characteristic (ROC) curve (AUC) will be compared. A leave-one-out cross validation algorithm will be used to reduce bias from overfitting.

  4 to 6 months from initiation of neoadjuvant therapy until final surgery

• Correlation of Residual Tumor Size With Pathologic Size

  Spearman's rank correlation will be used to measure the association between final pathologic and imaging tumor size

  4 to 6 months from initiation of neoadjuvant therapy until final surgery

Study Arms (1)

Breast cancer patients

EXPERIMENTAL

Patients with ipsilateral intact biopsy-proven breast cancer

Procedure: Digital Mammography; Drug: Low Osmolar Contrast Material, 300-399 Mg/Ml Iodine Concentration, Per Ml

Interventions

Digital Mammography PROCEDURE

Digital Mammography enhanced with an iodinated contrast agent

Breast cancer patients

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

Injection of low osmolar contrast material during the digital mammography exam

Breast cancer patients

Eligibility Criteria

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

You may qualify if:

• Ipsilateral intact biopsy-proven breast cancer clinical stage T1-T4 (by imaging)
• Available mammography and ultrasound imaging of the existing index cancer, with orthogonal measurements
• Prior history of ipsilateral or contralateral breast cancer, presenting with a new primary or recurrent disease
• Patients who were determined to be candidates for either neoadjuvant chemotherapy or neoadjuvant endocrine therapy by the treating physician
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

You may not qualify if:

• History of ipsilateral mastectomy
• Women who already started neoadjuvant chemotherapy or endocrine therapy
• Woman who may be pregnant or nursing an infant
• Prior history of anaphylactic or anaphylactoid reaction to any contrast.
• Prior allergy to iodine or iodinated contrast.
• Impaired renal function measured by estimated glomerular filtration rate (eGFR) \< 60 milliliters per minute.
• Patients with known distant metastasis.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Kelli Key, Ph.D.
• Organization: UT Southwestern Medical Center

Kelli.Key@UTSouthwestern.edu

214-648-8152

Study Officials

• Basak Dogan, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 12, 2020
• Study Start: January 22, 2020
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: October 12, 2023
• Results First Posted: October 12, 2023

Record last verified: 2023-10

Locations

US (1)