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

NCT ID: NCT04625517

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-22
• Study Completion Date: 2022-06-15

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.

Detailed Description

The use of neoadjuvant systemic therapy in the treatment of breast cancer patients is increasing beyond the scope of locally advanced disease. Imaging provides important information in assessing response to therapy as a complement to conventional tumor measurements via physical examination. Tumor response to neoadjuvant therapy can also provide prognostic information. The attainment of pCR after completion of neoadjuvant therapy and surgical resection is associated with improved disease-free survival. This correlation is especially strong for Triple-receptor negative and human epidermal growth factor receptor 2 (HER-2) positive breast cancer. Studies of neoadjuvant therapy have used a variety of methods for assessing tumor response. Currently, there are no established clinical practice guidelines for how best to assess tumor response to neoadjuvant therapy. Typically, patients undergo conventional breast imaging such as mammography and ultrasonography (US) and physical examination, and dynamic contrast-enhanced breast magnetic resonance imaging (DCR-MRI) in selected cases.

Contrast Enhanced Digital Mammography (CEDM) is a novel imaging technique, which allows digital mammography to be used with contrast enhancement to depict cancers that would otherwise be occult on standard unenhanced mammography. CEDM is performed with and without intravenous iodine contrast, using the dual energy subtraction technique. Compared with mammography and US, CEDM improves the sensitivity for breast cancer detection without decreasing specificity. CEDM digital detector has higher spatial resolution than MRI, revealing details that are approximately 10 times better. In contrast to the rapid washout in MRI, enhancement on CEDM in fact persists for at least 10 min after contrast agent infusion. Today CEDM is available commercially for clinical use. It is estimated that over 200,000 CEDM examinations have been performed to date in both research and clinical settings. CEDM costs significantly less compared to MRI. Furthermore, longer time delays between contrast injection and CEDM exposure could result in stronger enhancement and hence better visibility compared to MRI, especially given the much higher spatial resolution of digital mammography. It is unknown whether CEDM can improve the sensitivity of mammography in the early assessment of neoadjuvant therapy response. We hypothesize that CEDM is superior to mammography and ultrasound in assessing early response, and pre-surgical residual cancer after neoadjuvant therapy, and when performed, non-inferior to MRI in assessing the residual disease using the metrics of pCR and residual cancer burden (RCB).

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Breast cancer patients

Patients with ipsilateral intact biopsy-proven breast cancer

Group Type: EXPERIMENTAL

Digital Mammography

Intervention Type: PROCEDURE

Digital Mammography enhanced with an iodinated contrast agent

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

Intervention Type: DRUG

Injection of low osmolar contrast material during the digital mammography exam

Interventions

Digital Mammography

Digital Mammography enhanced with an iodinated contrast agent

Intervention Type: PROCEDURE

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

Injection of low osmolar contrast material during the digital mammography exam

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Basak Dogan, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Basak Dogan, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STU-2019-0529

Identifier Type: -

Identifier Source: org_study_id