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NCT04625517 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.

Terminated
Registry status
Phase 4
Development phase
6
Enrollment target

NCT04625517 is a Phase 4 study that was terminated before completion, run by University of Texas Southwestern Medical Center. The registered enrollment target is 6 participants.

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The verdict

NCT04625517, a Phase 4 study, was terminated before completion, sponsored by University of Texas Southwestern Medical Center.

TERMINATED
Registry status
Phase 4
Development phase
6 participants
Enrollment target

Study 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.

Interventions

  • PROCEDURE Digital Mammography
  • DRUG Low Osmolar Contrast Material, 300-399 Mg/Ml Iodine Concentration, Per Ml

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2020-01-22
Est. Completion 2022-06-15
Phase Phase 4

What the Registry Record Tells You About NCT04625517

The ClinicalTrials.gov registry entry for NCT04625517 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Digital Mammography is the first listed.

NCT04625517 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04625517 about?

NCT04625517 is a clinical study titled "Performance of Contrast-Enhanced Spectral Mammography to Assess Neoadjuvant Chemotherapy Response (CEDM)". 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 a...

What is the current status of trial NCT04625517?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 6 participants. The study started on 2020-01-22. Estimated completion is 2022-06-15.

What interventions are being tested in trial NCT04625517?

The interventions under investigation include: Digital Mammography (PROCEDURE), Low Osmolar Contrast Material, 300-399 Mg/Ml Iodine Concentration, Per Ml (DRUG).

Who is sponsoring clinical trial NCT04625517?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.