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Active, not recruiting Phase 2Phase 3 Interventional

SHAPE Neoadjuvant Chemotherapy Response

ClinicalTrials.gov ID: NCT04715958

Public ClinicalTrials.gov record NCT04715958. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 9:14 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Monitoring Neoadjuvant Chemotherapy of Breast Cancer Using 3D Subharmonic Aided Pressure Estimation

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This phase II/III trial studies if contrast-enhanced ultrasounds using a contrast dye, perflutren lipid microspheres (Definity), can predict the response to chemotherapy by estimating the pressure in the cancer in patients with breast cancer that has spread to nearby tissues and lymph nodes (locally advanced). The efficacy of cancer therapy is affected by the pressure in the cancer. Definity is a contrast dye used to create better images during ultrasounds. The purpose of this trial is to determine if a special kind of ultrasound, called contrast-enhanced ultrasound, an experimental imaging test, can detect pressures in cancer to determine the response to neoadjuvant chemotherapy in patients with breast cancer.

Study identification

NCT ID
NCT04715958
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Kibo Nam
Other
Enrollment
122 participants

Conditions and interventions

Eligibility (public fields only)

Age range
21 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 6, 2020
Primary completion
Oct 30, 2026
Completion
Oct 30, 2026
Last update posted
Jun 17, 2026

2020 – 2026

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
Mayo Clinic Rochester Minnesota 55905
Thomas Jefferson University Hospital Philadelphia Pennsylvania 19107
UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas 75390

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04715958, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 17, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04715958 live on ClinicalTrials.gov.

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