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SHAPE Neoadjuvant Chemotherapy Response

NCT04715958 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-04-06

No results posted yet for this study

Summary

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.

Conditions

  • Anatomic Stage III Breast Cancer AJCC v8
  • Locally Advanced Breast Carcinoma

Interventions

PROCEDURE

Contrast-Enhanced Ultrasound

Undergo CEUS

DRUG

Perflutren Lipid Microspheres

Given IV

PROCEDURE

Ultrasound

Undergo unenhanced baseline ultrasound

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Kibo Nam

    lead OTHER

Principal Investigators

  • Kibo Nam, MD · Thomas Jefferson University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-07
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04715958 on ClinicalTrials.gov