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RECRUITING Phase 2

Prediction of Neoadjuvant Chemotherapy Response Using Contrast-Enhanced Ultrasound in Patients With Locally Advanced Breast Cancer

NCT04715958 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Perflutren Lipid Microspheres
  • PROCEDURE Contrast-Enhanced Ultrasound
  • PROCEDURE Ultrasound

Study Locations (3)

Minnesota

  • Mayo Clinic — Rochester

Pennsylvania

  • Thomas Jefferson University Hospital — Philadelphia

Texas

  • UT Southwestern/Simmons Cancer Center-Dallas — Dallas

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2020-12-07
Est. Completion 2026-05-31
Phase Phase 2

Sponsor

Kibo Nam

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04715958

The ClinicalTrials.gov registry entry for NCT04715958 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kibo Nam, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions — of which Perflutren Lipid Microspheres is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04715958 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Minnesota, Pennsylvania, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04715958 about?

NCT04715958 is a clinical study titled "Prediction of Neoadjuvant Chemotherapy Response Using Contrast-Enhanced Ultrasound in Patients With Locally Advanced Breast Cancer". 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...

What is the current status of trial NCT04715958?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2020-12-07. Estimated completion is 2026-05-31.

What conditions does trial NCT04715958 study?

This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Locally Advanced Breast Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04715958?

The interventions under investigation include: Perflutren Lipid Microspheres (DRUG), Contrast-Enhanced Ultrasound (PROCEDURE), Ultrasound (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04715958?

This trial is sponsored by Kibo Nam, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04715958 being conducted?

This trial has 3 study locations across Minnesota, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial