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NCT04715958 · ClinicalTrials.gov registry record · Phase 2
Prediction of Neoadjuvant Chemotherapy Response Using Contrast-Enhanced Ultrasound in Patients With Locally Advanced Breast Cancer
A Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Locally Advanced Breast Carcinoma, sponsored by Kibo Nam.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 3
- Study locations
NCT04715958 is a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Locally Advanced Breast Carcinoma that is actively recruiting participants, run by Kibo Nam. The registered enrollment target is 200 participants, below the 302-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (34% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT04715958, a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Locally Advanced Breast Carcinoma, is actively recruiting participants, sponsored by Kibo Nam.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 3
- Study locations
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 Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2020-12-07 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 302-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (34% lower). The listed sponsor is Kibo Nam, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT04715958 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Minnesota, Pennsylvania, Texas.
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.
What interventions are being tested in trial NCT04715958?
The interventions under investigation include: Perflutren Lipid Microspheres (DRUG), Contrast-Enhanced Ultrasound (PROCEDURE), Ultrasound (PROCEDURE).
Who is sponsoring clinical trial NCT04715958?
This trial is sponsored by Kibo Nam, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
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