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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: Recruiting Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Locally Advanced Breast Carcinoma, sponsored by Kibo Nam.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
3-dimensional (3D) tumor measurements over the three ultrasound exams will be recorded for each subject to calculate tumor volume changes with NAC. The tumor volume change during the therapy will be compared to imaging (magnetic resonance imaging or ultrasound) and pathologic response as well as to the corresponding 3D subharmonic aided pressure estimation (SHAPE) results.
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 |
What NCT04715958 shows while recruiting
NCT04715958 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 302-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (34% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04715958's enrollment target sits among peer trials
200 24th of 84 higher than 60 of 84 other Anatomic Stage III Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage III Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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