SHAPE Neoadjuvant Chemotherapy Response

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Kibo Nam
Study ID
NCT04715958
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Contrast-Enhanced Ultrasound — PROCEDURE
    Undergo CEUS
  • Perflutren Lipid Microspheres — DRUG
    Given IV
  • Ultrasound — PROCEDURE
    Undergo unenhanced baseline ultrasound

Study Details

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.

Key Dates

Start date
Dec 7, 2020
Status verified
Feb 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Diagnostic (CEUS, Definity)
    Patients undergo CEUS and receive perflutren lipid microspheres IV over 10-15 minutes before NAC, after 10% of NAC, and after 30% of NAC. Patients also undergo unenhanced baseline ultrasound imaging before NAC, after 10% of NAC, after 30% of NAC, and after 100% of NAC

Primary Outcome Measure

Calculation of tumor volume changes with neoadjuvant chemotherapy (NAC) [ Time Frame: Up to study completion (48 months) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Jaydev Dave, PhD
[email protected]
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Kibo Nam, PhD
[email protected]
215-955-6261
Kibo Nam, PhD (PRINCIPAL_INVESTIGATOR)
UT Southwestern/Simmons Cancer Center-DallasDallasTexas75390
Basak Dogan
[email protected]
214-645-9729

Find similar trials in Rochester, MN

By research site
Mayo Clinic· Rochester, MNThomas Jefferson University Hospital· Philadelphia, PAUT Southwestern/Simmons Cancer Center-Dallas· Dallas, TX

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