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RECRUITING
NCT06444269
PHASE2

Precision Medicine in Action: Phase II Trial of Response Adaptive Ablative Pre-operative SPBI (RAPS) and Non-operative Sentinel Lymph Node Biopsy in Patients With Early-stage ER+ Breast Cancer: RAPS Trial

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

Summary

1\. Efficacy of PULSAR preoperative radiation 2. Evaluate potential of microbubble CEUS as an alternative to operative SLNBx 3. Evaluate potential of OA to evaluate treatment response of pre-operative radiation on the tumor

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

53

Start Date

2024-10-11

Completion Date

2028-07-01

Last Updated

2025-11-05

Healthy Volunteers

No

Conditions

Interventions

RADIATION

Radiomics on MRI

Through extracting and analyzing a large number of features from medical imaging, radiomics has shown promising results in treatment outcome prediction for many diseases including breast cancer (45-50). UTSW physics group has developed several new radiomic approaches and radiomic features, such as a multi-objective radiomics model(51) and a new radiomic "Shell" feature(52). As an exploratory end point for this trial, the investigators will explore the application radiomics using pre-treatment MRI, treatment parameters and clinical characteristics as input to predict pathological response of radiation therapy (XRT) based on pathology report of surgical tissues and local recurrence.

DRUG

microbubble CEUS Contrast Enhanced Ultrasound (CEUS)

Microbubble Contrast non-FDA approved for route of administration

Locations (1)

UT Southwestern Medical Center-Dallas

Dallas, Texas, United States