CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 53 target
Drug / intervention
microbubble CEUS Contrast Enhanced Ultrasound (CEUS) +1 moredrug
Likely dose
Not stated in record
Key inclusion· 11
  • Invasive epithelial breast cancer (ductal, medullary, lobular, papillary, mucinous, or tubular) ≤3cm (T1-T2cN0), no prior surgery or neoadjuvant endocrine/chemotherapy
  • Age ≥18 years and female
  • Tumor dimension ≤3cm on ultrasound
  • Unifocal tumor
Key exclusion· 8
  • Multi-centric disease
  • Prior radiation to involved breast
  • Tumor size >3cm
  • Pregnant or lactating

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06444269
NCT06444269Phase 2RecruitingOn TrackUpdated 7mo ago

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

University of Texas Southwestern Medical Center·interventional·Posted Jun 5, 2024·Updated Nov 5, 2025

In Brief

A Phase 2 clinical trial evaluating Radiomics on MRI and microbubble CEUS Contrast Enhanced Ultrasound (CEUS) for Breast Cancer. Currently recruiting, targeting 53 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2Recruiting
2025202620272028
First PostedJun 5, 2024
Enrollment StartOct 11, 2024
Primary CompletionJul 1, 2027
Study CompletionJul 1, 2028
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 2.1 years agoPrimary completion in 12 months

Interventions

Radiomics on MRIradiation

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.

microbubble CEUS Contrast Enhanced Ultrasound (CEUS)drug

Microbubble Contrast non-FDA approved for route of administration