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ACTIVE NOT RECRUITING
NCT04040569
PHASE1

A Phase I Dose Escalation Study of Single Fraction Pre-operative Partial Breast (S-PBI) for Early Stage Breast Cancer

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

Summary

The purpose of this phase I trial is to evaluate dose-limiting toxicity while dose escalating single-fraction preoperative S-PBI to a presumed radioablative dose over 3 cohorts, starting with 30Gy in 1 fraction and advancing to 34Gy and 38Gy in 1 fraction.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2019-12-25

Completion Date

2027-07

Last Updated

2025-09-17

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.

Locations (1)

University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, United States