Preoperative Radiation Therapy for Breast Cancer

Overseen By Basak Dogan, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Multi-centric disease, Prior radiation, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

53 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Asal Rahimi, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

This trial is not specified with detailed eligibility criteria. It appears to be for patients with early-stage ER+ breast cancer, focusing on those who are candidates for pre-operative radiation and non-operative sentinel lymph node biopsy.

Inclusion Criteria

My tumor does not affect the skin above it.

My cancer is located in just one area.

Tumor must be visible on CT scan and/or marked with clip(s) in tumor if not visible

Exclusion Criteria

Patients who are pregnant or lactating

My tumor is larger than 3cm.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to Gadolinium or other agents used in study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Radiation

Participants receive a single fraction of 30 Gy pre-operative radiation to evaluate efficacy and pathologic complete response rate

9-10 months

Surgery

Surgery is performed for patients with complete imaging response and negative needle biopsy, or postponed for those with residual disease

10-15 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

Treatment Details

Interventions

• Non-operative Sentinel Lymph Node Biopsy
• PULSAR

Trial Overview The study tests the effectiveness of PULSAR preoperative radiation, explores microbubble CEUS as a non-surgical alternative to sentinel lymph node biopsy (SLNBx), and assesses optical angiography (OA) in evaluating treatment response before surgery.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+