Preoperative Radiation Therapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAsal Rahimi, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Texas Southwestern Medical Center

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

No Placebo Group

Prior Safety Data

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.

I am a woman aged 18 or older.

See 9 more

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

See 5 more

Trial 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

Trial OverviewThe 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.