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MRI-Guided Radiation Therapy for Breast Cancer (PPI Trial)

N/A

Recruiting

Led By John Ng, M.D.

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is researching if MRI-guided radiation therapy is comparable to current standard treatment for breast radiotherapy in prone position.

Who is the study for?

This trial is for women over 50 with early-stage breast cancer (DCIS or Stage I) who've had a lumpectomy with clear margins. It's not for those who've had radiation on the same breast before, can't have an MRI, are more than 90 days post-surgery without chemo, or more than 60 days post-chemo.

What is being tested?

The study compares two types of radiation therapy after breast-conserving surgery: standard CT-guided treatment and a new MRI-guided method called Precision Prone Irradiation (PPI), to see if they're equally effective at controlling cancer after two years.

What are the potential side effects?

Radiation therapy may cause skin irritation, fatigue, swelling in the treated area, and changes in breast texture. The side effects from MRI-guided PPI are expected to be similar but will be studied for any differences.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Comparing patient reported cosmetic outcomes between patients treated on Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)

Comparing the number of treatment related acute skin toxicities observed in patients who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)

Comparing the number of treatment related late skin toxicities who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)