Trial to Compare MRI-guided Precision Prone Irradiation (PPI) Versus CT-guided Breast Irradiation

Running, not enrolling · Not applicable

Conditions studied: Breast Cancer

In brief

The Investigators are investigating the potential role of MRI-guided Radiation Therapy for patients receiving breast radiotherapy in the prone position with a MRI-Linac radiotherapy system, the Precision Prone Irradiation (PPI) technique. Hypothesis: The investigators would like to hypothesize that breast radiation therapy using MRI-guided system including the MRI-Linac (Arm 2) is comparable to the current standard of treatment using conventional CT-based system (Arm 1), in terms of local control of the disease at 2 year time point.

Key facts

Study ID

NCT05731791

Run by

Weill Medical College of Cornell University

People needed

17

Starts

2023-04-03

Expected to finish

2034-07-01

Last updated by the study team

2026-01-23

Who can join

Age: 50 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women status post segmental mastectomy
• If unilateral, pT1 breast cancer excised with negative margins AND/OR pTis excised with negative margins.
• If bilateral, pT1 breast cancer excised with negative margins AND/OR pTis excised with negative margins.
• Clinically N0 or pN0 or sentinel node negative
• Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins).

You may not qualify if…

• Previous radiation therapy to the ipsilateral breast.
• > 90 days from last surgery, unless s/p adjuvant chemotherapy
• > 60 days from last chemotherapy
• Patients unable to tolerate MRI or are otherwise unsuitable for MRI-based RT treatment
• Metastatic disease

Where it is running

• Weill Cornell Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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