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Active Not Recruiting
NCT05731791
Trial to Compare MRI-guided Precision Prone Irradiation (PPI) Versus CT-guided Breast Irradiation
Conditions: Breast Cancer
Sex: Female
Ages: 50 Years – 90 Years
Healthy volunteers: No
Phase: NA
Enrollment: 17
Sponsor: Weill Medical College of Cornell University
Location: Weill Cornell Medicine New York New York
Summary
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.
Eligibility Criteria
Patients ≥ 50 yrs with histologically confirmed unilateral DCIS or Stage I invasive breast cancer; received breast conserving surgery (pN0 or pNx) with tumor pathology ≤ 2 cm and excision margin ≥ 1 mm
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT05731791). StuddyBuddy aggregates publicly available trial information.