NCT05731791

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
99mo left

Started Apr 2023

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Apr 2023Jul 2034

First Submitted

Initial submission to the registry

February 7, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 3, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2034

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

3.2 years

First QC Date

February 7, 2023

Last Update Submit

January 22, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Comparing local recurrence rates between patients receiving Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)

    24months

Secondary Outcomes (10)

  • Comparing local recurrence rates between patients receiving Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)

    60 months

  • Comparing number of participants with local recurrence between patients treated on Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)

    120 months

  • Comparing clinical and planning target volumes (CTV and PTV volumes) for CT-based planning vs. MRI-based planning

    60 months

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

    60 months

  • 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)

    6 months

  • +5 more secondary outcomes

Study Arms (2)

ARM 1 - CT-based breast radiation treatment

ACTIVE COMPARATOR

Patients randomized to ARM 1 will receive 3000 cGy in 5 fractions partial breast radiotherapy with CT-based breast radiation treatment.

Radiation: Radiation Therapy to partial breast

ARM 2 - MRI-based breast radiation treatment

ACTIVE COMPARATOR

Patients randomized to ARM 2 will receive 3000 cGy in 5 fractions partial breast radiotherapy with MRI-based breast radiation treatment.

Radiation: Radiation Therapy to partial breast

Interventions

Radiation Therapy to partial breastRADIATION

Patients randomized to ARM 1 will receive 3000 cGy in 5 fractions partial breast radiotherapy with CT-based breast radiation treatment (Arm 1) and patients randomized to ARM 2 will receive 3000 cGy in 5 fractions partial breast radiotherapy with MRI-based breast radiation treatment (Arm 2).

ARM 1 - CT-based breast radiation treatmentARM 2 - MRI-based breast radiation treatment

Eligibility Criteria

Age50 Years - 90 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • John Ng, M.D.

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Phase 3 two-armed randomized clinical trial for localized favorable breast cancer patients, randomizing to CT-based radiation treatment vs. MRI-based radiation treatment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2023

First Posted

February 16, 2023

Study Start

April 3, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2034

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)