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NCT Number: NCT05731791

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10065, United States

About this study

Breast conserving surgery and adjuvant whole breast radiotherapy is a standard treatment option for most patients with early-stage invasive breast cancer. Recent technological advances in radiotherapy have enabled shorter treatment courses, smaller radiation fields, prone positioning, and fewer side effects associated with breast cancer treatment. To further improve target accuracy in breast radiation delivery, an emerging radiotherapy technology takes advantage of on-table MRI imaging and daily adaptive planning during the radiation delivery process.

The objectives of the study are to compare side effects in patients treated under either of these treatment settings and to compare recurrence (if the cancer comes back) rates at a 2-year time point. Patients will have annual follow ups up to 10 years and recurrence rates will be measured at 5-year and at 10-year time points.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiation Therapy to partial breast

Radiation

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).

Primary outcomes

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

    Time frame: 24months

Secondary outcomes

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

    Time frame: 60 months

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

    Time frame: 120 months

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

    Time frame: 60 months

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

    Time frame: 60 months

    Comparing patient reported cosmetic outcomes between patients treated on Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) using the Breast Cancer Treatment Outcome Scale (BCTOS). BCTOS is a widely used questionnaire that is used to compare outcomes of treated and untreated breast by the patient. The questionnaire includes a cosmetic, functional and breast sensitivity questions.

    BCTOS Cosmesis scores range from 1 (excellent) to 4 (poor), and scores of 3 (fair) or more indicate adverse cosmetic outcomes.

  5. 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)

    Time frame: 6 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) using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 5.0 (NCI CTCAEv5.0).

  6. 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)

    Time frame: 12 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) using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 5.0 (NCI CTCAEv5.0).

  7. 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)

    Time frame: 24 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) using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 5.0 (NCI CTCAEv5.0).

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

    Time frame: 6 months

    Comparing the number of treatment related late skin toxicities who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 5.0 (NCI CTCAEv5.0).

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

    Time frame: 12 months

    Comparing the number of treatment related late skin toxicities who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 5.0 (NCI CTCAEv5.0).

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

    Time frame: 24 months

    Comparing the number of treatment related late skin toxicities who received either Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 5.0 (NCI CTCAEv5.0).

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

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

Acronym: PPI

Important dates

Study start
2023
Primary completion
2026
Study completion
2034
First posted
Feb 16, 2023
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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