Breast CancerPPINCT05731791
Trial to Compare MRI-guided Precision Prone Irradiation (PPI) Versus CT-guided Breast Irradiation
A study testing Radiation Therapy to partial breast in people with Breast Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radiation Therapy to partial breast
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2023to 1 Jul 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized 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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- Radiation Therapy to partial breast
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: Radiation Therapy to partial breast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing local recurrence rates between patients receiving Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)
Measured: 24months
Secondary outcomes (10)
Comparing local recurrence rates between patients receiving Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)
Measured: 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)
Measured: 120 months
Comparing clinical and planning target volumes (CTV and PTV volumes) for CT-based planning vs. MRI-based planning
Measured: 60 months
Comparing patient reported cosmetic outcomes between patients treated on Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)
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.
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start3 Apr 2023
- Primary completion6 Sep 2026
- Study completion1 Jul 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 3 two-armed randomized clinical trial for localized favorable breast cancer patients, randomizing to CT-based radiation treatment vs. MRI-based radiation treatment
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Ng, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731791
- Sponsor's protocol ID
- 22-01024342
- Acronym
- PPI
- Status last verified
- Oct 2026
- First submitted
- 7 Feb 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial to Compare MRI-guided Precision Prone Irradiation (PPI) Versus CT-guided Breast Irradiation
- ClinicalTrials.gov ID
- NCT05731791
- Acronym / sponsor ID
- PPI / 22-01024342
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 6 Sep 2026 (actual)
- Study completion
- 1 Jul 2034 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 3 two-armed randomized clinical trial for localized favorable breast cancer patients, randomizing to CT-based radiation treatment vs. MRI-based radiation treatment
| Arm | Type | Receives |
|---|---|---|
| ARM 1 - CT-based breast radiation treatment | Active comparator | Radiation: Radiation Therapy to partial breastPatients randomized to ARM 1 will receive 3000 cGy in 5 fractions partial breast radiotherapy with CT-based breast radiation treatment. |
| ARM 2 - MRI-based breast radiation treatment | Active comparator | Radiation: Radiation Therapy to partial breastPatients randomized to ARM 2 will receive 3000 cGy in 5 fractions partial breast radiotherapy with MRI-based breast radiation treatment. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation Therapy to partial breastPatients 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). | Radiation | ARM 1 - CT-based breast radiation treatment, ARM 2 - MRI-based breast radiation treatment |
Primary outcome
Comparing local recurrence rates between patients receiving Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)
Time frame: 24months
10 secondary outcomes
Comparing local recurrence rates between patients receiving Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)
Time frame: 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)
Time frame: 120 months
Comparing clinical and planning target volumes (CTV and PTV volumes) for CT-based planning vs. MRI-based planning
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)
Time frame: 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)
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)
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)
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)
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)
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)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Ng, M.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation Therapy to partial breast in people with Breast Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing local recurrence rates between patients receiving Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2) (time frame: 24months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.