Clinical trial · Interventional
Trial to Compare MRI-guided Precision Prone Irradiation (PPI) Versus CT-guided Breast Irradiation
A Prospective Randomized Trial to Compare MRI-guided Precision Prone Irradiation (PPI) Versus CT-guided Breast Irradiation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy to partial breast | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ARM 1 - CT-based breast radiation treatment
- description
- Patients randomized to ARM 1 will receive 3000 cGy in 5 fractions partial breast radiotherapy with CT-based breast radiation treatment.
- interventionNames
- Radiation: Radiation Therapy to partial breast
- type
- ACTIVE_COMPARATOR
- label
- ARM 2 - MRI-based breast radiation treatment
- description
- Patients randomized to ARM 2 will receive 3000 cGy in 5 fractions partial breast radiotherapy with MRI-based breast radiation treatment.
- interventionNames
- Radiation: Radiation Therapy to partial breast
Primary outcomes (1)
- measure
- Comparing local recurrence rates between patients receiving Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available