Clinical trial · Interventional
Radiation Therapy Planning Techniques in Reducing Damage to Normal Tissue in Women Undergoing Breast-Conserving Surgery for Ductal Carcinoma of the Breast
WILL MULTIFUNCTIONAL MAGNETIC RESONANCE TECHNIQUES, DETAILED HISTOPATHOLOGICAL ANALYSIS AND PRONE TREATMENT POSITION IMPROVE ACCURACY OF TARGET VOLUME LOCALISATION & DEFINITION AND REDUCE EXPOSURE OF NORMAL TISSUES IN BREAST RADIOTHERAPY?
- 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)
RATIONALE: Diagnostic procedures, such as multifunctional magnetic resonance imaging and CT scans, may help reduce normal tissue damage in patients undergoing radiation therapy for cancer. PURPOSE: This clinical trial is studying how well radiation therapy planning techniques work in reducing damage to normal tissue in women undergoing breast-conserving surgery for ductal breast carcinoma.
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 (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| biopsy | Procedure | — | UNRESOLVED |
| computed tomography | Procedure | — | UNRESOLVED |
| dynamic contrast-enhanced magnetic resonance imaging | Procedure | — | UNRESOLVED |
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Difference in lung NTDmean (biologically weighted [normalized] mean of total dose to lung normalized to 2 Gy fractions) in supine vs prone positions
Secondary outcomes (7)
- measure
- Closeness of agreement between MRI-based vs CT scan/clip- based delineation of tumor bed
- measure
- Closeness of agreement between clinical target volumes (CTVs) defined using uniform margin vs those defined using knowledge of all excision margins
- measure
- Difference in NTDmean to ipsilateral non-planning target volume (PTV) breast tissue, chest wall muscle, and heart
- measure
- Difference in mean volume of PTV in supine versus prone positions
- measure
- Difference in dose homogeneity within PTV in each position
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Planning to undergo breast-conserving surgery (BCS)\* for unifocal ductal carcinoma in situ (DCIS) or grade 1-2 invasive ductal carcinoma (IDC) of the breast NOTE: \*Patients who have underwent BCS and have titanium clips placed according to this protocol are eligible for this study. * No T4d or multifocal disease (as defined on mammography or ultrasound) * No G3 disease * Hormone receptor status not specified PATIENT CHARACTERISTICS: Inclusion criteria: * Female * Menopausal status not specified Exclusion criteria: * Cup size DD or greater * Ferromagnetic implants (exclude participation in MRI) * Claustrophobia (exclude participation in MRI) * Gadolinium allergy PRIOR CONCURRENT THERAPY: * No prior surgery to ipsilateral breast * No prior neoadjuvant chemotherapy
References
Publications (0)
Data not yet available