Clinical trial · Interventional
Use of the Contura™ Catheter to Deliver Accelerated Partial Breast Irradiation to "Low-risk" Breast Cancer Patients
A Multi-Site, Prospective, Non-Randomized Study of the Contura™ Multi-Lumen Balloon (MLB) Catheter to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetry, Local Tumor Control, Cosmetic Outcome, and Toxicity
NCT00882596CI-TRIAL-00031368completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this national, multi-site study is to determine the safety and effectiveness of the Contura catheter in breast cancer patients undergoing accelerated partial breast irradiation.
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 |
|---|---|---|---|
| Accelerated partial breast irradiation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Contura accelerated partial breast irradiation. Following a lumpectomy, a Contura balloon catheter is placed in the lumpectomy cavity. Later that morning, accelerated partial breast irradiation begins.
- interventionNames
- Device: Accelerated partial breast irradiation
Primary outcomes (1)
- measure
- Maximum total skin dose is less than or equal to 125% of the prescribed radiation dose.
- timeFrame
- 19 months
Secondary outcomes (1)
- measure
- Toxicity rates
- timeFrame
- 79 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Able and willing to sign informed consent * Age 50 or older at diagnosis * Life expectancy greater than 10 years (excluding diagnosis of breast cancer) * Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (negative surgical margins per NSABP criteria) * On histologic examination, the tumor must be DCIS and/or invasive breast carcinoma * For patients with invasive breast cancer, an axillary staging procedure must be performed \[either sentinel node biopsy or axillary dissection (with a minimum of 6 axillary nodes removed), and the axillary node(s) must be pathologically negative\] * The T stage must be Tis, T1, or T2. If T2, the tumor must be less than or equal to 3.0 cm in maximum diameter * Estrogen receptor positive tumor Exclusion Criteria: * Age \< 50 at diagnosis (regardless of histology) * Pregnant or breast-feeding * Active collagen vascular disease * Paget's disease of the breast * Prior history of DCIS or invasive breast cancer * Prior breast or thoracic radiation therapy for any condition * Multicentric carcinoma (DCIS or invasive) * Synchronous bilateral invasive or non-invasive breast cancer * Surgical margins that cannot be microscopically assessed or that are positive * Positive axillary node(s) * T stage of T2 with the tumor \> 3 cm in maximum diameter or a T stage of T3 or T4 * Estrogen receptor negative tumor
References
Publications (0)
Data not yet available
No reference posted for this study.