Clinical trial · Interventional
CARA Treatment Pilot Study for Breast Positioning
NCT04543851CI-TRIAL-00047060completedN/AClinicalTrials.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)
CARA is a novel Carbon-fibre Adjustable and Re-usable Accessory for supine breast positioning during radiation therapy. CARA was developed at BC Cancer. In this study, twenty patients will be planned and treated with CARA positioning to establish safety and workflow measures of this novel device. The device is designed to remove the infra-mammary skin fold and lateral breast droop which can lead to unwanted dose to normal tissue.
Conditions
Conditions (2)
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 |
| Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CARA - carbon fibre adjustable re-usable accessory for breast positioning | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CARA positioning
- description
- Planning and Treatment using the CARA Device
- interventionNames
- Device: CARA - carbon fibre adjustable re-usable accessory for breast positioning
Primary outcomes (3)
- measure
- Number of participants for whom dose volume treatment planning constraints are not met using CARA support for breast setup
- timeFrame
- 12 months
- description
- Treatment planning dose constraints are: \>=95% of the prescribed dose covering \>=98% of the breast target tissue, including internal mammary chain when requested by the treating oncologist volume of ipsi-lateral lung receiving \>= 20Gy should be \<=35% volume of heart receiving \>=25Gy should be \<=5% maximum dose to any point in the body \<=110% of the prescribed dose volume of breast receiving \>=107% of prescribed dose should be \<=22 cm\^3
- measure
- Number of participants having measured breast skin dose => 110% of the prescribed dose to an area of skin => 1 cm^2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: Patients diagnosed with completely excised stage I or II invasive breast cancer, or ductal carcinoma in situ (DCIS), who have undergone breast-conserving surgery and are scheduled to undergo adjuvant breast radiotherapy; Any breast size with a skin fold of depth 1 cm or greater at the infra-mammary crease at the time of radiation treatment planning, or brassiere cup size equal to or larger than D; Patients undergoing nodal radiotherapy are eligible if the above criteria are met; Patients undergoing boost radiotherapy are eligible if the above criteria are met, but only if the surgical scar does not extend inferior to the nipple line of the breast; Language is not a barrier if there are interpreters/family members to translate; Patients having had chemotherapy are eligible for this study; Exclusion Criteria: Inability to give informed consent or comply with requirements of the trial; Failure of healing of the surgical scar or significant post-operative wound infection; Prior radiotherapy to either breast or to the chest; Presence of significant connective tissue disease (e.g. systemic sclerosis); known radiation hypersensitivity phenotype (e.g. ataxia telangiectasia); Inability to return for assessment at both one week and two weeks following completion of radiotherapy; Breast reconstruction; Use of Mepitel® wound dressing product.
References
Publications (2)
- DERIVEDMalhotra A, Chan EK, Nichol A, Duzenli C. Spatial dose-distribution-based risk mapping to predict moist desquamation in breast radiotherapy. Phys Med Biol. 2025 May 27;70(11). doi: 10.1088/1361-6560/add985. PMID 40373801
- DERIVEDDuzenli C, Koulis T, Menna T, Carpentier E, Arora T, Coope R, Gill B, Lim P, Aquino-Parsons C, Nichol A, Singer J, Ingledew PA, Grahame S, Chan EK. Reduction in Doses to Organs at Risk and Normal Tissue During Breast Radiation Therapy With a Carbon-Fiber Adjustable Reusable Accessory. Pract Radiat Oncol. 2021 Nov-Dec;11(6):470-479. doi: 10.1016/j.prro.2021.06.012. Epub 2021 Jul 21. PMID 34303034