Trials / Completed
CompletedNCT04543851
CARA Treatment Pilot Study for Breast Positioning
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- British Columbia Cancer Agency · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This pilot study will investigate the safety and potential benefits of CARA breast positioning by treating 20 patients using the device. Patients will be planned with CARA positioning and standard of care positioning. CARA plans will be evaluated to ensure all treatment planning goals are met and patients will proceed to treatment with CARA positioning. This pilot study will ensure that patients can be safely treated with the CARA and provide us with valuable information from therapists, oncologists and patients about the performance of the current design. This will also inform the direction of design improvements and the production of educational materials for training practitioners in the use of the device. Overall, this will prepare us for a randomized clinical trial of the CARA positioning technique versus current standard of practice to assess whether reduced toxicity can be achieved using the CARA technique.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CARA - carbon fibre adjustable re-usable accessory for breast positioning | Breast positioning to alleviate infra-mammary fold and lateral breast sag |
Timeline
- Start date
- 2018-10-08
- Primary completion
- 2019-11-04
- Completion
- 2019-11-18
- First posted
- 2020-09-10
- Last updated
- 2020-09-10
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT04543851. Inclusion in this directory is not an endorsement.