An interventional study of AlignRT system (VisionRT Ltd., London, UK) in Left-Sided Breast Cancer, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-05.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Treatment
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The standard treatment for breast cancer is surgery followed by adjuvant breast radiation therapy in most cases. For left sided breast cancers, the heart dose delivered by the radiation treatment is often of particular concern. In order to spare the heart, different strategies are currently available, including active breathing control (ABC) and voluntary deep in inspiration breath hold (DIBH) (both strategies are currently being used at our centre). To perform accurate heart-sparing treatments, it is important to ensure that patients are positioned consistently. One available approach is through surface imaging which tracks the position of a portion of the skin surface, known as the AlignRT system (VisionRT Ltd, London, UK).
16 studies on the registry are indexed under Unilateral Breast Neoplasms; 3 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 13 interventional studies indexed under Unilateral Breast Neoplasms.
Browse Unilateral Breast Neoplasms studies →Sunnybrook Health Sciences Centre is the lead sponsor of 584 studies on the registry; 135 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Exclusion Criteria:
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Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To review our institutional clinical experience of applying the AlignRT system to monitor patient setup and reproducibility when using ABC and DIBH techniques in the treatment of left-sided breast cancer patients.
Device: AlignRT system (VisionRT Ltd., London, UK)
To review our institutional clinical experience of applying the AlignRT system to monitor patient setup and reproducibility when using ABC and DIBH techniques in the treatment of left-sided breast cancer patients.
Device: AlignRT system (VisionRT Ltd., London, UK)
To review our institutional clinical experience of applying the AlignRT system to monitor patient setup and reproducibility when using ABC and DIBH techniques in the treatment of left-sided breast cancer patients.
Reproducibility of ABC or vDIBH set-up as measured by Align RT.
Reproducibility of set-up will be evaluated by determining discrepancies in patient's surface between treatment and CT simulation which will be acquired with the Align RT system using multiple measures along with daily portal images during treatment and weekly CBCTs.
Time frame: 2 years
Mean heart dose as determined using Align RT.
Estimate the change in mean heart dose for each breath-hold/heart sparing strategy by: i. Converting differences in heart position on 2D portal images acquired during treatment to 3D volumes on Pinnacle plans. ii. Using the CBCT images (acquired weekly), to recalculate dose to heart based on the patient's position and anatomy that day.
Time frame: 2 years
The impact of Align RT with vDIBH as compared to vDIBH without AlignRT on quality of life as assessed by the EORTC core QoL questionnaire.
QoL will be assessed using the EORTC core QoL questionnaire (QLQ-C30) which is a well-validated and widely used QoL questionnaire available in multiple languages (12,13). QLQ-C30 is composed of 30 questions that represent 5 functional scales (physical, role, cognitive, emotional and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), and a global health / QoL scale. The questionnaire will be completed by patients at time of radiation simulation as baseline, at completion of RT (during routine review) and at the 6-8 week follow-up.
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Dec 2021, 43 months.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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