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NICE Develops Medtech Innovation Briefing on AlignRT in Breast Cancer Radiotherapy

The briefing focuses on AlignRT patient position monitoring system use during breast cancer radiation therapy
18 Sep 2018
Breast cancer

In August 2018, the NICE has published a medtech innovation briefing (MIB) on AlignRT in breast cancer radiotherapy. The innovative aspect of AlignRT system is that it may avoid inaccurate treatment by precisely tracking a patient's position during radiotherapy and notifying the linear accelerator to hold the radiation beam if the patient moves. 

The intended place in therapy would be in a standard radiation treatment room with a linear accelerator. It would be used as an alternative to existing patient location monitoring systems using X‑ray/CT and as an adjunct to radiographer visual monitoring of patient movement. 

The main points from the evidence summarised in this briefing are from 4 observational studies involving a total of 228 adults in tertiary care settings in the US and Europe. They suggest that AlignRT is effective in maintaining accurate patient positioning during breast cancer radiotherapy. 

Key uncertaintiesare that there is no evidence from direct comparisons of AlignRT with location monitoring or from studies specifically using AlignRT as the main intervention. 

The cost of AlignRT is 150,000 GBP to 225,000 GBP per unit (excluding VAT), plus a yearly service charge of 20,000 GBP. The cost per treatment will depend on the throughput per device for the variety of radiotherapy procedures the device can be used for. 

AlignRT was CE marked as a class IIb device in June 2016. 

Between 2014 and 2016, there were 4 manufacturer field safety notices or medical device alerts for AlignRT. All were resolved, including through product upgrades. 

This briefing focuses on AlignRT (Vision RT) uses in breast radiotherapy. The NICE has published in May 2018 a MIB on the use of AlignRT in intracranial stereotactic radiosurgery

If AlignRT detects any patient movement during treatment, it can instruct the linear accelerator to stop the radiation beam, or prompt the user to manually pause treatment. This is intended to prevent radiation being delivered to neighbouring tissue and organs, which can lead to unwanted side effects and ineffective treatment. 

Monitoring and maintaining a patient's position is especially important when treating the breast (particularly the left breast), because movements from breathing can result in unintended irradiation. AlignRT can position and monitor the patient with the couch and gantry at different angles. AlignRT also tracks the entire patient surface, whereas most similar devices only monitor a few points. 

Location monitoring during radiotherapy varies and the best approach is decided by a multidisciplinary team. Patients are positioned using standard CT and X‑ray systems so that any movement is minimised. A range of breath-holding techniques and devices may also be used to ensure that the correct lung volume is maintained when the patient holds their breath. The Royal College of Radiologists UK consensus statements on post-operative radiotherapy for breast cancer (2016) notes that in patients with left-sided breast cancer, the heart should routinely be spared from the radiotherapy field. In addition, the statement notes that breath-hold techniques should be available in all UK radiotherapy departments. 

NICE is aware of the following CE-marked devices that appear to fulfil a similar function to AlignRT: 

  • Catalyst (C‑Rad)
  • Identify (HumediQ)
  • Active Breathing Coordinator (Elekta)
  • Real-Time Position Management System (Varian) 

AlignRT would be used for patients with breast cancer in whom radiotherapy is suitable. Radiotherapy would be done in specialist tertiary centres and AlignRT would be used by an appropriately trained therapy radiographer. 

AlignRT is currently used in some NHS centres during radiotherapy for breast cancer.

Last update: 18 Sep 2018

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