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NCT Number: NCT02068378

Visual Feedback With Optical Sensing - A Feasibility Study

Lung cancer is the second most common cancer in the United Kingdom with around 40,000 new cases diagnosed every year. Lung cancer is associated with a very poor prognosis (<10% patient survival at 5 years). New strategies are urgently needed to improve survival in this group of patients.

The most effective and common treatment for lung cancer is radiotherapy (either alone or combined with chemotherapy and/or surgery) and generally high doses of radiotherapy are given to the tumour. However, increasing the radiotherapy dose carries an increased risk of damage to the surrounding healthy tissue. Damage can be minimised by reducing movement within the lung, caused by factors such as breathing and patient motion, during treatment.

This study tests a new medical device that has been developed to monitor and help patients control their breathing and movement during treatment. Optical sensors will detect any motion of the patient's torso and this will be fed back to the patient in the form of a visual aid allowing them to regulate their breathing and maintain their ideal treatment position.

The device has already been shown to reduce motion in healthy volunteers. In this study the investigators hope to demonstrate that the visual aids are tolerable in lung cancer patients. The investigators additionally aim to show the device will help reduce movements of the chest and also the lung tumour, leading to improvements in treatment results.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Christie NHS Foundation Trust

Manchester, Greater Manchester, M20 4BX, United Kingdom

About this study

In this study each participant will undergo 4 imaging sessions (one training session and 3 study sessions) where participants will be asked to use the optical feedback display to regulate breathing patterns.

The training session and each study session will proceed as follows:

  • The patient receives standard treatment including any pre-treatment Cone Beam CT (CBCT) imaging.
  • The patient is allowed to get up off the treatment couch and relax whilst the sensor device is turned on.
  • The patient is set-up again.
  • The patient is asked to free-breathe (i.e. breathe normally) and the surface motion is recorded using the optical sensor. The first 30 seconds are used to generate the reference surface used throughout the rest of the process. A 4D CBCT scan is acquired during free-breathing to assess tumour motion.
  • The patient is then asked to control their breathing using the feedback displays and data is recorded for ~1:30 minutes in each case.
  • A 4D CBCT scan will be acquired during controlled breathing with the traffic light feedback visualization scheme to assess tumour motion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stage 1-3 lung cancer (Non Small Cell Lung Cancer and Small Cell Lung Cancer; histological diagnosis not mandatory) including at least 5 patients with lower lobe tumours
  • Suitable for radical radiotherapy
  • Tumour judged inoperable by a thoracic surgeon
  • At least 18 years old

Exclusion criteria

  • Stage 4 Non Small Cell Lung Cancer
  • Unable to give informed consent
  • Epilepsy or migraine

Treatment and study plan

CMPE Optical Sensor Device

Device

Christie Medical Physics & Enginieering visual feedback with optical sensing device.

Primary outcomes

  1. Tolerability of the device assessed as the percentage of patients who complete all 3 study sessions

    Time frame: 6 months

Secondary outcomes

  1. Reduction of periodic respiratory motion body surface amplitude using the device as compared to free breathing.

    Time frame: 6 months

  2. Reduction of overall body surface variability using the device as compared to free breathing.

    Time frame: 6 months

  3. Reduction in internal tumour motion magnitude and variability using the device as compared to free-breathing.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Sally Falk

Other

Registry information

Official study title

Clinical Evaluation of Visual Feedback With Optical Sensing in Lung Cancer Patients Undergoing Radiotherapy: A Feasibility Study

Acronym: ROSS-LC

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 21, 2014
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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