Visual Feedback With Optical Sensing - A Feasibility Study (ROSS-LC)

Clinical Evaluation of Visual Feedback With Optical Sensing in Lung Cancer Patients Undergoing Radiotherapy: 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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Device: CMPE Optical Sensor Device

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M20 4BX
      • The Christie NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CMPE Optical Sensor Device; Single arm study	Device: CMPE Optical Sensor Device; Christie Medical Physics & Enginieering visual feedback with optical sensing device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tolerability of the device assessed as the percentage of patients who complete all 3 study sessions	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction of periodic respiratory motion body surface amplitude using the device as compared to free breathing.	6 months
Reduction of overall body surface variability using the device as compared to free breathing.	6 months
Reduction in internal tumour motion magnitude and variability using the device as compared to free-breathing.	6 months

Collaborators and Investigators

• Sponsor: Sally Falk
• Investigators: Principal Investigator: Gareth Price, PhD, The Christie NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2014
• Primary Completion (Actual): February 28, 2016
• Study Completion (Actual): February 28, 2016

Study Registration Dates

• First Submitted: February 18, 2014
• First Submitted That Met QC Criteria: February 19, 2014
• First Posted (Estimate): February 21, 2014

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 13_DOG07_158; CFTSp076 (Other Identifier: The Christie NHS Foundation Trust)