Visual Feedback With Optical Sensing - A Feasibility Study

NCT02068378 | Completed

• 2 other identifiers: 13_DOG07_158CFTSp076
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (3)

• 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

Study Arms (1)

CMPE Optical Sensor Device

EXPERIMENTAL

Single arm study

Device: CMPE Optical Sensor Device

Interventions

CMPE Optical Sensor Device DEVICE

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

CMPE Optical Sensor Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sally Falk: lead

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Gareth Price, PhD

  The Christie NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Trials Project Manager

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 21, 2014
• Study Start: April 30, 2014
• Primary Completion: February 28, 2016
• Study Completion: February 28, 2016
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

GB (1)