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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
CMPE Optical Sensor Device
Sponsored by
Sally Falk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CMPE Optical Sensor Device

Arm Description

Single arm study

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 18, 2014
Last Updated
February 22, 2018
Sponsor
Sally Falk
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1. Study Identification

Unique Protocol Identification Number
NCT02068378
Brief Title
Visual Feedback With Optical Sensing - A Feasibility Study
Acronym
ROSS-LC
Official Title
Clinical Evaluation of Visual Feedback With Optical Sensing in Lung Cancer Patients Undergoing Radiotherapy: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 30, 2014 (Actual)
Primary Completion Date
February 28, 2016 (Actual)
Study Completion Date
February 28, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sally Falk

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CMPE Optical Sensor Device
Arm Type
Experimental
Arm Description
Single arm study
Intervention Type
Device
Intervention Name(s)
CMPE Optical Sensor Device
Intervention Description
Christie Medical Physics & Enginieering visual feedback with optical sensing device.
Primary Outcome Measure Information:
Title
Tolerability of the device assessed as the percentage of patients who complete all 3 study sessions
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Reduction of periodic respiratory motion body surface amplitude using the device as compared to free breathing.
Time Frame
6 months
Title
Reduction of overall body surface variability using the device as compared to free breathing.
Time Frame
6 months
Title
Reduction in internal tumour motion magnitude and variability using the device as compared to free-breathing.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gareth Price, PhD
Organizational Affiliation
The Christie NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Christie NHS Foundation Trust
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Visual Feedback With Optical Sensing - A Feasibility Study

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