An interventional study of CMPE Optical Sensor Device in Lung Cancer, sponsored by Sally Falk. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-23.
Sponsored by Sally Falk · Not applicable, Interventional, and Other
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.
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:
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 16 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Sally Falk is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single arm study
Device: CMPE Optical Sensor Device
Christie Medical Physics \& Enginieering visual feedback with optical sensing device.
Tolerability of the device assessed as the percentage of patients who complete all 3 study sessions
Time frame: 6 months
Reduction of periodic respiratory motion body surface amplitude using the device as compared to free breathing.
Time frame: 6 months
Reduction of overall body surface variability using the device as compared to free breathing.
Time frame: 6 months
Reduction in internal tumour motion magnitude and variability using the device as compared to free-breathing.
Time frame: 6 months
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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