Lung CancerROSS-LCNCT02068378
Visual Feedback With Optical Sensing - A Feasibility Study
A study testing CMPE Optical Sensor Device in people with Lung Cancer, run by Sally Falk at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- CMPE Optical Sensor Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Apr 2014to 28 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Stage 4 Non Small Cell Lung Cancer
- Unable to give informed consent
- Epilepsy or migraine
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Christie NHS Foundation Trust
Manchester, Greater Manchester, M20 4BX
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- CMPE Optical Sensor Device
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMPE Optical Sensor DeviceDevice
Christie Medical Physics \& Enginieering visual feedback with optical sensing device.
| Study group | Role | What they receive |
|---|---|---|
| CMPE Optical Sensor Device | Experimental | Single arm study Receives: Device: CMPE Optical Sensor Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of the device assessed as the percentage of patients who complete all 3 study sessions
Measured: 6 months
Secondary outcomes (3)
Reduction of periodic respiratory motion body surface amplitude using the device as compared to free breathing.
Measured: 6 months
Reduction of overall body surface variability using the device as compared to free breathing.
Measured: 6 months
Reduction in internal tumour motion magnitude and variability using the device as compared to free-breathing.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study start30 Apr 2014
- Primary completion28 Feb 2016
- Study completion28 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sally Falk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sally Falk, The Christie NHS Foundation Trust
- Investigators
- Gareth Price, PhD, Principal investigator, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068378
- Sponsor's protocol ID
- 13_DOG07_158
- Other IDs
- CFTSp076
- Acronym
- ROSS-LC
- Status last verified
- Feb 2018
- First submitted
- 18 Feb 2014
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Visual Feedback With Optical Sensing in Lung Cancer Patients Undergoing Radiotherapy: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02068378
- Acronym / sponsor ID
- ROSS-LC / 13_DOG07_158
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sally FalkUniversity, hospital or other
- Study start
- 30 Apr 2014 (actual)
- Primary completion
- 28 Feb 2016 (actual)
- Study completion
- 28 Feb 2016 (actual)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMPE Optical Sensor Device | Experimental | Device: CMPE Optical Sensor DeviceSingle arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Stage 4 Non Small Cell Lung Cancer
- Unable to give informed consent
- Epilepsy or migraine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMPE Optical Sensor DeviceChristie Medical Physics \& Enginieering visual feedback with optical sensing device. | Device | CMPE Optical Sensor Device |
Primary outcome
Tolerability of the device assessed as the percentage of patients who complete all 3 study sessions
Time frame: 6 months
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gareth Price, PhD principal investigator
The Christie NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMPE Optical Sensor Device in people with Lung Cancer, run by Sally Falk at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of the device assessed as the percentage of patients who complete all 3 study sessions (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.