Cancer, LungACE02NCT04270890
Investigation of an Abdominal Compression Device
A study testing Abdominal compression belt system in people with Cancer, Lung and Cancer of Stomach, run by The Clatterbridge Cancer Centre NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study is applicable to patients undergoing lower lung or abdomen stereotactic ablative body radiotherapy (SABR) treatment. The purpose of the ACE 01 study is to identify if, the volume of healthy tissue within the treatment area and therefore subsequent side effects, can be reduced by using a commercially… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Lung, Cancer of Stomach
- What is being tested?
- Abdominal compression belt system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jun 2018to 30 Apr 2022
- 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
- • Radiological or Histologically confirmed lower lobe lung cancer or histologically confirmed metastatic of primary cancer in abdominal organs including liver, pancreas, adrenal which meets criteria for SABR treatment.
- Aged 18 years or over
- Capacity to understand research proposal and give informed consent
Who cannot join
- Tumour sites excluding those previously defined
- Rib metastases
- Stoma if situated underneath belt
- Patients unable to tolerate the abdominal compression belt
- Patients with existing abdominal aortic aneurysm (AAA)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Clatterbridge Cancer Centre NHS Foundation Trust
Bebington, CH634JY
Maria Maguire, PhD, 0151 556 ext. 5321, maria.maguire2@nhs.net
David Price, 0151 556 ext. 5906, david.price9@nhs.net
About this study
Official title: Analysis of an Abdominal Compression Device to Reduce Respiratory Motion of Lower Thorax and Abdominal Tumours
This study is applicable to patients undergoing lower lung or abdomen stereotactic ablative body radiotherapy (SABR) treatment. The purpose of the ACE 01 study is to identify if, the volume of healthy tissue within the treatment area and therefore subsequent side effects, can be reduced by using a commercially available abdominal compression device to minimise breathing related movement. The secondary aim will be to assess patient compliance and comfort of thedevice. This will be assessed by asking the patient to complete a 'patient comfort questionnaire'. In addition the radiographers will be asked to complete a 'satisfaction questionnaire' to determine ease and reproducibility of use.
Read the detailed description
Stereotactic ablative body radiotherapy (SABR) offers the ability to deliver a high dose of radiotherapy accurately to small tumours. It is an established, effective, non-invasive treatment option for early lung cancers as an alternative to surgery and in the treatment of limited spread of cancer (called oligo-metastatic disease) in the context of clinical trials (CORE, SARON, ABC-07 etc.). In order to deliver a high dose of radiation without damaging the surrounding structures, an accurate map of the tumour and the surrounding organs and their relationship to each other when moving (for e.g. during breathing) is important. This is usually achieved by getting a radiotherapy treatment planning 4 dimensional CT scan (4D-CT). When either the tumour or organ around them (like the lung) are moving excessively it becomes difficult to target the radiation beams and often the only solution is to treat a larger volume which covers the extent of the movement. Treating larger volumes often leads to more toxicity to the surrounding tissues.Therefore managing motion is critical to increasing tumour control probability (TCP) and reducing normal tissue complication probability (NTCP). In this context, the question of reducing the movement caused by breathing, of tumours in the lower lung and upper abdomen (like the liver, adrenals, kidney etc) is an area of intense interest. Various technical and physical methods exist to help improve motion management in patients under going radiotherapy. By limiting the movement, the target volume is smaller and this enables treatment of the tumour to high doses with lesser toxicity as some of the toxicity of radiotherapy is proportionate to the volume treated i.e. lower the volume of treatment lesser the risk of toxicity.
Abdominal compression is one such method and is well accepted to be beneficial in reducing tumour motion.
However, many of the previous studies require expensive and resource intensive immobilisation devices, costing, in many cases in excess of £10,000. This study will investigate the use of an independent compression device which can be used with any existing immobilisation system and costs in the region of £1,500. If proven to be beneficial this will allow many smaller centres or centres with budget limitations to also achieve the benefits of abdominal compression without extensive resource and cost requirements.
- Conditions
- Cancer, Lung, Cancer of Stomach
- Being tested
- Abdominal compression belt system
- Keywords
- ablative stereotactic radiotherapy,, lung cancer, compression device
- Medical subject headings
- Lung Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal compression belt systemDevice
The abdominal compression belt system is provided free of charge from CDR systems, Canada.
The belt has specifically been chosen from other similar devices commercially available as it is independent of other immobilisation devices and can be used with the patient located within a full body vacbag as per current immobilisation position.
| Study group | Role | What they receive |
|---|---|---|
| Study participants | Experimental | Patients will be dual scanned; one with 4D-CT in free-breathing and one wearing the compression belt.Organ motion will then be quantified using Eclipse. This facilitates a direct comparison to determine the efficacy of the compression belt. Patients with reduction in organ motion will be treated wearing the abdominal compression belt. The alignment scale will be recorded to facilitate accurate placement each fraction. The belt will be inflated to a tolerable level by the patient and recorded for consistency each fraction. The position of the belt will be referenced to the anterior and lateral tattoos to ensure accurate and consistent placement each fraction. Receives: Device: Abdominal compression belt system |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure change in treatment volume between freebreathing and abdominal compression scans
Organ motion will then be quantified using Eclipse. This facilitates a direct comparison to determine the efficacy of the compression belt. Patients with reduction in organ motion will be treated wearing the abdominal compression belt. The alignment scale will be recorded to facilitate accurate placement each fraction.
compression belt
Measured: 2 years
Secondary outcomes (1)
Reported patient feedback regarding device comfort and compliance of use.
The comfort of the device in clinical use will be measured by using a questionnaire that the patient will be asked to complete at initial scanning and then on two subsequent treatments. The results will be collated and analysed to qualitatively measure patient comfort and use of the device
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start21 Jun 2018
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, LungStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Clatterbridge Cancer Centre NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anoop Haridass, MD, Principal investigator, Clatterbridge Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270890
- Sponsor's protocol ID
- CO966
- Acronym
- ACE02
- Status last verified
- Feb 2020
- First submitted
- 11 Feb 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of an Abdominal Compression Device to Reduce Respiratory Motion of Lower Thorax and Abdominal Tumours
- ClinicalTrials.gov ID
- NCT04270890
- Acronym / sponsor ID
- ACE02 / CO966
- Conditions
- Cancer, Lung, Cancer of Stomach
- Keywords
- ablative stereotactic radiotherapy,, lung cancer, compression device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Clatterbridge Cancer Centre NHS Foundation TrustUniversity, hospital or other
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 17 Feb 2020 (actual)
- 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.
This study is applicable to patients undergoing lower lung or abdomen stereotactic ablative body radiotherapy (SABR) treatment. The purpose of the ACE 01 study is to identify if, the volume of healthy tissue within the treatment area and therefore subsequent side effects, can be reduced by using a commercially available abdominal compression device to minimise breathing related movement. The secondary aim will be to assess patient compliance and comfort of thedevice. This will be assessed by asking the patient to complete a 'patient comfort questionnaire'. In addition the radiographers will be asked to complete a 'satisfaction questionnaire' to determine ease and reproducibility of use.
Detailed description
Stereotactic ablative body radiotherapy (SABR) offers the ability to deliver a high dose of radiotherapy accurately to small tumours. It is an established, effective, non-invasive treatment option for early lung cancers as an alternative to surgery and in the treatment of limited spread of cancer (called oligo-metastatic disease) in the context of clinical trials (CORE, SARON, ABC-07 etc.). In order to deliver a high dose of radiation without damaging the surrounding structures, an accurate map of the tumour and the surrounding organs and their relationship to each other when moving (for e.g. during breathing) is important. This is usually achieved by getting a radiotherapy treatment planning 4 dimensional CT scan (4D-CT). When either the tumour or organ around them (like the lung) are moving excessively it becomes difficult to target the radiation beams and often the only solution is to treat a larger volume which covers the extent of the movement. Treating larger volumes often leads to more toxicity to the surrounding tissues.Therefore managing motion is critical to increasing tumour control probability (TCP) and reducing normal tissue complication probability (NTCP). In this context, the question of reducing the movement caused by breathing, of tumours in the lower lung and upper abdomen (like the liver, adrenals, kidney etc) is an area of intense interest. Various technical and physical methods exist to help improve motion management in patients under going radiotherapy. By limiting the movement, the target volume is smaller and this enables treatment of the tumour to high doses with lesser toxicity as some of the toxicity of radiotherapy is proportionate to the volume treated i.e. lower the volume of treatment lesser the risk of toxicity.
Abdominal compression is one such method and is well accepted to be beneficial in reducing tumour motion.
However, many of the previous studies require expensive and resource intensive immobilisation devices, costing, in many cases in excess of £10,000. This study will investigate the use of an independent compression device which can be used with any existing immobilisation system and costs in the region of £1,500. If proven to be beneficial this will allow many smaller centres or centres with budget limitations to also achieve the benefits of abdominal compression without extensive resource and cost requirements.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study participants | Experimental | Device: Abdominal compression belt systemPatients will be dual scanned; one with 4D-CT in free-breathing and one wearing the compression belt.Organ motion will then be quantified using Eclipse. This facilitates a direct comparison to determine the efficacy of the compression belt. Patients with reduction in organ motion will be treated wearing the abdominal compression belt. The alignment scale will be recorded to facilitate accurate placement each fraction. The belt will be inflated to a tolerable level by the patient and recorded for consistency each fraction. The position of the belt will be referenced to the anterior and lateral tattoos to ensure accurate and consistent placement each fraction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Radiological or Histologically confirmed lower lobe lung cancer or histologically confirmed metastatic of primary cancer in abdominal organs including liver, pancreas, adrenal which meets criteria for SABR treatment.
Key exclusion criteria (5 listed)
- Tumour sites excluding those previously defined
- Rib metastases
- Stoma if situated underneath belt
- Patients unable to tolerate the abdominal compression belt
- Patients with existing abdominal aortic aneurysm (AAA)
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 |
|---|---|---|
| Abdominal compression belt systemThe abdominal compression belt system is provided free of charge from CDR systems, Canada. The belt has specifically been chosen from other similar devices commercially available as it is independent of other immobilisation devices and can be used with the patient located within a full body vacbag as per current immobilisation position. | Device | Study participants |
Primary outcome
To measure change in treatment volume between freebreathing and abdominal compression scans
Time frame: 2 years
Organ motion will then be quantified using Eclipse. This facilitates a direct comparison to determine the efficacy of the compression belt. Patients with reduction in organ motion will be treated wearing the abdominal compression belt. The alignment scale will be recorded to facilitate accurate placement each fraction. compression belt
1 secondary outcome
Reported patient feedback regarding device comfort and compliance of use.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Anoop Haridass, MD principal investigator
Clatterbridge Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal compression belt system in people with Cancer, Lung and Cancer of Stomach, run by The Clatterbridge Cancer Centre NHS Foundation Trust 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Maguire, PhD (0151 556 ext. 5321, maria.maguire2@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure change in treatment volume between freebreathing and abdominal compression scans (time frame: 2 years). 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 5 Jan 2021; AzTrials last refreshed its copy on 6 Nov 2026.