NCT04270890

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

January 5, 2021

Status Verified

February 1, 2020

Enrollment Period

3.5 years

First QC Date

February 11, 2020

Last Update Submit

January 4, 2021

Conditions

Cancer, LungCancer of Stomach

Keywords

ablative stereotactic radiotherapy,lung cancercompression device

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Secondary Outcomes (1)

  • Reported patient feedback regarding device comfort and compliance of use.

    2 years

Study Arms (1)

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.

Device: Abdominal compression belt system

Interventions

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 participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clatterbridge Cancer Centre NHS Foundation Trust

Bebington, CH634JY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsStomach Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Anoop Haridass, MD

    Clatterbridge Cancer Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Maguire, PhD

CONTACT

0151 556maria.maguire2@nhs.net

David Price

CONTACT

0151 556david.price9@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 17, 2020

Study Start

June 21, 2018

Primary Completion

December 30, 2021

Study Completion

April 30, 2022

Last Updated

January 5, 2021

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)