Collection of Head Images During Radiotherapy

NCT05218824 | Active Not Recruiting

• 1 other identifier: IX-2021-P0-CHIRP
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this observational study is to quantify the translation, rotation, and deformation of patient head positions of head and neck cancer patients over the course of a radiation therapy treatment for head and neck cancer. This objective will be achieved by comparing X-ray images collected during each treatment session with those obtained from the planning CT scan. Secondary objectives include (1) the use of the collected X-ray images to develop realistic artificial X-ray images where patient movement can be simulated and (2) to determine whether motion can be detected from individual X-ray images acquired during radiation therapy treatment.

Conditions

Head and Neck Neoplasms; Radiation Therapy Complication

Outcome Measures

Primary Outcomes (3)

• Translational head motion between different radiation therapy treatment sessions

  Translation error (mm)

  8 weeks

• Rotational head motion between different radiation therapy treatment sessions

  Rotation error (degree)

  8 weeks

• Head deformation between different radiation therapy treatment sessions

  Deformation error (mm)

  8 weeks

Secondary Outcomes (2)

• Difference in structural similarity (SSIM) indexes between artificial and real X-rays

  8 weeks

• Difference in mean absolute error between artificial and real X-rays

  8 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants undergoing radiation therapy at Blacktown Hospital for head and neck cancer using a thermoplastic immobilisation mask

You may qualify if:

• A diagnosis of head and neck cancer (any stage)
• Age 18 years or greater
• Receiving radiation therapy to the head and neck with a thermoplastic immobilisation mask
• An ECOG score in the range of 0 to 2
• Any other prior or concurrent therapy allowed

You may not qualify if:

• People with cognitive impairment which would preclude them from providing informed consent
• People who are unable to speak and read English and for whom obtaining consent would be difficult.

Sponsors & Collaborators

• University of Sydney: lead
• Western Sydney Local Health District: collaborator

Study Sites (1)

Blacktown Hospital

Blacktown, New South Wales, 2148, Australia

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Paul Keall, PhD

  University of Sydney

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: February 1, 2022
• Study Start: February 14, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After study completion and publication, indefinitely.
• Access Criteria: Data stored at the university: (i) that the data is not to be published or otherwise redistributed without the express consent of the original investigator(s) and (ii) that the data is forbidden to be used for any commercial purpose and (iii) the research is approved by an accredited ethics committee. Data stored at an external repository: Study data that are provided to an external research data repository will be stored at and managed by the external repository. Data will only be shared with repositories whose function has been reviewed and approved by an accredited Research Integrity/Ethics Committee/Board under a Materials Transfer Agreement with the university.

Locations

AU (1)