CHIRP: Collection of Head Images During Radiotherapy

Sponsor
University of Sydney (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05218824
Collaborator
Western Sydney Local Health District (Other)
30
1
12.4
2.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Participants will undergo their radiation therapy treatment for HNC as planned and per the routine clinical management protocol. As part of this routine treatment, multiple x-ray images will be acquired to assist in accurate positioning of the patient for their planned radiation therapy. Normally these images are stored for a few days and then discarded. This study will be collating, storing and analysing these images. These X-ray images will be paired with the corresponding pre-treatment CT scan that is routinely acquired for each patient, as well as the locations of organs of interest, such as the tumour and surrounding structures. The patient treatment plan will also be collated, as it will allow for analysis of how any motion affects the accuracy of dose delivery. The patient radiation treatment delivery record will be collected to help sort and categorise the acquired images. Information on potential confounding or interacting factors will be collected: demographic information will be collected including sex, age, tumour stage and histology.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Collection of Head Images During Radiotherapy (CHIRP)
    Anticipated Study Start Date :
    Feb 15, 2022
    Anticipated Primary Completion Date :
    Feb 28, 2023
    Anticipated Study Completion Date :
    Feb 28, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Translational head motion between different radiation therapy treatment sessions [8 weeks]

      Translation error (mm)

    2. Rotational head motion between different radiation therapy treatment sessions [8 weeks]

      Rotation error (°)

    3. Head deformation between different radiation therapy treatment sessions [8 weeks]

      Deformation error (mm)

    Secondary Outcome Measures

    1. Difference in structural similarity (SSIM) indexes between artificial and real X-rays [8 weeks]

      Image quality metric: Structural Similarity (SSIM) index.

    2. Difference in mean absolute error between artificial and real X-rays [8 weeks]

      Image quality metric: Mean Absolute Error.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Blacktown Hospital Blacktown New South Wales Australia 2148

    Sponsors and Collaborators

    • University of Sydney
    • Western Sydney Local Health District

    Investigators

    • Study Chair: Paul Keall, PhD, University of Sydney

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Sydney
    ClinicalTrials.gov Identifier:
    NCT05218824
    Other Study ID Numbers:
    • IX-2021-P0-CHIRP
    First Posted:
    Feb 1, 2022
    Last Update Posted:
    Feb 1, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 1, 2022