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CompletedNCT05218824CHIRPUpdated May 19, 2026

Collection of Head Images During Radiotherapy

An observational study in Head and Neck Neoplasms and Radiation Therapy Complication, sponsored by University of Sydney. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.

Sponsored by University of Sydney · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
32
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Head and Neck Neoplasms
  • Radiation Therapy Complication
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's enrollment of 32 is below the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

University of Sydney is the lead sponsor of 91 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
32 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Translational head motion between different radiation therapy treatment sessions

    Translation error (mm)

    Time frame: 8 weeks

  2. Rotational head motion between different radiation therapy treatment sessions

    Rotation error (degree)

    Time frame: 8 weeks

  3. Head deformation between different radiation therapy treatment sessions

    Deformation error (mm)

    Time frame: 8 weeks

Secondary outcomes

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

    Image quality metric: Structural Similarity (SSIM) index.

    Time frame: 8 weeks

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

    Image quality metric: Mean Absolute Error.

    Time frame: 8 weeks

07

Study locations

1 site
  • Blacktown Hospital
    Blacktown, New South Wales 2148, Australia
08

References and documents

Individual participant data

Plan to share: Yes — After study completion and publication, de-identified (non-coded, non-reidentifiable) data and medical images may be shared publicly with researchers for further scientific research. This will ensure that the potential of the data acquired in this trial is maximised. This is in accordance with the NHMRC guidelines on the publication and dissemination of research, and in line with archives, e.g. the TCIA (https://www.cancerimagingarchive.net/).

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05218824
Lead sponsor
University of Sydney
Collaborators
Western Sydney Local Health District
Responsible party
Sponsor
First posted
Feb 1, 2022
Start date
Feb 14, 2022
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
May 19, 2026

Study contacts

Paul Keall, PhD
study chair · University of Sydney

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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