Head and Neck NeoplasmsCHIRPNCT05218824
Collection of Head Images During Radiotherapy
An observational study of Head and Neck Neoplasms and Radiation Therapy Complication, run by University of Sydney at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Radiation Therapy Complication
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Feb 2022to 31 Dec 2024
- Phase
- Observational
- 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
Study population: Participants undergoing radiation therapy at Blacktown Hospital for head and neck cancer using a thermoplastic immobilisation mask
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collection of Head Images During Radiotherapy (CHIRP)
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.
- Medical subject headings
- Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Translational head motion between different radiation therapy treatment sessions
Translation error (mm)
Measured: 8 weeks
Rotational head motion between different radiation therapy treatment sessions
Rotation error (degree)
Measured: 8 weeks
Head deformation between different radiation therapy treatment sessions
Deformation error (mm)
Measured: 8 weeks
Secondary outcomes (2)
Difference in structural similarity (SSIM) indexes between artificial and real X-rays
Image quality metric: Structural Similarity (SSIM) index.
Measured: 8 weeks
Difference in mean absolute error between artificial and real X-rays
Image quality metric: Mean Absolute Error.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start14 Feb 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Western Sydney Local Health District
- Responsible party
- Sponsor
- Investigators
- Paul Keall, PhD, Study chair, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218824
- Sponsor's protocol ID
- IX-2021-P0-CHIRP
- Acronym
- CHIRP
- Status last verified
- May 2026
- First submitted
- 8 Dec 2021
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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/).
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Head Images During Radiotherapy (CHIRP)
- ClinicalTrials.gov ID
- NCT05218824
- Acronym / sponsor ID
- CHIRP / IX-2021-P0-CHIRP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- Western Sydney Local Health District
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 1 Feb 2022 (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.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants undergoing radiation therapy at Blacktown Hospital for head and neck cancer using a thermoplastic immobilisation mask
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Translational head motion between different radiation therapy treatment sessions
Time frame: 8 weeks
Translation error (mm)
Rotational head motion between different radiation therapy treatment sessions
Time frame: 8 weeks
Rotation error (degree)
Head deformation between different radiation therapy treatment sessions
Time frame: 8 weeks
Deformation error (mm)
2 secondary outcomes
Difference in structural similarity (SSIM) indexes between artificial and real X-rays
Time frame: 8 weeks
Difference in mean absolute error between artificial and real X-rays
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: 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/).
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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.
Paul Keall, PhD study chair
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Neoplasms and Radiation Therapy Complication, run by University of Sydney at 1 site in Australia.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 19 May 2026. 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 Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Translational head motion between different radiation therapy treatment sessions (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 19 May 2026.