Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05218824




Registration number
NCT05218824
Ethics application status
Date submitted
8/12/2021
Date registered
1/02/2022
Date last updated
7/06/2024

Titles & IDs
Public title
Collection of Head Images During Radiotherapy
Scientific title
Collection of Head Images During Radiotherapy (CHIRP)
Secondary ID [1] 0 0
IX-2021-P0-CHIRP
Universal Trial Number (UTN)
Trial acronym
CHIRP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Neoplasms 0 0
Radiation Therapy Complication 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Translational head motion between different radiation therapy treatment sessions
Timepoint [1] 0 0
8 weeks
Primary outcome [2] 0 0
Rotational head motion between different radiation therapy treatment sessions
Timepoint [2] 0 0
8 weeks
Primary outcome [3] 0 0
Head deformation between different radiation therapy treatment sessions
Timepoint [3] 0 0
8 weeks
Secondary outcome [1] 0 0
Difference in structural similarity (SSIM) indexes between artificial and real X-rays
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
Difference in mean absolute error between artificial and real X-rays
Timepoint [2] 0 0
8 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 0 0
2148 - Blacktown

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Western Sydney Local Health District
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05218824
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Keall, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries