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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05218824
Ethics application status
Date submitted
8/12/2021
Date registered
1/02/2022

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
Trial website
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

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05218824