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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
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Scientific title
Collection of Head Images During Radiotherapy (CHIRP)
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Secondary ID [1]
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IX-2021-P0-CHIRP
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Universal Trial Number (UTN)
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Trial acronym
CHIRP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Head and Neck Neoplasms
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Radiation Therapy Complication
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Condition category
Condition code
Cancer
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Head and neck
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Translational head motion between different radiation therapy treatment sessions
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Assessment method [1]
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Translation error (mm)
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Timepoint [1]
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8 weeks
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Primary outcome [2]
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Rotational head motion between different radiation therapy treatment sessions
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Assessment method [2]
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Rotation error (degree)
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Timepoint [2]
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8 weeks
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Primary outcome [3]
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Head deformation between different radiation therapy treatment sessions
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Assessment method [3]
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Deformation error (mm)
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Timepoint [3]
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8 weeks
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Secondary outcome [1]
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Difference in structural similarity (SSIM) indexes between artificial and real X-rays
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Assessment method [1]
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Image quality metric: Structural Similarity (SSIM) index.
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Timepoint [1]
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8 weeks
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Secondary outcome [2]
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Difference in mean absolute error between artificial and real X-rays
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Assessment method [2]
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Image quality metric: Mean Absolute Error.
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Timepoint [2]
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8 weeks
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/02/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
32
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Blacktown Hospital - Blacktown
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Western Sydney Local Health District
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05218824
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Paul Keall, PhD
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Address
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University of Sydney
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05218824
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