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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05218824
Other study ID # IX-2021-P0-CHIRP
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 14, 2022
Est. completion date December 31, 2024

Study information

Verified date June 2024
Source University of Sydney
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 32
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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: - 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


Locations

Country Name City State
Australia Blacktown Hospital Blacktown New South Wales

Sponsors (2)

Lead Sponsor Collaborator
University of Sydney Western Sydney Local Health District

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Translational head motion between different radiation therapy treatment sessions Translation error (mm) 8 weeks
Primary Rotational head motion between different radiation therapy treatment sessions Rotation error (degree) 8 weeks
Primary Head deformation between different radiation therapy treatment sessions Deformation error (mm) 8 weeks
Secondary Difference in structural similarity (SSIM) indexes between artificial and real X-rays Image quality metric: Structural Similarity (SSIM) index. 8 weeks
Secondary Difference in mean absolute error between artificial and real X-rays Image quality metric: Mean Absolute Error. 8 weeks
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