Collection of Head Images During Radiotherapy

Active, not recruiting

• Conditions: Head and Neck Neoplasms; Radiation Therapy Complication

• Registration Number: NCT05218824
• Lead Sponsor: University of Sydney

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.

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 Timeline

• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-02-01
• Study Start: 2022-02-14
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-07
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 32

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rotational head motion between different radiation therapy treatment sessions	8 weeks	Rotation error (degree)
Head deformation between different radiation therapy treatment sessions	8 weeks	Deformation error (mm)
Translational head motion between different radiation therapy treatment sessions	8 weeks	Translation error (mm)

Secondary Outcome Measures

Name	Time	Method
Difference in mean absolute error between artificial and real X-rays	8 weeks	Image quality metric: Mean Absolute Error.
Difference in structural similarity (SSIM) indexes between artificial and real X-rays	8 weeks	Image quality metric: Structural Similarity (SSIM) index.

Trial Locations

Locations (1)

Blacktown Hospital; 🇦🇺 Blacktown, New South Wales, Australia