Collection of Head Images During Radiotherapy

Head and Neck Neoplasms Clinical Trial

— CHIRP  

Official title:

Collection of Head Images During Radiotherapy (CHIRP)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05218824
• Other study ID #: IX-2021-P0-CHIRP
• Status: Active, not recruiting
• Start date: February 14, 2022
• Est. completion date: February 28, 2024

Study information

• Verified date: January 2024
• Source: University of Sydney
• Contact: n/a
• Is FDA regulated: No
• 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: February 28, 2024
• Est. primary completion date: February 28, 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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Radiation Therapy Complication

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