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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04266223




Registration number
NCT04266223
Ethics application status
Date submitted
9/12/2019
Date registered
12/02/2020
Date last updated
6/05/2020

Titles & IDs
Public title
Surface Monitoring Technology to Remove The Mask - Stage 1
Scientific title
Surface Monitoring Technology to Remove The Mask - Stage 1
Secondary ID [1] 0 0
U1111-1248-2457
Secondary ID [2] 0 0
SMART1
Universal Trial Number (UTN)
Trial acronym
SMART1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 0 0
Radiation Therapy Complication 0 0
Anxiety 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Mask-free surface monitoring

Experimental: Mask-free surface monitoring - Lay in treatment position for 20 minutes with surface monitoring technology activated


Treatment: Devices: Mask-free surface monitoring
Mask-free headrest and couch for patient positioning for radiation therapy combined with a surface monitoring system

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Continuous acquisition of position and motion data of anatomical structures by the surface monitoring system - Technical feasibility of surface-monitoring system in =90% of consumers - operates continuously throughout the session and provides information on the position and motion of the cranium, mandible and shoulders without obvious erroneous results or faults
Timepoint [1] 0 0
20 minutes
Primary outcome [2] 0 0
Patient acceptance of the surface monitoring system - Patients complete the session AND give a mean score of 4 or more for both comfort and acceptability on a Likert scale of 1-7, where 1 = 'Very Strongly Disagree' and 7 = 'Very Strongly Agree'
Timepoint [2] 0 0
10 minutes
Secondary outcome [1] 0 0
Patient experience - Qualitative semi-structured interview of patient experience of interacting with the surface monitoring system and how that compared with the experience of the immobilisation mask during their radiation therapy treatment.
Timepoint [1] 0 0
45 minutes
Secondary outcome [2] 0 0
Radiation therapists' experience - Questionnaire of radiation therapist's experience scored according to a Likert scale of 1-5 where 1 = 'Strongly Disagree' and 5 = 'Strongly Agree'
Timepoint [2] 0 0
5 minutes
Secondary outcome [3] 0 0
Absolute Residual Motion of cranial and upper torso anatomy - Distance and direction of, and correlation between, motion of the cranial and upper torso anatomy relative to the fixed isocentre
Timepoint [3] 0 0
20 minutes
Secondary outcome [4] 0 0
Relative Residual Motion of cranial and upper torso anatomy - Distance and direction of, and correlation between, motion of the cranial and upper torso anatomy relative to first image taken
Timepoint [4] 0 0
20 minutes
Secondary outcome [5] 0 0
Change in number of detectable anatomical landmarks after patient residual motion - Change in number of detection of points in the point cloud in response to residual motion of anatomical landmarks over 20 minutes of continuous data acquisition
Timepoint [5] 0 0
20 minutes
Secondary outcome [6] 0 0
Photograph record of physical characteristics of face and hair that may affect detection of anatomical landmarks by the surface monitoring system - A photograph taken by the system camera showing physical characteristics of face and hair (e.g. shape, tone, location, size)
Timepoint [6] 0 0
5 seconds

Eligibility
Key inclusion criteria
- Previous diagnosis of head and neck cancer, any stage

- = 18 years of age

- ECOG Performance Status 0-2

- Previously treated with radiation therapy for head and neck cancer with a mask within
the previous 36 months

- Any prior therapy allowed

- Willing and able to comply with all study requirements

- Must be able to read and complete questionnaires in English
Minimum age
18 Years
Maximum age
No limit
Gender
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 of the study
Device Feasibility
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 0 0
2049 - 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
A pilot-stage device feasibility study investigating a mask-free motion-monitoring patient
immobilisation system for use during radiation therapy treatment of head and neck cancer
(HNC). This mask-free system combines a head rest to help the patient remain still with a
surface guidance detection system that uses sensors to detect patient movement.

Patients previously treated for head and neck cancer with radiation therapy that involved
using a mask will be asked to lie on the treatment couch for the normal treatment fraction
time while the surface monitoring system is activated. We will then assess:

i) The level of acceptance by previously treated HNC patients, and ii) The ability of the
surface guidance detecting equipment to monitor movement of the patients
Trial website
https://clinicaltrials.gov/show/NCT04266223
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Purmina Sundaresan, Dr
Address 0 0
Western Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Paul Keall, Prof
Address 0 0
Country 0 0
Phone 0 0
+61 2 8627 1133
Fax 0 0
Email 0 0
paul.keall@sydney.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04266223