Head and Neck CancerNCT02930915
Acquisition of 3D Facial Geometry of Patients' Scheduled for Radiotherapy Treatment
An observational study of Head and Neck Cancer, run by University of East Anglia at 2 sites in United Kingdom.
Trial summary
This study investigates the feasibility of using 3D-Printing to manufacture masks used to immobilize patients undergoing radiotherapy treatment for tumors affecting the head and neck. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Hand-held laser scanner
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jun 2016to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A cohort of patients who have a Head-and-neck cancer and receiving radiotherapy treatments in the Norfolk and Norwich University Hospital.
Who may be able to join
- Have a Head-and-neck cancer
- Receiving radiotherapy treatments (CT images)
Who cannot join
- Children (age less than 18)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
School of Computing Sciences, University of East Anglia
Norwich, Norfolk, NR4 7TJ
Norfolk and Norwich Univeristy Hospital NHS foundation Trust
Norwich, Norfolk, NR47UY
About this study
Official title: Feasibility Study: Acquisition of Three Dimensional Facial Geometry of Patients' Scheduled for Head and Neck Radiotherapy Treatment.
This study investigates the feasibility of using 3D-Printing to manufacture masks used to immobilize patients undergoing radiotherapy treatment for tumors affecting the head and neck.
Read the detailed description
The current types of masks that are used in radiotherapy treatment sessions for those patients who have head-and-neck cancer are 'made to measure' and the methods currently employed to make them are invasive and in some cases patients' have found this to be particularly unpleasant. Their experience motivates research into less invasive and potentially more accurate techniques for their manufacture.
To effectively develop an automatic manufacturing pipeline, and to assess the accuracy of the approach we need access to CT data from a cohort of patients for which we also have an accurate (ground truth) 3D facial model. Such a model can be acquired in a few minutes using a hand-held laser scanner.
- Conditions
- Head and Neck Cancer
- Being tested
- Hand-held laser scanner
- Keywords
- Head and Neck Cancer, Radiotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand-held laser scannerDevice
The laser scanning is non-intrusive and the scan can be completed in approximately 15 minutes. The scanning process involves the patient sitting in a chair while a researcher performs the scan. As a precautionary measure we require the patient to wear an eye mask as although the scanner is CE marked and completely safe . The process can be completed in stages (e.g. 3 x 5 minutes) with a break of 2-3 minutes between each session. The laser scanner will then be moved around the patient to obtain a set of 3D points forming the surface of the patient's head. We believe the laser scanning to be the most accurate way to acquire the surface of the patient's face / head and we wish to compare the models we obtain with surfaces rendered from the patient's CT data set.
What is being measured
The primary outcome is the main question the study is designed to answer.
3D facial geometry of patient's head
The resultant 3D facial geometry of patient's head will be used to construct a 3D digital model which will be used to evaluate the accuracy of the model generated by CT images. In other words, the outcome will be used as a ground-truth for the CT-derived model.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
- Responsible party
- Sponsor
- Investigators
- Mark Fisher, PhD, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930915
- Sponsor's protocol ID
- 82-03-16
- Status last verified
- Oct 2016
- First submitted
- 10 Oct 2016
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Fisher, Mark, Christopher Applegate, Mohammad Ryalat, Stephen Laycock, Mark Hulse, Daniel Emmens, and Duncan Bell. Evaluation of 3-d printed immobilisation shells for head and neck IMRT. Open Journal of Radiology 4, no. 04 (2014): 322.
Laycock, S. D., M. Hulse, C. D. Scrase, M. D. Tam, S. Isherwood, D. B. Mortimore, D. Emmens, J. Patman, S. C. Short, and G. D. Bell. Towards the production of radiotherapy treatment shells on 3D printers using data derived from DICOM CT and MRI: preclinical feasibility studies. Journal of Radiotherapy in Practice 14, no. 01 (2015): 92-98.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study: Acquisition of Three Dimensional Facial Geometry of Patients' Scheduled for Head and Neck Radiotherapy Treatment.
- ClinicalTrials.gov ID
- NCT02930915
- Acronym / sponsor ID
- 82-03-16
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, Radiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 12 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the feasibility of using 3D-Printing to manufacture masks used to immobilize patients undergoing radiotherapy treatment for tumors affecting the head and neck.
Detailed description
The current types of masks that are used in radiotherapy treatment sessions for those patients who have head-and-neck cancer are 'made to measure' and the methods currently employed to make them are invasive and in some cases patients' have found this to be particularly unpleasant. Their experience motivates research into less invasive and potentially more accurate techniques for their manufacture.
To effectively develop an automatic manufacturing pipeline, and to assess the accuracy of the approach we need access to CT data from a cohort of patients for which we also have an accurate (ground truth) 3D facial model. Such a model can be acquired in a few minutes using a hand-held laser scanner.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of patients who have a Head-and-neck cancer and receiving radiotherapy treatments in the Norfolk and Norwich University Hospital.
Key inclusion criteria (2 listed)
- Have a Head-and-neck cancer
- Receiving radiotherapy treatments (CT images)
Key exclusion criteria (1 listed)
- Children (age less than 18)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand-held laser scannerThe laser scanning is non-intrusive and the scan can be completed in approximately 15 minutes. The scanning process involves the patient sitting in a chair while a researcher performs the scan. As a precautionary measure we require the patient to wear an eye mask as although the scanner is CE marked and completely safe . The process can be completed in stages (e.g. 3 x 5 minutes) with a break of 2-3 minutes between each session. The laser scanner will then be moved around the patient to obtain a set of 3D points forming the surface of the patient's head. We believe the laser scanning to be the most accurate way to acquire the surface of the patient's face / head and we wish to compare the models we obtain with surfaces rendered from the patient's CT data set. | Device | – |
Primary outcome
3D facial geometry of patient's head
Time frame: 15 minutes
The resultant 3D facial geometry of patient's head will be used to construct a 3D digital model which will be used to evaluate the accuracy of the model generated by CT images. In other words, the outcome will be used as a ground-truth for the CT-derived model.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- BackgroundFisher, Mark, Christopher Applegate, Mohammad Ryalat, Stephen Laycock, Mark Hulse, Daniel Emmens, and Duncan Bell. Evaluation of 3-d printed immobilisation shells for head and neck IMRT. Open Journal of Radiology 4, no. 04 (2014): 322.
- BackgroundLaycock, S. D., M. Hulse, C. D. Scrase, M. D. Tam, S. Isherwood, D. B. Mortimore, D. Emmens, J. Patman, S. C. Short, and G. D. Bell. Towards the production of radiotherapy treatment shells on 3D printers using data derived from DICOM CT and MRI: preclinical feasibility studies. Journal of Radiotherapy in Practice 14, no. 01 (2015): 92-98.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Fisher, PhD principal investigator
University of East Anglia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by University of East Anglia at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D facial geometry of patient's head (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02930915, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2016; AzTrials last refreshed its copy on 8 Nov 2026.