ClinicalTrials.gg
Status unknownNCT02930915Updated Oct 12, 2016

Acquisition of 3D Facial Geometry of Patients' Scheduled for Radiotherapy Treatment

An observational study in Head and Neck Cancer, sponsored by University of East Anglia. Status unknown at 2 sites in United Kingdom. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2016-10-12.

Sponsored by University of East Anglia · Observational

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
12
Ages
18 Years to 69 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Head and Neck Cancer

Keywords

  • Head and Neck Cancer
  • Radiotherapy
03

In context

Head and Neck Neoplasms

2,402 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.

This study's planned enrollment of 12 is below the median of 100 across 453 observational studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

University of East Anglia is the lead sponsor of 79 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

A cohort of patients who have a Head-and-neck cancer and receiving radiotherapy treatments in the Norfolk and Norwich University Hospital.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Have a Head-and-neck cancer
  • Receiving radiotherapy treatments (CT images)

Exclusion criteria

Exclusion Criteria:

  • Children (age less than 18)
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
12 participants (estimated)
Patient registry
No

Interventions

  • DeviceHand-held laser scanner

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 15 minutes

07

Study locations

2 sites
  • School of Computing Sciences, University of East Anglia
    Norwich, Norfolk NR4 7TJ, United Kingdom
  • Norfolk and Norwich Univeristy Hospital NHS foundation Trust
    Norwich, Norfolk NR47UY, United Kingdom
08

References and documents

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.

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02930915
Lead sponsor
University of East Anglia
Collaborators
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Responsible party
Sponsor
First posted
Oct 12, 2016
Start date
Jun 2016
Primary completion
Jun 2017 (estimated)
Completion
Sep 2017 (estimated)
Last update
Oct 12, 2016

Study contacts

Mark Fisher, PhD
principal investigator · University of East Anglia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion