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

October 10, 2016 updated by: University of East Anglia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Children (age less than 18)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of East Anglia

Collaborators

Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

Investigators

  • Principal Investigator: Mark Fisher, PhD, University of East Anglia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

October 10, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (Estimate)

October 12, 2016

Study Record Updates

Last Update Posted (Estimate)

October 12, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 82-03-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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