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

Head and Neck Cancer Clinical Trial

Official title:

Feasibility Study: Acquisition of Three Dimensional Facial Geometry of Patients' Scheduled for Head and Neck Radiotherapy Treatment.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02930915
• Other study ID #: 82-03-16
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 10, 2016
• Last updated: October 10, 2016
• Start date: June 2016
• Est. completion date: September 2017

Study information

• Verified date: October 2016
• Source: University of East Anglia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• Have a Head-and-neck cancer

• Receiving radiotherapy treatments (CT images)

Exclusion Criteria:

• Children (age less than 18)

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Device:
• Hand-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.

Locations

Country	Name	City	State
United Kingdom	Norfolk and Norwich Univeristy Hospital NHS foundation Trust	Norwich	Norfolk
United Kingdom	School of Computing Sciences, University of East Anglia	Norwich	Norfolk

Sponsors (2)

Lead Sponsor	Collaborator
University of East Anglia	Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 minutes	No