NCT02930915

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

October 10, 2016

Last Update Submit

October 10, 2016

Conditions

Keywords

Head and Neck CancerRadiotherapy

Outcome Measures

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.

    15 minutes

Interventions

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.

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Children (age less than 18)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

School of Computing Sciences, University of East Anglia

Norwich, Norfolk, NR4 7TJ, United Kingdom

Location

Norfolk and Norwich Univeristy Hospital NHS foundation Trust

Norwich, Norfolk, NR47UY, United Kingdom

Location

Related 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.

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Mark Fisher, PhD

    University of East Anglia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2016

First Posted

October 12, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2017

Study Completion

September 1, 2017

Last Updated

October 12, 2016

Record last verified: 2016-10

Locations