A Study Utilizing 3D Printing in Patients Undergoing External Beam Radiation Therapy

NCT02970474 | Withdrawn Phase 1

• 1 other identifier: 16-933857
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Some radiation therapy treatment plans require the use of boluses. Boluses are placed directly on the skin overlying the area to be treated. The radiation beam interacts with the bolus before entering the body and ensures that the correct radiation dose reaches your tumor. The purpose of this study is to determine whether the shortcomings of conventional bolus preparation can be overcome by using a 3D printer. CT scans of the body can be used to create 3D models for boluses. The 3D models can then be printed into plastic boluses using a 3D printer. Preliminary studies have shown that 3D printed boluses conform to body contours better and allow for more precise control over radiation dose. In this study, both a conventional and 3D printed bolus will be made. The Investigators will then simulate treatment with both boluses to determine which bolus will result in more optimal treatment for the participant. The superior bolus will be used in the participant's treatment.

Conditions

Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Optimal radiation dose

  Boluses are used in radiation therapy to assure the optimal dose of radiation is applied to the tumor. Conventional boluses may have air gaps between the mold and the participants skin, or deform over time and use, which may make the dose of radiation change and not be at the optimal dose for the tumor. Therefore a 3D printed bolus will be molded based on a participant's CT images to construct a bolus to deliver the optimal dose of radiation to the tumor. Both boluses will be tested through a computer simulation to asses which bolus, conventional or 3D printed, provides the optimal radiation dose.

  1 day

Study Arms (1)

All Participants

OTHER

All participants will undergo the same schedule. Each participant will be fitted with a conventional and a 3D printed bolus prior to receiving radiation therapy. Each bolus will be assessed for optimal dose distribution of the radiation to the tumor through computer stimulation. The bolus, either conventional or 3D printed, that is found to be superior will be used for the actual radiation therapy treatment.

Device: Conventional Bolus; Device: 3D Printed Bolus

Interventions

Conventional Bolus DEVICE

Conventional bolus is mold made from Super stuff powder, superflab, or paraffin wax and made to fit the contours of the body.

All Participants

3D Printed Bolus DEVICE

The 3D printed bolus is also made from Super stuff powder, superflab, or paraffin wax, however it uses CT scans to print a molded bolus from the images of the participant's body.

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Requires bolus and is schedule for radiation therapy

Sponsors & Collaborators

• Tulane University: lead

Study Sites (1)

Tulane University Cancer Center

New Orleans, Louisiana, 70112, United States

Location

Study Officials

• Steven DiBase, MD

  Tulane University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 22, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: January 16, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)