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

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.

Study Overview

• Status: Withdrawn
• Conditions: Radiotherapy
• Intervention / Treatment: Device: Conventional Bolus; Device: 3D Printed Bolus

Detailed Description

In radiation therapy, high-energy radiation beams treat tumors by damaging cancer cells. Treatment plans are designed with the goal of limiting exposure to adjacent healthy tissues. Commonly used radiation beams demonstrate the "skin-sparing effect" which means that the radiation dose builds up after the beam enters the skin and thus the maximum dose is reached at some depth beneath the skin. For many tumors, this spares the skin from unnecessary exposure while ensuring cancer cells beneath the skin receive the maximum dose. For cancers that lie at or just below the skin surface, however, it is desirable for the maximum dose be present at the skin surface. In such cases, a bolus (material with properties similar to tissue) is used to mimic tissue and is placed above the skin. Dose build up occurs within the bolus, thus allowing the maximum dose to be reached at the skin surface. Aside from the treatment of superficial tumors, boluses have recently been used for modulated electron radiation therapy (MERT). For MERT, the bolus thickness is varied so that the dose at a specific depth can be varied at different locations within the tissue. With this technique, the bolus is customized for a patient's specific anatomy and thus radiation exposure to healthy tissue is minimized.

Boluses are typically made from moldable materials such as paraffin wax or superflab. Conventional bolus preparation has its disadvantages; the patient is required to be present, it can be time intensive and it is dependent on the skill of the fabricator. Furthermore, the degree of conformity to the patient's skin is limited and, as a result, there can be significant air gaps between the bolus and the patient's skin. Such air gaps have been shown to create significant reduction in the surface dose.

The goal of the present study is to improve the current process of bolus preparation by creating customized boluses with 3D printing. Customized boluses can be designed in Varian eclipse software and then imported into 3D modeling software such as 3D Slicer. The 3D model can then be converted into STL (Stereolithography) format which can be interpreted by the 3D printer software. Several preliminary studies have reported success in creating such boluses. One study reported good fit without air gaps (Kim) in their 3D printed bolus. Additionally, several studies modeled tissue dose distributions for 3D printed boluses and found results were similar to those obtained for conventional boluses.

For the current study, the Investigators will enroll participants who require boluses as part of their treatment plan. Both a conventional and 3D bolus will be fabricated for each participant. Computer simulation of dose distributions will be used to compare dosimetric parameters. Additionally, air gaps for both boluses will be measured. For each participant, the bolus that results in a more optimized dose distribution will be used for the participant's actual treatment. Conducting the study will necessitate each enrolled participant to undergo an additional CT scan to simulate treatment with the 3D printed bolus.

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: All Participants; 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; Conventional bolus is mold made from Super stuff powder, superflab, or paraffin wax and made to fit the contours of the body.; Device: 3D Printed Bolus; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tulane University
• Investigators: Principal Investigator: Steven DiBase, MD, Tulane University

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: November 18, 2016
• First Submitted That Met QC Criteria: November 21, 2016
• First Posted (Estimate): November 22, 2016

Study Record Updates

• Last Update Posted (Actual): January 16, 2018
• Last Update Submitted That Met QC Criteria: January 11, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 16-933857

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Currently there is no plan to share IPD.