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RadiotherapyPhase 1/2NCT02970474

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

A Phase 1/2 study testing Conventional Bolus and 3D Printed Bolus in people with Radiotherapy, run by Tulane University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Radiotherapy
What is being tested?
Conventional Bolus and 3D Printed Bolus
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Aug 2016to Aug 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Tulane University Cancer Center

    New Orleans, Louisiana, 70112

Other trials in United States

About this study

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.

Read the 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.

Conditions
Radiotherapy
Being tested
Conventional Bolus, 3D Printed Bolus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional BolusDevice

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

  • 3D Printed BolusDevice

    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.

Study groups in NCT02970474
Study groupRoleWhat they receive
All ParticipantsOtherAll 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.
Receives: Device: Conventional Bolus; Device: 3D Printed Bolus

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionAug 2017
  4. Study completionAug 2017

Why it stopped: Lack of enrollment and loss of co-investigator.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02970474
Sponsor's protocol ID
16-933857
Status last verified
Jan 2018
First submitted
18 Nov 2016
Last updated
16 Jan 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Currently there is no plan to share IPD.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Conventional Bolus and 3D Printed Bolus in people with Radiotherapy, run by Tulane University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Optimal radiation dose (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.

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