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3D Printed Rigid Bolus Versus Silicone Bolus for Treatment of Tumors Involving the Skin: A Comparative Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04176900
Recruitment Status : Unknown
Verified February 2020 by Lara Best, MD, FRCPC, MMEd, Nova Scotia Cancer Centre.
Recruitment status was:  Not yet recruiting
First Posted : November 25, 2019
Last Update Posted : February 26, 2020
Information provided by (Responsible Party):
Lara Best, MD, FRCPC, MMEd, Nova Scotia Cancer Centre

Brief Summary:
This study compares two types of 3D-printed skin bolus (rigid and flexible) used to optimize the treatment of tumors/cancers involving the skin. Each patient will have both types of bolus made, with each will be used on alternating days. The goal is to determine if one type of bolus provides a better fit and thus radiotherapy plan, the ease of use of each type of bolus, and patient reported feedback.

Condition or disease Intervention/treatment Phase
Skin Neoplasm Malignant Skin Cancer Other: Ingeo Biopolymer (PLA) Other: Ecoflex 030 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All patients will have both the rigid and flexible 3D printed boluses made. Each will be used on alternate days during radiation therapy treatments.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 3D Printed Rigid Bolus Versus Silicone Bolus: A Comparative Study
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 30, 2022

Arm Intervention/treatment
Experimental: Alternating 3D boluses
Both rigid and flexible 3D printed boluses made for each patient. Each is used on alternate days during radiation therapy.
Other: Ingeo Biopolymer (PLA)
Biopolymer used for 3D-printing of rigid bolus
Other Name: 3D-Fuel PLA

Other: Ecoflex 030
Polymer used for the 3D-printed flexible bolus
Other Names:
  • Body Double & Body Double SILK
  • Dragon Skin Series & F/X Pro
  • Encapso K
  • Equinox Series
  • EZ Brush Silicone
  • EZ-Spray Silicone Series
  • Mold Max Series
  • Mold Star Series
  • OOMOO Series
  • PoYo Putty 40
  • Psycho Paint
  • Rebound Series
  • Rubber Glass
  • Silicone 1515, 1603, 3030, 1708
  • Skin Tite
  • Smooth-Sil Series
  • Solaris
  • SomaFoama Series
  • SORTA-Clear Series

Primary Outcome Measures :
  1. Air Gap measurement [ Time Frame: 6 weeks ]
    Measurement of the gap between the bolus and the surface of the patient

  2. Planned versus expected radiation duse [ Time Frame: 6 weeks ]
    Comparison of the planned radiation dose at skin, and that measured during radiation therapy treatment

Secondary Outcome Measures :
  1. Ease of Use [ Time Frame: 6 weeks ]
    Time required to place bolus in proper location prior to each radiation therapy treatment

  2. Radiation Therapist ease of use [ Time Frame: 6 weeks ]
    Radiation therapists asked to rate ease of use for each type of bolus

  3. Challenges with Bolus Use [ Time Frame: 6 weeks ]
    Comparison of the number of times each bolus could not be adequately applied prior to radiation therapy treatment

  4. Patient Reported Outcomes [ Time Frame: 6 weeks ]
    Patients asked about comfort associated with each bolus, their preference between the two, and any other feedback on the boluses

  5. Fabrication time [ Time Frame: 2 weeks ]
    Comparison of average fabrication time for each type of bolus

  6. Successful fabrication [ Time Frame: 2 weeks ]
    Comparison of percentage of cases for which an acceptable bolus could be created for each type of bolus

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of a primary skin cancer or metastatic cancer with involvement of the skin or underlying soft tissues
  • Being treated with radiation therapy that requires the use of bolus to ensure adequate radiotherapy dose to the skin in the affected area
  • Planned for palliative or curative intent radiotherapy using megavoltage (MV) photons
  • Site of involvement has significant contour change, leading to anticipated challenges using conventional bolus material
  • Patient must be competent and able to complete informed consent
  • Age ≥ 18
  • Women of childbearing potential must be proven to not be pregnant or breast feeding

Exclusion Criteria:

  • Patient being treated with a radiotherapy technique that does not require bolus
  • Patient being treated with a radiotherapy technique other than MV photons (i.e. electrons, brachytherapy, kilovoltage (kV) photons)
  • Patient of childbearing potential who is pregnant, actively trying to become pregnant or breast feeding
  • Allergy to silicone or other components of either the 3D printed rigid or flexible bolus.
  • Size of the bolus required for treatment exceeds 25cm in maximum diameter

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04176900

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Contact: Lara R Best, MD, FRCPC +19024736185
Contact: Jim Clancey, RTT, CMD +19024736055

Sponsors and Collaborators
Nova Scotia Cancer Centre
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Principal Investigator: Lara R Best, MD, FRCPC Nova Scotia Cancer Centre
Additional Information:
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Responsible Party: Lara Best, MD, FRCPC, MMEd, Radiation Oncologist, Nova Scotia Cancer Centre Identifier: NCT04176900    
Other Study ID Numbers: 15441
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Lara Best, MD, FRCPC, MMEd, Nova Scotia Cancer Centre:
Radiation Therapy
Radiation Dosimetry
Patient Reported Outcomes
3D-printed bolus
Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Skin Diseases