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

NCT04176900 | Withdrawn DMC

• 1 other identifier: 15441
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Skin Neoplasm Malignant; Skin Cancer

Keywords

Radiation Therapy; Radiation Dosimetry; Patient Reported Outcomes; 3D-printed bolus

Outcome Measures

Primary Outcomes (2)

• Air Gap measurement

  Measurement of the gap between the bolus and the surface of the patient

  6 weeks

• Planned versus expected radiation duse

  Comparison of the planned radiation dose at skin, and that measured during radiation therapy treatment

  6 weeks

Secondary Outcomes (6)

• Ease of Use

  6 weeks

• Radiation Therapist ease of use

  6 weeks

• Challenges with Bolus Use

  6 weeks

• Patient Reported Outcomes

  6 weeks

• Fabrication time

  2 weeks

Study Arms (1)

Alternating 3D boluses

EXPERIMENTAL

Both rigid and flexible 3D printed boluses made for each patient. Each is used on alternate days during radiation therapy.

Other: Ingeo Biopolymer (PLA); Other: Ecoflex 030

Interventions

Ingeo Biopolymer (PLA) OTHER

Biopolymer used for 3D-printing of rigid bolus

Also known as: 3D-Fuel PLA

Alternating 3D boluses

Ecoflex 030 OTHER

Polymer used for the 3D-printed flexible bolus

Also known as: 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

Alternating 3D boluses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Cancer Centre: lead

Related Publications (4)

• Canters RA, Lips IM, Wendling M, Kusters M, van Zeeland M, Gerritsen RM, Poortmans P, Verhoef CG. Clinical implementation of 3D printing in the construction of patient specific bolus for electron beam radiotherapy for non-melanoma skin cancer. Radiother Oncol. 2016 Oct;121(1):148-153. doi: 10.1016/j.radonc.2016.07.011. Epub 2016 Jul 27.

  PMID: 27475278 BACKGROUND

• Dipasquale G, Poirier A, Sprunger Y, Uiterwijk JWE, Miralbell R. Improving 3D-printing of megavoltage X-rays radiotherapy bolus with surface-scanner. Radiat Oncol. 2018 Oct 19;13(1):203. doi: 10.1186/s13014-018-1148-1.

  PMID: 30340612 BACKGROUND

• Kong Y, Yan T, Sun Y, Qian J, Zhou G, Cai S, Tian Y. A dosimetric study on the use of 3D-printed customized boluses in photon therapy: A hydrogel and silica gel study. J Appl Clin Med Phys. 2019 Jan;20(1):348-355. doi: 10.1002/acm2.12489. Epub 2018 Nov 7.

  PMID: 30402935 BACKGROUND

• Robar JL, Moran K, Allan J, Clancey J, Joseph T, Chytyk-Praznik K, MacDonald RL, Lincoln J, Sadeghi P, Rutledge R. Intrapatient study comparing 3D printed bolus versus standard vinyl gel sheet bolus for postmastectomy chest wall radiation therapy. Pract Radiat Oncol. 2018 Jul-Aug;8(4):221-229. doi: 10.1016/j.prro.2017.12.008. Epub 2017 Dec 24.

  PMID: 29452866 BACKGROUND

Related Links

• National Comprehensive Cancer Network (NCCN). Squamous Cell Skin Cancer. NCCN Clinical Practice Guidelines in Oncology. Version 1.2020.

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lara R Best, MD, FRCPC

  Nova Scotia Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Model Details: All patients will have both the rigid and flexible 3D printed boluses made. Each will be used on alternate days during radiation therapy treatments.

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 25, 2019
• Study Start: March 1, 2020
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share