Clinical trial · Interventional
3D Printed Rigid Bolus Versus Silicone Bolus for Treatment of Tumors Involving the Skin: A Comparative Study
3D Printed Rigid Bolus Versus Silicone Bolus: A Comparative Study
NCT04176900CI-TRIAL-00070101withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closed during Covid Pandemic, and no longer supported locally
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
| Skin Neoplasm Malignant | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ecoflex 030 | Other | — | UNRESOLVED |
| Ingeo Biopolymer (PLA) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alternating 3D boluses
- description
- Both rigid and flexible 3D printed boluses made for each patient. Each is used on alternate days during radiation therapy.
- interventionNames
- Other: Ingeo Biopolymer (PLA)
- Other: Ecoflex 030
Primary outcomes (2)
- measure
- Air Gap measurement
- timeFrame
- 6 weeks
- description
- Measurement of the gap between the bolus and the surface of the patient
- measure
- Planned versus expected radiation duse
- timeFrame
- 6 weeks
- description
- Comparison of the planned radiation dose at skin, and that measured during radiation therapy treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDCanters 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
- BACKGROUNDDipasquale 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
- BACKGROUNDKong 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
- BACKGROUNDRobar 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