Skin Neoplasm MalignantNCT04176900
3D Printed Rigid Bolus Versus Silicone Bolus for Treatment of Tumors Involving the Skin: A Comparative Study
A study testing Ingeo Biopolymer (PLA) and Ecoflex 030 in people with Skin Neoplasm Malignant and Skin Cancer, run by Nova Scotia Cancer Centre.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Neoplasm Malignant, Skin Cancer
- What is being tested?
- Ingeo Biopolymer (PLA) and Ecoflex 030
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to 28 Sep 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 3D Printed Rigid Bolus Versus Silicone Bolus: A Comparative Study
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.
Read the detailed description
Need for Skin Bolus during Radiotherapy for Cancers that Involve the Skin Using standard megavoltage (MV) radiotherapy to treat tumors that involve the skin is technically challenging as without modification, the high-energy radiotherapy machines under-dose the superficial tissue. This is a problem, as this may lead to an inadequate radiation dose being delivered to the skin, thus compromising tumor control. To compensate for this, a flexible polymer material ("bolus") measuring 5-10mm in thickness is placed over the skin during radiotherapy.
There are many types of boluses used internationally from rubber to candle wax slabs. The bolus allows the radiation dose to build up so that a sufficient dose is deposited at the skin. Use of bolus for cancers involving the skin is considered the standard of care when using conventional MV radiotherapy.
Challenges of Using Conventional Bolus Many standard boluses are slightly flexible, but are not able to follow significant changes in the underlying contours. When a bolus is not able to follow an individual's unique 'peaks and valleys' in contour, it can lead to air gaps between the bolus and the skin. An air gap, which is easily seen during imaging, can also vary on a day-to-day basis due to slight changes in positioning of the bolus prior to radiotherapy treatment. The varying air gaps can affect how much radiation dose is getting to the skin, and can potentially lead to under-dosing of the cancer cells in the skin. Even small air gaps (i.e. 5mm in thickness), can cause a 5% error in dose, which exceeds the safe tolerance for treatment.
Areas where this can be a problem are where the patient's anatomy undergoes significant topographical changes in a small area. Examples of this include the ear, nose, top of head. Patients with metastatic cancer can also have large lymph nodes or masses that are growing towards the skin that can be difficult to accommodate with standard bolus materials.
3D-Printed Bolus One method to overcome challenging anatomy for cases that require skin bolus for radiotherapy is the use of 3D-printed bolus. This technology uses data acquired from a CT scan of the affected area. The patients contour can then be used to create an individualized bolus that matches the patient contour for the treatment field. This technology has been demonstrated to improve fit (less air gaps) and decreased radiotherapy treatment time. The bolus used in this study was rigid.
Trial design and Rationale Other than the chestwall study, the literature on 3D-printed bolus for radiotherapy has focused on the dosimetry and feasibility of using this technology. However, it is used in an ad hoc method in many centers, using various workflows. There are no studies examining which type of bolus provides the best radiotherapy plan, is the easiest to use at the radiation therapy machines or which is preferred by patients.
To fill this gap, this study will aim to answer a few questions. It will compare the use of rigid 3D-printed bolus (most commonly used and reported in the literature) versus a flexible silicone 3D-printed bolus. Both types of bolus will be used to treat patients with cancers involving the skin. This will allow comparison of radiotherapy plans for each patient between the two types of bolus where each subject is his/her own control. The study will also collect data about real-time set-up using each bolus and feedback from radiation therapists (deliver radiation treatments) about the ease of use of each. Lastly, patients will complete a short survey to provide feedback about comfort with use of each type of bolus and to determine if one type of bolus is favored over the other.
This data will be instrumental is determining the standard of care of the use of 3D-printed bolus as it will assess two types of bolus in three domains: ability to help generate an adequate radiotherapy plan, ease of use by the specialists that deliver the radiotherapy (radiation therapists) and patient reported feedback.
- Conditions
- Skin Neoplasm Malignant, Skin Cancer
- Being tested
- Ingeo Biopolymer (PLA), Ecoflex 030
- Keywords
- Radiation Therapy, Radiation Dosimetry, Patient Reported Outcomes, 3D-printed bolus
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingeo Biopolymer (PLA)Other
Also called 3D-Fuel PLA
Biopolymer used for 3D-printing of rigid bolus
Ecoflex 030Other
Also called Body Double & Body Double SILK, Dragon Skin Series & F/X Pro, Encapso K, Equinox Series
Polymer used for the 3D-printed flexible bolus
| Study group | Role | What they receive |
|---|---|---|
| Alternating 3D boluses | Experimental | Both rigid and flexible 3D printed boluses made for each patient. Each is used on alternate days during radiation therapy. Receives: Other: Ingeo Biopolymer (PLA); Other: Ecoflex 030 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Air Gap measurement
Measurement of the gap between the bolus and the surface of the patient
Measured: 6 weeks
Planned versus expected radiation duse
Comparison of the planned radiation dose at skin, and that measured during radiation therapy treatment
Measured: 6 weeks
Secondary outcomes (6)
Ease of Use
Time required to place bolus in proper location prior to each radiation therapy treatment
Measured: 6 weeks
Radiation Therapist ease of use
Radiation therapists asked to rate ease of use for each type of bolus
Measured: 6 weeks
Challenges with Bolus Use
Comparison of the number of times each bolus could not be adequately applied prior to radiation therapy treatment
Measured: 6 weeks
Patient Reported Outcomes
Patients asked about comfort associated with each bolus, their preference between the two, and any other feedback on the boluses
Measured: 6 weeks
Fabrication time
Comparison of average fabrication time for each type of bolus
Measured: 2 weeks
Successful fabrication
Comparison of percentage of cases for which an acceptable bolus could be created for each type of bolus
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study startMar 2020 (estimated)
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
Why it stopped: Closed during Covid Pandemic, and no longer supported locally
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Skin Neoplasm MalignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Cancer Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Best, MD, FRCPC, MMEd, Nova Scotia Cancer Centre
- Investigators
- Lara R Best, MD, FRCPC, Principal investigator, Nova Scotia Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176900
- Sponsor's protocol ID
- 15441
- Status last verified
- Sep 2023
- First submitted
- 22 Nov 2019
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27475278Dipasquale 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.
PubMed 30340612Kong 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.
PubMed 30402935Robar 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.
PubMed 29452866
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Printed Rigid Bolus Versus Silicone Bolus: A Comparative Study
- ClinicalTrials.gov ID
- NCT04176900
- Acronym / sponsor ID
- 15441
- Conditions
- Skin Neoplasm Malignant, Skin Cancer
- Keywords
- Radiation Therapy, Radiation Dosimetry, Patient Reported Outcomes, 3D-printed bolus
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Closed during Covid Pandemic, and no longer supported locally
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nova Scotia Cancer CentreUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Need for Skin Bolus during Radiotherapy for Cancers that Involve the Skin Using standard megavoltage (MV) radiotherapy to treat tumors that involve the skin is technically challenging as without modification, the high-energy radiotherapy machines under-dose the superficial tissue. This is a problem, as this may lead to an inadequate radiation dose being delivered to the skin, thus compromising tumor control. To compensate for this, a flexible polymer material ("bolus") measuring 5-10mm in thickness is placed over the skin during radiotherapy.
There are many types of boluses used internationally from rubber to candle wax slabs. The bolus allows the radiation dose to build up so that a sufficient dose is deposited at the skin. Use of bolus for cancers involving the skin is considered the standard of care when using conventional MV radiotherapy.
Challenges of Using Conventional Bolus Many standard boluses are slightly flexible, but are not able to follow significant changes in the underlying contours. When a bolus is not able to follow an individual's unique 'peaks and valleys' in contour, it can lead to air gaps between the bolus and the skin. An air gap, which is easily seen during imaging, can also vary on a day-to-day basis due to slight changes in positioning of the bolus prior to radiotherapy treatment. The varying air gaps can affect how much radiation dose is getting to the skin, and can potentially lead to under-dosing of the cancer cells in the skin. Even small air gaps (i.e. 5mm in thickness), can cause a 5% error in dose, which exceeds the safe tolerance for treatment.
Areas where this can be a problem are where the patient's anatomy undergoes significant topographical changes in a small area. Examples of this include the ear, nose, top of head. Patients with metastatic cancer can also have large lymph nodes or masses that are growing towards the skin that can be difficult to accommodate with standard bolus materials.
3D-Printed Bolus One method to overcome challenging anatomy for cases that require skin bolus for radiotherapy is the use of 3D-printed bolus. This technology uses data acquired from a CT scan of the affected area. The patients contour can then be used to create an individualized bolus that matches the patient contour for the treatment field. This technology has been demonstrated to improve fit (less air gaps) and decreased radiotherapy treatment time. The bolus used in this study was rigid.
Trial design and Rationale Other than the chestwall study, the literature on 3D-printed bolus for radiotherapy has focused on the dosimetry and feasibility of using this technology. However, it is used in an ad hoc method in many centers, using various workflows. There are no studies examining which type of bolus provides the best radiotherapy plan, is the easiest to use at the radiation therapy machines or which is preferred by patients.
To fill this gap, this study will aim to answer a few questions. It will compare the use of rigid 3D-printed bolus (most commonly used and reported in the literature) versus a flexible silicone 3D-printed bolus. Both types of bolus will be used to treat patients with cancers involving the skin. This will allow comparison of radiotherapy plans for each patient between the two types of bolus where each subject is his/her own control. The study will also collect data about real-time set-up using each bolus and feedback from radiation therapists (deliver radiation treatments) about the ease of use of each. Lastly, patients will complete a short survey to provide feedback about comfort with use of each type of bolus and to determine if one type of bolus is favored over the other.
This data will be instrumental is determining the standard of care of the use of 3D-printed bolus as it will assess two types of bolus in three domains: ability to help generate an adequate radiotherapy plan, ease of use by the specialists that deliver the radiotherapy (radiation therapists) and patient reported feedback.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Alternating 3D boluses | Experimental | Other: Ingeo Biopolymer (PLA), Other: Ecoflex 030Both rigid and flexible 3D printed boluses made for each patient. Each is used on alternate days during radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ingeo Biopolymer (PLA)Also: 3D-Fuel PLABiopolymer used for 3D-printing of rigid bolus | Other | Alternating 3D boluses |
| Ecoflex 030Also: Body Double & Body Double SILK, Dragon Skin Series & F/X Pro, Encapso K, Equinox SeriesPolymer used for the 3D-printed flexible bolus | Other | Alternating 3D boluses |
Primary outcome
Air Gap measurement
Time frame: 6 weeks
Measurement of the gap between the bolus and the surface of the patient
Planned versus expected radiation duse
Time frame: 6 weeks
Comparison of the planned radiation dose at skin, and that measured during radiation therapy treatment
6 secondary outcomes
Ease of Use
Time frame: 6 weeks
Radiation Therapist ease of use
Time frame: 6 weeks
Challenges with Bolus Use
Time frame: 6 weeks
Patient Reported Outcomes
Time frame: 6 weeks
Fabrication time
Time frame: 2 weeks
Successful fabrication
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Background: PubMed 27475278Canters 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.
- Background: PubMed 30340612Dipasquale 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.
- Background: PubMed 30402935Kong 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.
- Background: PubMed 29452866Robar 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.
- Government of Canada. Non Melanoma Skin Cancer. 2014.Link provided by the sponsor.
- National Comprehensive Cancer Network (NCCN). Squamous Cell Skin Cancer. NCCN Clinical Practice Guidelines in Oncology. Version 1.2020.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lara R Best, MD, FRCPC principal investigator
Nova Scotia Cancer Centre
Questions about this trial
What is this clinical trial studying?
A study testing Ingeo Biopolymer (PLA) and Ecoflex 030 in people with Skin Neoplasm Malignant and Skin Cancer, run by Nova Scotia Cancer Centre.
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 7 inclusion and 5 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 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Air Gap measurement (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04176900, which also lists 4 linked publications.
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 2 Oct 2023.