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NCT04685460
3D Printed Bolus in Post-mastectomy Radiotherapy
NA trial testing customized 3D-printed bolus fabricated based on reconstruction of computed tomography (CT) images in Breast Neoplasms in 70 participants. Status unknown.
15 April 2021
Quick facts
| Lead sponsor | Jiangxi Provincial Cancer Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 1 March 2020 |
| Primary completion | 15 April 2021 |
| Estimated completion | 20 April 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- customized 3D-printed bolus fabricated based on reconstruction of computed tomography (CT) images
Conditions studied
- Breast Neoplasms — all drugs for Breast Neoplasms →
- Radiotherapy Side Effect — all drugs for Radiotherapy Side Effect →
Sponsor
Jiangxi Provincial Cancer Hospital
Who can join
Eligibility, any sex, with Breast Neoplasms or Radiotherapy Side Effect. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Recently, there is growing interest in the application of three-dimensional (3D) printed bolus to radiotherapy.At present, the researches on the application of 3D-printed bolus in breast cancer are mainly focused on air gap between skin and bolus or electron beam conformal therapy \[7,15\], there are no clinical experience with customized 3D-printed bolus for volumetric modulated arc therapy (VMAT) in daily practice has been published up to now. We aim to evaluate dosimetry and application of 3D-printed bolus for the post-mastectomy radiotherapy (PMRT) with Volumetric modulated arc therapy (VMAT). Seventy five patients with breast cancer receiving radiotherapy following post-mastectomy in our department were randomly selected in this study. The accuracy of fit of the 3D-Printed bolus to the chest wall was improved significantly relative to conventional bolus.This study demonstrates customized 3D-printed bolus in post-mastectomy radiation therapy improves fit of the bolus compared to conventional bolus. Furthermore, VMAT based on 3D-printed bolus significantly improves the chest wall target coverage and the conformity of plan, and reduces the dose of ipsilateral lung and heart, compared to conventional bolus.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A clinical trial to compare a 3D-printed bolus with a conventional bolus with the aim of reducing cardiopulmonary exposure in postmastectomy patients with volumetric modulated arc therapy.
Zhang Y, Huang Y, Ding S, Liang J, et al · · 2022 · cited 12× · PMID 34939343 · DOI 10.1002/cam4.4496
Verify or expand the search:
- PubMed search for NCT04685460
- Europe PMC full search
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04685460 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jiangxi Provincial Cancer Hospital
- Last refreshed: 19 April 2021
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