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NCT05351268
3DPCT Combined With CT Guided RISI in the Treatment of Thoracic Malignant Tumors
NA trial testing Radioactive seed brachytherapy in Radioactive Iodine-125 Brachytherapy in 30 participants. Currently enrolling.
30 April 2024
Quick facts
| Lead sponsor | Peking University Third Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 May 2022 |
| Primary completion | 30 April 2024 |
| Estimated completion | 30 April 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Radioactive seed brachytherapy
Conditions studied
- Radioactive Iodine-125 Brachytherapy — all drugs for Radioactive Iodine-125 Brachytherapy →
- Thoracic Cancer — all drugs for Thoracic Cancer →
- 3D Printing Coplanar Template — all drugs for 3D Printing Coplanar Template →
- Nuclear Radiation Effects — all drugs for Nuclear Radiation Effects →
Sponsor
Peking University Third Hospital
Who can join
Adults 18 to 80, any sex, with Radioactive Iodine-125 Brachytherapy or Thoracic Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main technical difficulties in radioactive iodine-125 seed implantation (RISI) lie in the complexity of operation and the control of operation quality. The current data shows that under the combined guidance of 3D-printing template and CT, the accuracy of RISI has been significantly improved, and the actual target dose could meet the design requirements of preoperative plan. At present, 3D printing templates (3DPT) are divided into non-coplanar templates (3DPNCT) and coplanar templates (3DPCT). In clinical practice, due to the complex technical requirements, high production cost and long printing time of 3DPNCT, a considerable number of patients can also complete the treatment with 3DPCT. Moreover, compared with 3DPNCT, 3DPCT has the advantages of accurate needle path control, fast needle path adjustment, convenient for intraoperative real-time optimization, without waiting for printing time, easy for doctors to master, lower cost than 3DPNCT, and easy to carry out at the grass-roots level. Therefore, this study intends to explore 3DPCT technology to further clarify: (1) the accuracy of 3DPCT assisted CT guided RISI in the treatment of thoracic malignant tumors; (2) the short-term efficacy and toxicity of 3DPCT assisted CT guided RISI in the treatment of thoracic malignant tumors.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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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 NCT05351268 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Peking University Third Hospital
- Last refreshed: 20 December 2023
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