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A study on the prescription dose of 3D printed template-assisted CT-guided radioactive iodine 125 seed implantation for recurrent retroperitoneal lymphatic metastasis after external radiotherapy

A study on the prescription dose of 3D printed template-assisted CT-guided radioactive iodine 125 seed implantation for recurrent retroperitoneal lymphatic metastasis after external radiotherapy (BYSY-2020-RRLNM)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000039707
Enrollment
Unknown
Registered
2020-11-06
Start date
2020-11-09
Completion date
Unknown
Last updated
2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent retroperitoneal lymphatic metastasis

Interventions

Arm1:High-dose (145±15Gy) radioactive 125I seed implantation
Arm2:Low-dose (115±15Gy) radioactive 125I seed implantation

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients confirmed by pathology; 2. In patients with imaging evaluable lesions, the diameter was less than or equal to 7 cm; 3. The patients who have received external radiotherapy in the past can not tolerate or refuse to receive external radiotherapy again; 4. Patients who can tolerate anesthesia; 5. Patients who can tolerate puncture; 6. Patients aged 18-80 years old; 7. Patients with KPS >= 70; 8. Sufficient blood reserve: white blood cell count >= 3 x 10^9 / ml; granulocyte count >= 1.5 x 10^9 / ml; hemoglobin >= 90g / L; platelet > 50 x 10^9 / L; blood pressure >= 1.5 x 10^9 / ml; 9. Subjects with good liver function: serum total bilirubin concentration = 50%; 12. Patients whose expected survival time was more than 3 months; 13. Patients who volunteered and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients without proper puncture path; 2. Patients whose preoperative plan design can not meet the requirements of clinical treatment; 3. Patients with severe bleeding tendency, such as platelet 18S, prothrombin activity < 40%, and anticoagulant therapy and / or antiplatelet coagulation drugs stopped for less than 1 week before particle implantation; 4. Patients with severe complications leading to clinical risk (such as severe hypertension, diabetes, etc.); 5. Patients with skin ulceration caused by tumor; 6. Patients with active infectious diseases, trauma, stroke and severe trauma; 7. Patients with mental disorders; 8. Pregnant or lactating women; 9. Patients allergic to iodine contrast agent; 10. Patients participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Local progression-free survival;

Secondary

MeasureTime frame
Dosimetry;Objective response rate;Disease control rate;Pain relief rate;Treatment-related toxicity;Overall survival;Quality of life;

Countries

China

Contacts

Public ContactWang Junjie

Peking University Third Hospital

junjiewang_edu@sina.com+86 13701076310

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026