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A study on Clinical Target Volume of 3D printed template-assisted CT-guided radioactive iodine 125 seed implantation for recurrent head and neck squamous cell carcinoma

A study on Clinical Target Volume of 3D printed template-assisted CT-guided radioactive iodine 125 seed implantation for recurrent head and neck squamous cell carcinoma(2020-BYSY-HNCTV)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042908
Enrollment
Unknown
Registered
2021-01-31
Start date
2021-02-11
Completion date
Unknown
Last updated
2021-05-17

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

Conditions

Recurrent head and neck squamous cell carcinoma

Interventions

Arm 1:radioactive iodine 125 seed implantation
Arm 2:radioactive iodine 125 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. Patients with lesion diameter = 70; 8. Subjects with 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 9. Subjects with good liver function: serum total bilirubin concentration = 50%; 12. Patients whose expected survival time is 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 18 s, prothrombin activity < 40%, and anticoagulant therapy and / or antiplatelet aggregation 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