A multi-center randomised controlled trial of iodine-125 seeds implantation guided by three-dimensional printing templete for the treatment of pelvic metastases

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IIR-16010106

Enrollment

Unknown

Registered

2016-12-08

Start date

2016-09-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

pelvic metastases

Interventions

experimental group:iodine-125 seeds implantation guided by three-dimensional printing templete

control group:iodine-125 seeds implantation guided by CT

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-80 years; 2. primary lesions confirmed by organization/cytological biopsy for malignant tumor, single pelvic metastatic lesion; 3. metastatic lesion 3 to 7cm diameter; 4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-3; 5. expected lifetime=3 months; 6. unable to accept surgical treatment; 7. willingness and to be able to complete the study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. history of radiation therapy for abdominal and pelvic; 2. pelvic metastatic lesions were multiple and diffuse distribution; 3. ECOG 4; 4. hemoglobin20s, activated partial thromboplastin time>55s, thrombin time>21sprothrombin time-international normalized ratio>2.5; 6. hypohepatia and renal inadequacy: Child-Pugh classification grade C, glomerular filtration rate451umol/Lendogenous creatinine clearance rate<19ml/min.

Design outcomes

Primary

Measure	Time frame
quality validation rate;	—

Secondary

Measure	Time frame
technical success rate;time of operation;local control rate;	—

Countries

China

Contacts

Public ContactJin-He Guo

Zhong-Da Hospital, Southeast University

jinheguo@sina.com+86 13901599698

Outcome results

None listed

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