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Image-guided surgery of Gliomas by indocyanine green fluorescence imaging navigation

Image-guided surgery of Gliomas by indocyanine green fluorescence imaging navigation

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000029402
Enrollment
Unknown
Registered
2020-01-29
Start date
2019-01-01
Completion date
Unknown
Last updated
2020-02-03

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

Conditions

Gliomas

Interventions

Sponsors

Chinese Academy of Sciences, Institute of Automation
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) The patient himself voluntarily signs the informed consent form; (2) Patients aged 18 and 75 years male and female; (3) Patients with glioma and have been considered to be suitable for tumor resection surgery.(The grade given by enhanced MRI has no limitations.); (4) Patients with a KPS score higher than 70; (5) Patients with normal heart function; (6) Patients with normal bone marrow reserve function and liver and kidney function, which are determined by laboratory tests before surgery. The test items and criteria are as follows: absolute neutrophil >=1,500/mm3; hemoglobin >10 g/dL; platelet count >100,000/mm3; total bilirubin level < 1.5 ULN; alanine aminotransferase/glutagory aminotransferase < 2.5 ULN; serum creatinine < 1.5 ULN; (7) Patients who are compatible with follow-up; (8) Women of child-bearing age (15 to 49 years old) must undergo a pregnancy test within 7 days prior to initiation of treatment with negative results; male and female patients with fertility must agree to use effective contraceptive measures to ensure no pregnancy during the study period and within 3 months after discontinuation of treatment.

Exclusion criteria

Exclusion criteria: (1) Patients who cannot sign the informed consent form voluntarily; (2) Patients who are not suitable for glioma resection surgery; (3) Allergic patients; (4) Patients with any unstable systemic disease (including active infections, uncontrolled high blood pressure, unstable angina, angina pectoris that has started within the last 3 months, congestive heart failure, occurred within the first 12 months of enrollment Myocardial infarction, severe arrhythmia requiring medication, liver, kidney or metabolic disease); (5) Patients who are infected with human immunodeficiency virus (HIV) or with active hepatitis; (6) Patients who have participated in other clinical trials within the past 30 days; (7) Patients with mental illness, cognitive impairment, who are unable to understand the experimental scheme and side effects and to complete the experimental arrangements and follow-up(systematic assessment is required before enrolled in the trial); (8) Patients with no personal freedom and capacity for civil conduct.

Design outcomes

Primary

MeasureTime frame
resection rate;

Secondary

MeasureTime frame
Sensitivity;Specificity;

Countries

China

Contacts

Public ContactHu Zhenhua

Chinese Academy of Sciences, Institute of Automation

zhenhua.hu@ia.ac.cn+86 13581998316

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 23, 2026