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Molecular targeted spectroscopy for the diagnosis of human glioma

Molecular targeted spectroscopy for the diagnosis of human glioma

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116671
Enrollment
Unknown
Registered
2026-01-13
Start date
2024-03-07
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Glioma

Interventions

IDH-mutant with 1p19q-codeletion:NA
Ki67<10%:NA
High-grade:NA
IDH-mutant:NA
Low-grade:NA
IDH-wild:NA
Ki67=10%:NA

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. patients admitted with gliomatosis cerebri; Clinical manifestations: headache, vomiting, seizures, limb weakness, sensory disturbance, visual field changes, mental and behavioral abnormalities and other gliomatosis cerebri related symptoms. Previous imaging data: head CT or MRI showed that there were imaging features of gliomatosis cerebri in the brain, such as diffuse and multifocal abnormal signals, involving multiple brain lobes, etc. 2. Older than 18 years old: there is no upper limit for older than 18 years old; 3. conscious: Glasgow Coma scale (GCS) score 15, able to communicate and cooperate normally; 4. Newly diagnosed glioma patients: have not received any treatment for glioma, including surgical resection, radiotherapy, chemotherapy (such as temozolomide, etc.), targeted therapy (such as bevacizumab, etc.), immunotherapy, etc. 5. Normal liver and kidney function: Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were within the normal reference range (the reference values may be slightly different in different testing institutions, generally ALT was 9-50 U/L in men and 7-40 U/L in women; AST 15-40 U/L in male and 13-35 U/L in female). Total bilirubin (TBIL) 1.7-17.1 µmol/L; Direct bilirubin (DBIL) 0-6.8 µmol/L; Albumin (ALB) 35-55 g/L; Renal function: serum creatinine (Scr) 53-106 µmol/L in male, 44-97 µmol/L in female; Blood urea nitrogen (BUN) 2.86-7.14 mmol/L; Estimated glomerular filtration rate (eGFR) >=90ml/ (min · 1.73m²);

Exclusion criteria

Exclusion criteria: 1. For patients with severe symptoms, the MRI scan time is longer and the head should be kept still during the scan The presence of frequent status epilepticus (seizures lasting more than 30 minutes, or frequent seizures without regaining consciousness between seizures) should be excluded. Severe symptoms of intracranial hypertension, such as severe headache, frequent ejection vomiting, accompanied by disturbance of consciousness (GCS score < 13); Severe limb paralysis and inability to cooperate voluntarily to keep the head still. 2. Allergic constitution: previous history of severe drug allergy (such as penicillin anaphylactic shock, etc.), food allergy history, and unexplained allergic reactions within the past 3 months; 3. Claustrophobia: patients report symptoms such as fear, anxiety, and dyspnea when entering a small, closed space (such as magnetic resonance imaging), or show claustrophobia when passing simple psychological tests (such as simulated closed space experience).

Design outcomes

Primary

MeasureTime frame
The presence or absence of molecules;Ki67 proliferation index;Tumor grade;molecular subtyping;

Secondary

MeasureTime frame
molecular concentration;

Countries

China

Contacts

Public ContactYao Zhenwei

Huashan Hospital, Fudan University

aocnhnr@126.com+86 21 52888050

Outcome results

None listed

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