99mTc-CNDG SPECT/CT in Brain Tumors

Not Applicable

Recruiting

• Conditions: Intracranial Tumor

• Registration Number: NCT06362304
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

The goal of this clinical trial is to evaluate the value of 99mTc-CNDG for diagnosis of brain tumors by comparing it with 18F-FDG-PET. The main questions it aims to answer are:

1. What is the diagnostic consistency between 99mTc-CNDG and 18F-FDG?

2. What is the correlation between the SUVmax value of 99mTc-CNDG and tumor type?

Participants will:

Receive18F-FDG-PET and 99mTc-CNDG examination within 2 weeks before surgery. Obtain pathological diagnosis by surgery or biopsy as the gold standard.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-09
• Study First Posted: 2024-04-12
• Study Start: 2024-04-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-02
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with clinical diagnosis of brain tumor;
• Be at least 18 years old;
• The final pathological results could be obtained by surgery or biopsy;
• Informed consent and the ability to be followed up;
• Those who did not meet the exclusion criteria.

Exclusion Criteria

• Insulin-dependent diabetes mellitus or fasting blood glucose >7 mmol/L before 99mTc-CNDG injection;
• Severe liver or kidney disease (serum creatinine level >3.0mg/dL or any liver enzyme level ≥ 5 times the upper limit of normal);
• Severe hypersensitivity or hypersensitivity to radiocontrast agents;
• Claustrophobia (inability to undergo SPECT/CT or PET/CT scans);
• Patients receiving radiotherapy and chemotherapy;
• Being pregnant or breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
SUVmax	1month	1. Diagnostic consistency evaluation of 99mTc-CNDG and 18F-FDG; 2.Correlation of SUV value of 99mTc-CNDGwith tumor type

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China