99mTc-CNDG SPECT/CT in Brain Tumors

Intracranial Tumor Clinical Trial

Official title:

Application of 99mTc-CNDG SPECT/CT Imaging in the Diagnosis of Brain Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06362304
• Other study ID #: 2024-DG-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Peking Union Medical College Hospital
• Contact: Zhaohui Zhu
• Phone: 01069154494
• Email: 13611093752[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Intracranial Tumor

Intervention

Diagnostic Test:
• 99mTc-CNDG SPECT/CT
FDG-PET and 99mTc-CNDG will be performed within 2 weeks before surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SUVmax	1. Diagnostic consistency evaluation of 99mTc-CNDG and 18F-FDG; 2.Correlation of SUV value of 99mTc-CNDGwith tumor type	1month