99mTc-CNDG SPECT/CT in Brain Tumors

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06362304
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Peking Union Medical College Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Intracranial Tumor

Arms & Interventions

Arms

Experimental: intracranial tumor

Interventions

Diagnostic Test: - 99mTc-CNDG SPECT/CT

FDG-PET and 99mTc-CNDG will be performed within 2 weeks before surgery.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Zhaohui Zhu

[email protected]

01069154494

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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