99mTc-CNDG Injection in the Diagnosis of Malignant Tumors

Study Overview
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Brief Summary
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Currently, 18F-fluorodeoxyglucose (18F-FDG) is the most widely used tumor imaging agent in clinical practice. However, the production of 18F requires accelerators and is associated with relatively high diagnostic costs, which to some extent limits its widespread clinical application. In comparison to Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT) devices are more abundant and offer lower diagnostic expenses. With the utilization of Cadmium Zinc Telluride (CZT) crystals in SPECT and advancements in image reconstruction techniques, the resolution and sensitivity of SPECT is continually improving. Therefore, the development of a simplified and cost-effective novel SPECT tumor imaging agent holds significant practical significance. This study involved the design and synthesis of a glucose-derived ligand with a linker containing seven methylene units and an isonitrile group (CN7DG). The CN7DG ligand was labeled with 99mTc to prepare a more lipophilic 99mTc-CN7DG complex, aiming to investigate a novel SPECT imaging agent for tumor imaging.

Official Title
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A Prospective Study to Explore the Performance and Efficacy of 99mTc-CNDG Injection in Malignant Tumors

Conditions
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Malignant Tumor

Intervention / Treatment
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* Diagnostic Test: 99mTc-CNDG SPECT/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-70 years old Patients diagnosed with malignant glioma, colorectal cancer, pancreatic cancer, lung cancer, breast cancer, or other malignant tumors through imaging techniques such as MRI, CT, and ultrasound, and who are scheduled for surgical resection or biopsy Solid tumor sizes greater than 2cm Voluntarily agree to participate and sign an informed consent form Can provide complete surgical records, pathological results, control data, and clinical follow-up results Exclusion Criteria: Pre-treatment such as chemotherapy and targeted therapy has been administered Pregnancy and breastfeeding Claustrophobia The condition is severe and difficult to cooperate with Unable to obtain relevant control imaging data and clinical information

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 99mTc-CNDG SPECT/CT<br>Inject 99mTc-CNDG and then perform SPECT/CT scan. | Diagnostic Test: 99mTc-CNDG SPECT/CT<br>* Explore the imaging characteristics of 99mTc-CNDG and its diagnostic efficacy in tumor patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake value of 99mTc-CNDG in malignant tumors | The uptake value was measured in the malignant lesions on 99mTc-CNDG SPECT/CT. | through study completion, an average of 1 year | 
| Lesions detected by 99mTc-CNDG SPECT/CT | The number of target lesions was calculated by 99mTc-CNDG SPECT/CT | through study completion, an average of 1 year | 
| Compared with 18F-FDG PET/CT or CECT | The number of lesions detected by 99mTc-CNDG SPECT/CT was compared with 18F-FDG PET/CT or CECT | through study completion, an average of 1 year |