99mTc-CNDG Injection in the Diagnosis of Malignant Tumors

Malignant Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06030817
• Other study ID #: K1999
• Status: Recruiting
• Phase: N/A
• Start date: August 11, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: Peking Union Medical College Hospital
• Contact: Hongli Jing
• Phone: +86-18600586399
• Email: annsmile1976[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Malignant Tumor
• Neoplasms

Intervention

Diagnostic Test:
• 99mTc-CNDG SPECT/CT
Explore the imaging characteristics of 99mTc-CNDG and its diagnostic efficacy in tumor patients.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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