99mTc-CNDG Injection in the Diagnosis of Malignant Tumors

NCT06030817 | Unknown

• 1 other identifier: K1999
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Tumor

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

99mTc-CNDG SPECT/CT

EXPERIMENTAL

Inject 99mTc-CNDG and then perform SPECT/CT scan.

Diagnostic Test: 99mTc-CNDG SPECT/CT

Interventions

99mTc-CNDG SPECT/CT DIAGNOSTIC_TEST

Explore the imaging characteristics of 99mTc-CNDG and its diagnostic efficacy in tumor patients.

99mTc-CNDG SPECT/CT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Hongli Jing

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongli Jing

CONTACT

+86-18600586399; annsmile1976@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2023
• First Posted: September 11, 2023
• Study Start: August 11, 2023
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 11, 2023

Record last verified: 2023-08

Locations

CN (1)