99mTc-CNDG Injection in the Diagnosis of Malignant Tumors

September 3, 2023 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake value of 99mTc-CNDG in malignant tumors
Time Frame: through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Hongli Jing, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2023

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 3, 2023

First Submitted That Met QC Criteria

September 3, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K1999

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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