99mTc-CNDG Injection in the Diagnosis of Malignant Tumors

NCT ID: NCT06030817

Last Updated: 2023-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-11

Study Completion Date

2025-12-31

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.

Detailed Description

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Conditions

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Malignant Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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99mTc-CNDG SPECT/CT

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

Group Type EXPERIMENTAL

99mTc-CNDG SPECT/CT

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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99mTc-CNDG SPECT/CT

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

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hongli Jing

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongli Jing

Role: CONTACT

+86-18600586399

Facility Contacts

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Hongli Jing

Role: primary

+86-18600586399

Other Identifiers

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K1999

Identifier Type: -

Identifier Source: org_study_id

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