68Ga-labeled Cholecystokinin Receptor (CCK2R) Targeted Molecular Probes in Early Tumor Diagnosis

October 29, 2026 updated by: Feng Wang, Nanjing First Hospital, Nanjing Medical University

Clinical Application Research of 68Ga-labeled Cholecystokinin Receptor (CCK2R) Targeted Molecular Probes in Early Tumor Diagnosis

Evaluate the safety of the novel radioactive nuclide-labeled cholecystokinin receptor (CCK2R) targeted molecular probe, 68Ga-YQ-CC05, in clinical application, and verify its effectiveness in tumor diagnosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

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
    • Jiangsu
      • Nanjing, Jiangsu, China, 210001
        • Recruiting
        • Nanjing First 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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants were recruited through hospital electronic records and community health centers

Description

Inclusion Criteria:

  • Volunteer to participate in the trial, with the patient or their legal guardian signing the informed consent form;
  • Volunteers are not limited by gender, and the age range is from 18 to 75 years old, inclusive;
  • Other imaging examination methods (CT, MRI, etc.) reveal tumor occupying lesions;
  • Tumor patients who can obtain the final pathological results.
  • Kidney: GFR > 50 ml/min, ERPF > 280 ml/min, platelet count (PLT) > 75,000/μL, white blood cell (WBC) > 3,000/μL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 3 times the normal value.

Exclusion Criteria:

  • Individuals with a history of allergy to similar drugs (drugs with similar chemical or biological components to CCK2R), allergic constitution, or current allergic diseases;
  • Those who are currently participating in other clinical drug studies, or have previously participated in any clinical drug studies (excluding vitamins and minerals);
  • Other uncontrollable clinical issues (such as HIV, hepatitis C virus infection, active hepatitis B, or other severe chronic infections, as well as severe mental, neurological, cardiovascular, respiratory, and other systemic diseases);
  • Red blood cells (RBC) count less than 4×10^12, white blood cells (WBC) count less than 3×10^9, hemoglobin level less than 110g/L, and platelet count (PLT) less than 75,000×10^9;
  • Obvious abnormalities in liver and kidney function, with GFR less than 50 ml/min;
  • Tumor burden greater than 50%, or significant spinal cord compression;
  • Expected survival duration less than half a year; chemotherapy within 6 months;
  • Having severe acute concomitant diseases or severe treatment-resistant mental disorders;
  • Pregnant and lactating women (where pregnancy is defined as a positive urine pregnancy test result);
  • Patients who are physically unfit for radiological examinations;
  • Other situations where the researcher deems it inappropriate for the participant to participate in the trial.

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

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SUVmax of lesion uptake value
Time Frame: 60 minutes after administration
60 minutes after administration

Collaborators and Investigators

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

Sponsor

Nanjing First Hospital, Nanjing Medical University

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 1, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

October 29, 2026

First Submitted That Met QC Criteria

October 29, 2026

First Posted (Actual)

November 4, 2026

Study Record Updates

Last Update Posted (Actual)

November 4, 2026

Last Update Submitted That Met QC Criteria

October 29, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20250327-2

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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