Target-specific immunoPET Imaging of Digestive System Carcinoma

December 25, 2025 updated by: RenJi Hospital

Development and Clinical Translation of immunoPET Imaging Probes for Digestive System Carcinoma

The aim of this study is to establish and optimize the target-specific PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in digestive system malignant tumors will be evaluated.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Enrolled patients will undergo whole-body PET/CT scans at 1 hours after tracer injection(0.05-0.1 mCi/kg). Uptake of above imaging agents in tumor and normal organs/tissues will be scored visually and quantitatively.

Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to evaluate the diagnostic efficacy. The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. The exploration endpoint will be the imaging feasibility and preliminary diagnostic value of the above tracers.

Study Type

Interventional

Enrollment (Estimated)

400

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 Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200127
        • Recruiting
        • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Contact:
        • 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:

  1. Aged 18-75 years old and of either sex；
  2. Histologically confirmed diagnosis of digestive system carcinoma or suspected digestive system carcinoma by diagnostic imaging;
  3. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.

Exclusion Criteria:

  1. Pregnancy；
  2. Severe hepatic and renal insufficiency;
  3. History of serious surgery in the last month;
  4. Allergic to antibody or single-domain antibody radiopharmaceuticals.

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: ImmunoPET imaging in patients with digestive system carcinoma
Enrolled patients will undergo a targeted-specific immunoPET/CT scanning.
Drug: [68Ga]Ga-DOTA-H2D3
Enrolled patients (especially those with gastric cancer) will receive 0.05-0.1 mCi/kg of a HER2-targeted probe ([68Ga]Ga-DOTA-H2D3). ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-DOTA-H2D3 injection.
Other Names:
  • [68Ga]Ga-H2D3
Drug: [18F]F-RESCA-RB14
Enrolled patients (especially those with gastric cancer) will receive 0.05-0.1 mCi/kg of a HER2-targeted probe ([18F]F-RESCA-RB14). ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-RB14 injection.
Other Names:
  • [18F]F-RB14
Drug: [68Ga]Ga-NOTA-T4
Enrolled patients (especially those with gastric cancer/pancreatic cancer) will receive 0.05-0.1 mCi/kg of a Trop2-targeted probe ([68Ga]Ga-NOTA-T4). ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-T4 injection.
Other Names:
  • [68Ga]Ga-T4
Drug: [18F]F-RESCA-T4
Enrolled patients (especially those with gastric cancer/pancreatic cancer) will receive 0.05-0.1 mCi/kg of a Trop2-targeted probe ([18F]F-RESCA-T4). ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-T4 injection.
Other Names:
  • [18F]F-T4
Drug: [68Ga]Ga-NOTA-G5
Enrolled patients (especially those with hepatocellular carcinoma) will receive 0.05-0.1 mCi/kg of a GPC3-targeted probe ([68Ga]Ga-NOTA-G5). ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-G5 injection.
Other Names:
  • [68Ga]Ga-G5
Drug: [18F]F-RESCA-G5
Enrolled patients (especially those with hepatocellular carcinoma) will receive 0.05-0.1 mCi/kg of a GPC3-targeted probe ([18F]F-RESCA-G5). ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-G5 injection.
Other Names:
  • [18F]F-G5
Drug: [68Ga]Ga-NOTA-WWH347
Enrolled patients (especially those with colorectal cancer) will receive 0.05-0.1 mCi/kg of a GPA33-targeted probe ([68Ga]Ga-NOTA-WWH347). ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-WWH347 injection.
Other Names:
  • [68Ga]Ga-WWH347
Drug: [18F]F-RESCA-WWH347
Enrolled patients (especially those with colorectal cancer) will receive 0.05-0.1 mCi/kg of a GPA33-targeted probe ([18F]F-RESCA-WWH347). ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-WWH347 injection.
Other Names:
  • [18F]F-WWH347
Drug: [68Ga]Ga-NOTA-RND20
Enrolled patients will receive 0.05-0.1 mCi/kg of a Nectin-4-targeted probe ([68Ga]Ga-NOTA-RND20). ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-RND20 injection.
Other Names:
  • [68Ga]Ga-RND20
Drug: [18F]F-RESCA-RND20
Enrolled patients will receive 0.05-0.1 mCi/kg of a Nectin-4-targeted probe ([18F]F-RESCA-RND20). ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-RND20 injection.
Other Names:
  • [18F]F-RND20

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biodistribution
Time Frame: 1 day from injection of the tracers
Measurement of the overall biodistribution of above tracers in normal tissues and organs.
1 day from injection of the tracers
Standardized uptake value (SUV)
Time Frame: 1 day from injection of the tracers
Standardized uptake value (SUV) of above tracers in the included subjects' primary and/or metastatic lesions.
1 day from injection of the tracers
Radiation dosimetry
Time Frame: 1 day from injection of the tracers
Measurement of absorbed radiation doses (Gy/MBq) to tissues/organs, tumor(s), and whole body (Sv/MBq). Dynamic imaging within one hour will be acquired for the purpose.
1 day from injection of the tracers
Diagnostic value in patients with digestive system malignancy
Time Frame: 30 days
Systematic evaluation of these parameters will elucidate the pharmacokinetics, pharmacodynamics and, more importantly, the clinical value of these target-specific tracers in patients with malignancies of the digestive system.
30 days
The correlation between the expression of specific target and tracer uptake value
Time Frame: 60 days
The Standardized uptake value (SUV) will be calculated, and the correlation between pathological results and tumor uptake of these tracers will be analyzed.
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive value of these tracers in the course of combined immunotherapies and targeted therapies
Time Frame: 3-6 months
Baseline and follow-up immunoPET imaging in combined immunotherapies and targeted therapies (four to eight cycles) will be investigated in this setting to determine the value of the immunoPET imaging in predicting or evaluating treatment responses.
3-6 months
Target-specific PET/CT in changing clinical decision-making for patients with digestive system malignancy
Time Frame: 3-6 months
After analyzing the imaging parameters and diagnostic/predictive value of these target-specific tracers, we will also investigate how clinical use of these tracers changes clinical decision-making for patients with malignant tumors of the digestive system. Joint efforts from nuclear medicine physicians, surgeons, oncologists, and pathologists will draw solid conclusions from the imaging and clinical information.
3-6 months

Collaborators and Investigators

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

Sponsor

RenJi Hospital

Investigators

  • Study Chair: Weijun Wei, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong 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)

December 4, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

November 29, 2024

First Submitted That Met QC Criteria

November 29, 2024

First Posted (Actual)

December 4, 2024

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 25, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2024-107-C

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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