ImmunoPET Imaging of Pancreatic Cancer

December 25, 2025 updated by: RenJi Hospital

Development and Clinical Translation of immunoPET Imaging Probes for Pancreatic Cancer

Pancreatic cancer remains one of the most aggressive cancer types. Target-specific targeted therapy is an attractive therapeutic alternative for the treatment of patients with a wide range of cancers, including pancreatic cancer. Companion diagnostic technique is critical for the success of targeted therapies. SHR-A1921 is a TROP2-directed antibody-drug-conjugate (ADC) approved for several clinical trials for advanced solid tumors. SHR1920 is the humanized anti-Trop2 monoclonal antibody (hIgG1) of SHR-A1921. Radio-labeling SHR1920 with radionuclide Zirconium-89 (89Zr) enables non-invasive imaging and quantification of SHR-A1921 distribution in cancer patients. Performing a [89Zr]Zr-DFO-SHR1920 PET scan before treatment with SHR-A1921 can evaluate tracer uptake in the primary and metastatic tumor lesions and normal organ distribution. CLND18.2 is another potential therapeutic target for pancreatic cancer. Target-specific immunoPET imaging may help identify patients more likely to benefit from targeted therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Enrolled patients with pancreatic cancer will undergo whole-body [89Zr]Zr-DFO-SHR1920 immunoPET/CT scans at 0,1, 3, 5, or 7 days after tracer injection (1-3 mCi). Uptake of [89Zr]Zr-DFO-SHR1920 in tumor and normal organs/tissues will be scored visually and quantitatively. For immunoPET imaging with 18F or 68Ga-labeled 3A12 (a nanobody targeting CLDN18.2), immunoPET/CT scan will be performed 1h after tracer injection (0.05-0.1 mCi/kg).

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)

90

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, 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:

  • Histologically confirmed diagnosis of pancreatic cancer or suspected pancreatic cancer by diagnostic imaging.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

  • Known or suspected hypersensitivity to SHR1920, DFO/RESCA/NOTA, 89Zr/18F or 68Ga or any of the excipients.
  • Pregnancy

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 pancreatic cancers
Enrolled pancreatic cancer patients (locally advanced or metastatic cancer) will undergo a Trop2/CLDN18.2-targeted immunoPET/CT scanning.
Diagnostic test: [89Zr]Zr-DFO-SHR1920
Enrolled pancreatic cancer patients will receive a single dose (1-3mCi) of [89Zr]Zr-DFO-SHR1920 (total 1-2mg antibody mass). Multiple immunoPET/CT imaging sessions will be performed on day 0, day 1(24 h), day 3 (72 h), day 5 (120 h) or day 7 (168 h).
Other Names:
  • [89Zr]Zr-SHR1920
Diagnostic test: [18F]F-RESCA-3A12
Enrolled pancreatic cancer patients will receive 0.05-0.1mCi/kg of [18F]F-RESCA-3A12. ImmunoPET/CT imaging will be acquired 1h after [18F]F-RESCA-3A12 injection.
Other Names:
  • [18F]F-3A12
Diagnostic test: [68Ga]Ga-NOTA-3A12
Enrolled pancreatic cancer patients will receive 0.05-0.1mCi/kg of [68Ga]Ga-NOTA-3A12. ImmunoPET/CT imaging will be acquired 1h after [68Ga]Ga-NOTA-3A12 injection.
Other Names:
  • [68Ga]Ga-3A12

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SUV
Time Frame: 7 days
Standardized uptake value (SUV) of [89Zr]Zr-DFO-SHR1920、[18F]F-RESCA-3A12 or [68Ga]Ga-NOTA-3A12 for each primary tumor of subject or suspected metastasis.
7 days
Biodistribution and radiation dosimetry of [89Zr]Zr-DFO-SHR1920
Time Frame: 7 days
Measurement of absorbed radiation doses to organs (Gy/MBq), tumour(s) and whole body (Sv/MBq).
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity, Specificity, Positive predictive value (PPV), Negative predictive value (NPV) and accuracy
Time Frame: 30 days
The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of [89Zr]Zr-DFO-SHR1920、[18F]F-RESCA-3A12 or [68Ga]Ga-NOTA-3A12 PET/CT will be calculated.
30 days
Trop2 expression and SUV
Time Frame: 30 days
The Standardized uptake value (SUV) of [89Zr]Zr-DFO-SHR1920 will be calculated and the correlation between pathological results and tumor uptake of [89Zr]Zr-DFO-SHR1920 will be analyzed
30 days
CLDN18.2 expression and SUV
Time Frame: 30 days
The Standardized uptake value (SUV) of [18F]F-RESCA-3A12 or [68Ga]Ga-NOTA-3A12 will calculated and the correlation between pathological results and tumor uptake of [18F]F-RESCA-3A12 or [68Ga]Ga-NOTA-3A12 will be analyzed.
30 days

Collaborators and Investigators

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

Sponsor

RenJi Hospital

Investigators

  • Study Chair: Jianjun Liu, PhD, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
  • Principal Investigator: Weijun Wei, Ph.D. & M.D., 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)

November 20, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

September 9, 2024

First Submitted That Met QC Criteria

September 15, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

December 29, 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

  • KY2024-067-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

product manufactured in and exported from the U.S.

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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