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NCT Number: NCT06602037

ImmunoPET Imaging of 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.

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Key information

Conditions

Neoplasms Pancreatic Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Stomach Diseases Stomach Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[89Zr]Zr-DFO-SHR1920

Diagnostic Test

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

[18F]F-RESCA-3A12

Diagnostic Test

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

[68Ga]Ga-NOTA-3A12

Diagnostic Test

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

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shuxian An, Ph.D. & M.D.

CONTACT

[email protected]

17717453484

Weijun Wei, Ph.D. & M.D.

CONTACT

[email protected]

15000083153

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Development and Clinical Translation of immunoPET Imaging Probes for Pancreatic Cancer

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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