An interventional study of [89Zr]Zr-DFO-SHR1920 and [18F]F-RESCA-3A12 in Neoplasms Pancreatic, sponsored by RenJi Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by RenJi Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.
This study's planned enrollment of 90 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
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Exclusion Criteria:
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 · Diagnostic Test: [18F]F-RESCA-3A12 · Diagnostic Test: [68Ga]Ga-NOTA-3A12
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).
Also known as: [89Zr]Zr-SHR1920
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.
Also known as: [18F]F-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.
Also known as: [68Ga]Ga-3A12
SUV
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.
Time frame: 7 days
Biodistribution and radiation dosimetry of [89Zr]Zr-DFO-SHR1920
Measurement of absorbed radiation doses to organs (Gy/MBq), tumour(s) and whole body (Sv/MBq).
Time frame: 7 days
Sensitivity, Specificity, Positive predictive value (PPV), Negative predictive value (NPV) and accuracy
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.
Time frame: 30 days
Trop2 expression and SUV
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
Time frame: 30 days
CLDN18.2 expression and SUV
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.
Time frame: 30 days
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