ImmunoPET Imaging of Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [89Zr]Zr-DFO-SHR1920, [18F]F-RESCA-3A12, [68Ga]Ga-NOTA-3A12.
- Who it may be relevant to
- Registry conditions: Neoplasms Pancreatic. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Development and Clinical Translation of immunoPET Imaging Probes for Pancreatic Cancer
Overview
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.
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.
Interventions
- 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). - 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. - 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.
Primary outcome measures
- SUV [Time frame: 7 days]
- Biodistribution and radiation dosimetry of [89Zr]Zr-DFO-SHR1920 [Time frame: 7 days]
Secondary outcome measures (3)
- Sensitivity, Specificity, Positive predictive value (PPV), Negative predictive value (NPV) and accuracy [Time frame: 30 days]
- Trop2 expression and SUV [Time frame: 30 days]
- CLDN18.2 expression and SUV [Time frame: 30 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai
Identifiers
NCT: NCT06602037 · KY2024-067-C