Clinical trial NCT06602037: ImmunoPET Imaging of Pancreatic Cancer
Official title: Development and Clinical Translation of immunoPET Imaging Probes for Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms Pancreatic
Keywords: Pancreatic cancer
ImmunoPET
Companion Diagnostics
Trop2
CLDN18.2（Claudin 18.2）
Gastric cancer
Solid tumors
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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

Primary outcomes:
measure: SUV
timeFrame: 7 days
measure: Biodistribution and radiation dosimetry of [89Zr]Zr-DFO-SHR1920
timeFrame: 7 days
Secondary outcomes:
measure: Sensitivity, Specificity, Positive predictive value (PPV), Negative predictive value (NPV) and accuracy
timeFrame: 30 days
measure: Trop2 expression and SUV
timeFrame: 30 days
measure: CLDN18.2 expression and SUV
timeFrame: 30 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Study officials:
affiliation: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Jianjun Liu, PhD
role: STUDY_CHAIR
affiliation: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Weijun Wei, Ph.D. & M.D.
role: PRINCIPAL_INVESTIGATOR
References: