ImmunoPET Imaging of Pancreatic Cancers

Trial Title: ImmunoPET Imaging of Pancreatic Cancers

NCT ID: NCT06602037

Condition: Neoplasms Pancreatic

Conditions: Official terms:
Pancreatic Neoplasms

Conditions: Keywords:
Pancreatic cancer
ImmunoPET
Companion Diagnostics
Trop2
CLDN18.2（Claudin 18.2）
Gastric cancer
Solid tumors

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: [89Zr]Zr-DFO-SHR1920
Description: 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).
Arm group label: ImmunoPET imaging in patients with pancreatic cancers

Other name: [89Zr]Zr-SHR1920

Intervention type: Diagnostic Test
Intervention name: [18F]F-RESCA-3A12
Description: 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.
Arm group label: ImmunoPET imaging in patients with pancreatic cancers

Other name: [18F]F-3A12

Intervention type: Diagnostic Test
Intervention name: [68Ga]Ga-NOTA-3A12
Description: 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.
Arm group label: ImmunoPET imaging in patients with pancreatic cancers

Other name: [68Ga]Ga-3A12

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 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 was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy were 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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Address:
City: Shanghai
Zip: 200127
Country: China

Status: Recruiting

Contact:
Last name: Weijun Wei, PhD

Phone: 15000083153
Email: wwei@shsmu.edu.cn

Contact backup:
Last name: Shuxian An, PhD

Phone: 17717453484
Email: anshuxian@shsmu.edu.cn

Start date: July 13, 2024

Completion date: June 16, 2027

Lead sponsor:
Agency: RenJi Hospital
Agency class: Other

Source: RenJi Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06602037