Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602037
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
ImmunoPET Imaging of Pancreatic Cancers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development and Clinical Translation of ImmunoPET Imaging Probes for Pancreatic Cancers
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 89ZrZr-DFO-SHR1920 PET scan before treatment with SHR-A1921 can evaluate tracer uptake in the primary and metastatic tumor lesions and normal organ distribution CLND182 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 89ZrZr-DFO-SHR1920 immunoPETCT scans at 01 3 5 or 7 days after tracer injection 1-3 mCi Uptake of 89ZrZr-DFO-SHR1920 in tumor and normal organstissues will be scored visually and quantitatively For immunoPET imaging with 18F or 68Ga-labeled 3A12 a nanobody targeting CLDN182 immunoPETCT scan will be performed 1h after tracer injection 005-01 mCikg
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None