Viewing Study NCT05891028



Ignite Creation Date: 2024-05-06 @ 7:07 PM
Last Modification Date: 2024-10-26 @ 3:00 PM
Study NCT ID: NCT05891028
Status: RECRUITING
Last Update Posted: 2023-06-08
First Post: 2023-05-26

Brief Title: 64Cu68Ga Labelled EB-ss-CPT PETCT Scan in Colorectal Cancer
Sponsor: Peking Union Medical College Hospital
Organization: Peking Union Medical College Hospital

Study Overview

Official Title: 64Cu68Ga Labelled EB-ss-CPT PETCT Scan in Colorectal Cancer
Status: RECRUITING
Status Verified Date: 2023-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Positron labeled camptothecin based PET imaging is a new imaging technique that uses positron isotopes such as 68Ga64Cu for PETCT MR imaging It is expected to have significant clinical significance in staging and detecting primary and metastatic head and neck cancer oral cancer and colorectal cancer tumors
Detailed Description: CPT a botanical anticancer drug is a mechanism that inhibits DNA synthesis and thus exerts anticancer effects by using topoisomerase I as its target of action and has shown good efficacy in digestive system tumors and head and neck tumors etc Previous research result showed that amphiphilic EB-ss-CPT formed nanoparticles by self-assembly bound to albumin in vivo and released CPT by breaking disulfide bonds under high GSH conditions in tumor tissues effectively enhancing the pharmacokinetics and biodistribution of camptothecin thereby improving therapeutic efficacy and In this study the sensitivity of colorectal cancer cells to the drug was also demonstrated In this study 64Cu-NOTA-EB-ss-CPT hereafter 64Cu-EB-CPT was generated by posionuclide 64Cu-labelled EB-ss-CPT for PETCT imaging alone and showed better tumour enrichment compared to the 64Cu-labelled CPT group EB-CPT is expected to be more enriched in tumour tissue through the EPR effect of its nanoparticles and 64Cu is also a promising radionuclide for quantitative analysis using PETCT imaging The formation of 64Cu-EB-CPT or 68Ga-EB-CPT by labelling EB-CPT with the positronium nuclide 64Cu or 68Ga is expected to be enhanced by the EPR effect of the precursors the enhanced permeability and retention effect of solid tumours The EPR effect enhanced permeability and retention effect refers to the tendency of molecules or particles of certain sizes to accumulate in tumour tissue relative to normal tissue is expected to enrich the drug in the tumour area and allow early diagnosis of tumour patients by PETCT imaging with the preceding positronuclide 64Cu or 68Ga which can help in the staging of tumours and the development of treatment plans

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None