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Trial Title:
64Cu/68Ga Labelled EB-ss-CPT PET/CT Scan in Colorectal Cancer
NCT ID:
NCT05891028
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Colorectal Cancer
PET/CT
CPT
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-EB-ss-CPT
Description:
68Ga-EB-ss-CPT were intravenous injected into the patients before PET/CT scans
Arm group label:
68Ga-EB-ss-CPT PET/CT scan
Other name:
68Ga
Intervention type:
Drug
Intervention name:
64Cu-EB-ss-CPT
Description:
64Cu-EB-ss-CPT were intravenous injected into the patients before PET/CT scans
Arm group label:
64Cu-EB-ss-CPT PET/CT scan
Other name:
64Cu
Summary:
Positron labeled camptothecin based PET imaging is a new imaging technique that uses
positron isotopes such as 68Ga/64Cu for PET/CT (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 PET/CT 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 PET/CT 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 PET/CT imaging with the preceding positronuclide
64Cu or 68Ga, which can help in the staging of tumours and the development of treatment
plans.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- In the near future (within 2 months), patients who plan to undergo puncture biopsy
or undergo tumor surgical treatment or are clinically highly suspected of cancer
(including primary and tumor recurrence and metastasis)
- Able to understand and voluntarily sign informed consent forms, with good compliance
Exclusion Criteria:
- Severe abnormalities in liver and kidney function
- Suffering from claustrophobia or other mental illnesses
- Pregnant, pregnant, and lactating women
Gender:
All
Minimum age:
N/A
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese Academy of Medical Science & Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhaohui Zhu, MD
Phone:
+8619800370331
Email:
pumch_jacobwong@163.com
Start date:
May 7, 2023
Completion date:
August 31, 2023
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05891028
