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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05891028
Other study ID # PUMCH-EB-CPT
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date May 7, 2023
Est. completion date August 31, 2023

Study information

Verified date May 2023
Source Peking Union Medical College Hospital
Contact Rongxi Wang
Phone +8615584172170
Email zhzwrx.123@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
68Ga-EB-ss-CPT
68Ga-EB-ss-CPT were intravenous injected into the patients before PET/CT scans
64Cu-EB-ss-CPT
64Cu-EB-ss-CPT were intravenous injected into the patients before PET/CT scans

Locations

Country Name City State
China Chinese Academy of Medical Science & Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dosimetric distribution of radiopharmaceuticals Input the data of 5-6 patients into HERMES software, and analyze the dose distribution of radioactive drugs in human body through HERMES software 2 months
Primary Standardized uptake value The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in breast tumor will be measured. SUV were obtained by a self-made software and referring to phantom study.If the SUV value cannot be obtained, the COUNTS of target organ/background ratio between the lesion and surrounding tissues shall be used for calculation. 1 year
Secondary Adverse events collection Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed 1 year
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