64Cu/68Ga Labelled EB-ss-CPT PET/CT Scan in Colorectal Cancer

NCT ID: NCT05891028

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-07
• Study Completion Date: 2023-08-31

Brief 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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

68Ga-EB-ss-CPT PET/CT scan

68Ga-EB-ss-CPT PET/CT scan Dosimetry study about 6 patients were injected with 3 (MBq) per kilogram body weight of 68Ga-EB-ss-CPT PET/CT in one dose intravenously and underwent wholebody scan at 5min#30min#60min#120min#240min, then analysis of dosimetric distribution ofradiopharmaceuticals in human body by HERMES software.

Group Type: EXPERIMENTAL

68Ga-EB-ss-CPT

Intervention Type: DRUG

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

64Cu-EB-ss-CPT PET/CT scan

64Cu-EB-ss-CPT PET/CT scan Dosimetry study about 6 patients were injected with 2 (MBq) per kilogram body weight of 64Cu-EB-ss-CPT PET/CT in one dose intravenously and underwent wholebody scan at 30min#8h#12h#24h#48h, then analysis of dosimetric distribution ofradiopharmaceuticals in human body by HERMES software.

Group Type: EXPERIMENTAL

64Cu-EB-ss-CPT

Intervention Type: DRUG

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

Interventions

68Ga-EB-ss-CPT

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

Intervention Type: DRUG

64Cu-EB-ss-CPT

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

Intervention Type: DRUG

Other Intervention Names

68Ga; 64Cu

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

• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhaohui Zhu

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

Chinese Academy of Medical Science & Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Rongxi Wang

Role: CONTACT

zhzwrx.123@163.com

+8615584172170

Zhaohui Zhu

Role: CONTACT

pumch_jacobwong@163.com

+8619800370331

Facility Contacts

Zhaohui Zhu, MD

Role: primary

pumch_jacobwong@163.com

+8619800370331

Other Identifiers

PUMCH-EB-CPT

Identifier Type: -

Identifier Source: org_study_id