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

Primary Purpose

Colorectal Cancer

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-EB-ss-CPT
64Cu-EB-ss-CPT
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Colorectal Cancer, PET/CT, CPT

Eligibility Criteria

undefined - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chinese Academy of Medical Science & Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

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

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Adverse events collection
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed

Full Information

First Posted
May 26, 2023
Last Updated
June 6, 2023
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05891028
Brief Title
64Cu/68Ga Labelled EB-ss-CPT PET/CT Scan in Colorectal Cancer
Official Title
64Cu/68Ga Labelled EB-ss-CPT PET/CT Scan in Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 7, 2023 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Cancer, PET/CT, CPT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-EB-ss-CPT PET/CT scan
Arm Type
Experimental
Arm Description
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.
Arm Title
64Cu-EB-ss-CPT PET/CT scan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
68Ga-EB-ss-CPT
Other Intervention Name(s)
68Ga
Intervention Description
68Ga-EB-ss-CPT were intravenous injected into the patients before PET/CT scans
Intervention Type
Drug
Intervention Name(s)
64Cu-EB-ss-CPT
Other Intervention Name(s)
64Cu
Intervention Description
64Cu-EB-ss-CPT were intravenous injected into the patients before PET/CT scans
Primary Outcome Measure Information:
Title
Dosimetric distribution of radiopharmaceuticals
Description
Input the data of 5-6 patients into HERMES software, and analyze the dose distribution of radioactive drugs in human body through HERMES software
Time Frame
2 months
Title
Standardized uptake value
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adverse events collection
Description
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed
Time Frame
1 year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rongxi Wang
Phone
+8615584172170
Email
zhzwrx.123@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaohui Zhu
Phone
+8619800370331
Email
pumch_jacobwong@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chinese Academy of Medical Science & Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, MD
Phone
+8619800370331
Email
pumch_jacobwong@163.com

12. IPD Sharing Statement

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

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