Colorectal CancerEarly Phase 1NCT05891028
64Cu/68Ga Labelled EB-ss-CPT PET/CT Scan in Colorectal Cancer
A Early Phase 1 study testing 68Ga-EB-ss-CPT and 64Cu-EB-ss-CPT in people with Colorectal Cancer, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- 68Ga-EB-ss-CPT and 64Cu-EB-ss-CPT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2023to 31 Aug 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe abnormalities in liver and kidney function
- Suffering from claustrophobia or other mental illnesses
- Pregnant, pregnant, and lactating women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Science & Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Zhaohui Zhu, MD, +8619800370331, pumch_jacobwong@163.com
About this study
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.
Read the 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
- Being tested
- 68Ga-EB-ss-CPT, 64Cu-EB-ss-CPT
- Keywords
- Colorectal Cancer, PET/CT, CPT
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-EB-ss-CPTDrug
Also called 68Ga
68Ga-EB-ss-CPT were intravenous injected into the patients before PET/CT scans
64Cu-EB-ss-CPTDrug
Also called 64Cu
64Cu-EB-ss-CPT were intravenous injected into the patients before PET/CT scans
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-EB-ss-CPT PET/CT scan | Experimental | 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. Receives: Drug: 68Ga-EB-ss-CPT |
| 64Cu-EB-ss-CPT PET/CT scan | Experimental | 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. Receives: Drug: 64Cu-EB-ss-CPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months
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.
Measured: 1 year
Secondary outcomes (1)
Adverse events collection
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start7 May 2023
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhaohui Zhu, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891028
- Sponsor's protocol ID
- PUMCH-EB-CPT
- Status last verified
- May 2023
- First submitted
- 26 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 64Cu/68Ga Labelled EB-ss-CPT PET/CT Scan in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05891028
- Acronym / sponsor ID
- PUMCH-EB-CPT
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, PET/CT, CPT
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 7 May 2023 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 68Ga-EB-ss-CPT PET/CT scan | Experimental | Drug: 68Ga-EB-ss-CPT68Ga-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 | Experimental | Drug: 64Cu-EB-ss-CPT64Cu-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. |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Severe abnormalities in liver and kidney function
- Suffering from claustrophobia or other mental illnesses
- Pregnant, pregnant, and lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-EB-ss-CPTAlso: 68Ga68Ga-EB-ss-CPT were intravenous injected into the patients before PET/CT scans | Drug | 68Ga-EB-ss-CPT PET/CT scan |
| 64Cu-EB-ss-CPTAlso: 64Cu64Cu-EB-ss-CPT were intravenous injected into the patients before PET/CT scans | Drug | 64Cu-EB-ss-CPT PET/CT scan |
Primary outcome
Dosimetric distribution of radiopharmaceuticals
Time frame: 2 months
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
Time frame: 1 year
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 secondary outcome
Adverse events collection
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaohui Zhu study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 68Ga-EB-ss-CPT and 64Cu-EB-ss-CPT in people with Colorectal Cancer, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongxi Wang (+8615584172170, zhzwrx.123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosimetric distribution of radiopharmaceuticals (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.