Gastrointestinal CancerNCT04883970
CLDN18.2 Targeting PET Imaging in Patients With Gastrointestinal Tumors
A study testing 124I-18B10(10L) PET/CT in people with Gastrointestinal Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
The objective of the study is to constrcut a noninvasive approach 124I-18B10(10L) PET/CT to detect the CLDN18.2 expression of tumor lesions in patients with gastrointestinal tumors and to identify patients benefiting from CLDN18.2 targeting treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- 124I-18B10(10L) PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2021to May 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Aged >18 years old; ECOG 0 or 1;
- 2. Patients with Gastrointestinal tumors;
- 3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
- 4. life expectancy >=12 weeks.
Who cannot join
- 1. Significant hepatic or renal dysfunction;
- 2. Is pregnant or ready to pregnant;
- 3. Cannot keep their states for half an hour;
- 4. Refusal to join the clinical study;
- 5. Suffering from claustrophobia or other mental diseases;
- 6. Any other situation that researchers think it is not suitable to participate in the experiment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CLDN18.2 Targeting 124I-18B10(10L) PET Imaging in Patients With Gastrointestinal Tumors
The objective of the study is to constrcut a noninvasive approach 124I-18B10(10L) PET/CT to detect the CLDN18.2 expression of tumor lesions in patients with gastrointestinal tumors and to identify patients benefiting from CLDN18.2 targeting treatment.
- Conditions
- Gastrointestinal Cancer
- Being tested
- 124I-18B10(10L) PET/CT
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
124I-18B10(10L) PET/CTOther
Study participants will undergo 124I-18B10(10L) PET/CT scans
| Study group | Role | What they receive |
|---|---|---|
| Imaging cohort | Experimental | All study participants will be allocated to this arm (single-arm study). Study participants will undergo 124I-18B10(10L) PET/CT scans Receives: Other: 124I-18B10(10L) PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value（SUV）
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start13 May 2021
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Zhu, Peking University Cancer Hospital & Institute
- Investigators
- Hua Zhu, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883970
- Sponsor's protocol ID
- 2021KT57
- Status last verified
- Jan 2024
- First submitted
- 7 May 2021
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang S, Qi C, Ding J, Li D, Zhang M, Ji C, Jiang F, Teng F, Yu J, Qian X, Wang F, Shen L, Gao J, Yang Z, Zhang C, Zhu H. First-in-human CLDN18.2 functional diagnostic pet imaging of digestive system neoplasms enables whole-body target mapping and lesion detection. Eur J Nucl Med Mol Imaging. 2023 Jul;50(9):2802-2817. doi: 10.1007/s00259-023-06234-z. Epub 2023 Apr 26.
PubMed 37099132
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLDN18.2 Targeting 124I-18B10(10L) PET Imaging in Patients With Gastrointestinal Tumors
- ClinicalTrials.gov ID
- NCT04883970
- Acronym / sponsor ID
- 2021KT57
- Conditions
- Gastrointestinal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 13 May 2021 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 12 May 2021 (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.
The objective of the study is to constrcut a noninvasive approach 124I-18B10(10L) PET/CT to detect the CLDN18.2 expression of tumor lesions in patients with gastrointestinal tumors and to identify patients benefiting from CLDN18.2 targeting treatment.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging cohort | Experimental | Other: 124I-18B10(10L) PET/CTAll study participants will be allocated to this arm (single-arm study). Study participants will undergo 124I-18B10(10L) PET/CT scans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Aged >18 years old; ECOG 0 or 1;
- 2. Patients with Gastrointestinal tumors;
- 3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
- 4. life expectancy >=12 weeks.
Key exclusion criteria (6 listed)
- 1. Significant hepatic or renal dysfunction;
- 2. Is pregnant or ready to pregnant;
- 3. Cannot keep their states for half an hour;
- 4. Refusal to join the clinical study;
- 5. Suffering from claustrophobia or other mental diseases;
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 |
|---|---|---|
| 124I-18B10(10L) PET/CTStudy participants will undergo 124I-18B10(10L) PET/CT scans | Other | Imaging cohort |
Primary outcome
Standardized uptake value（SUV）
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Derived from this study: PubMed 37099132Wang S, Qi C, Ding J, Li D, Zhang M, Ji C, Jiang F, Teng F, Yu J, Qian X, Wang F, Shen L, Gao J, Yang Z, Zhang C, Zhu H. First-in-human CLDN18.2 functional diagnostic pet imaging of digestive system neoplasms enables whole-body target mapping and lesion detection. Eur J Nucl Med Mol Imaging. 2023 Jul;50(9):2802-2817. doi: 10.1007/s00259-023-06234-z. Epub 2023 Apr 26.
- Individual participant dataSharing planned: Undecided
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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.
Hua Zhu principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 124I-18B10(10L) PET/CT in people with Gastrointestinal Cancer, run by Peking University Cancer Hospital & Institute 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 4 inclusion and 6 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 25 Jan 2024. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized uptake value（SUV） (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04883970, which also lists 1 linked publication.
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 25 Jan 2024.