- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04883970
CLDN18.2 Targeting PET Imaging in Patients With Gastrointestinal Tumors
January 23, 2024 updated by: Hua Zhu, Peking University Cancer Hospital & Institute
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Beijing, China
- HUA ZHU
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Imaging cohort
All study participants will be allocated to this arm (single-arm study).
Study participants will undergo 124I-18B10(10L) PET/CT scans
|
Study participants will undergo 124I-18B10(10L) PET/CT scans
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Standardized uptake value(SUV)
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hua Zhu, Peking University Cancer Hospital & Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 13, 2021
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
May 1, 2024
Study Registration Dates
First Submitted
May 7, 2021
First Submitted That Met QC Criteria
May 7, 2021
First Posted (Actual)
May 12, 2021
Study Record Updates
Last Update Posted (Actual)
January 25, 2024
Last Update Submitted That Met QC Criteria
January 23, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021KT57
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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