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CLDN18.2 Targeting Nanobody Probe for PET Imaging in Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05436093
Recruitment Status : Recruiting
First Posted : June 28, 2022
Last Update Posted : June 28, 2022
Sponsor:
Information provided by (Responsible Party):
Hua Zhu, Peking University Cancer Hospital & Institute

Brief Summary:
The objective of the study is to construct a noninvasive approach 68Ga-ACN376 PET/CT to detect the CLDN18.2 expression of tumor lesions in patients with Solid tumors and to identify patients benefiting from CLDN18.2 targeting treatment.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: 18F-FDG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: CLDN18.2 Targeting Nanobody Probe for PET Imaging in Solid Tumors
Actual Study Start Date : June 23, 2022
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 68Ga-ACN376
Imaging cohort All study participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-ACN376 PET/CT scan.
Drug: 18F-FDG
All study participants will undergo one 18F-FDG PET/CT scan.




Primary Outcome Measures :
  1. Standardized uptake value(SUV) [ Time Frame: 2 years ]
    SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions。 The uptake of the tracer (68Ga-ACN376) in solid tumor lesions by measuring SUV on PET/CT.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Aged >18 years old; ECOG 0 or 1;
  • 2. Patients with solid 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05436093


Contacts
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Contact: Hua Zhu 010-88196495 zhuhuabch@pku.edu.cn

Locations
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China, Beijing
Beijing cancer hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Hua Zhu    010-88196495    zhuhuabch@pku.edu.cn   
Sponsors and Collaborators
Peking University Cancer Hospital & Institute
Investigators
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Principal Investigator: Hua Zhu Peking University Cancer Hospital & Institute
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Responsible Party: Hua Zhu, Associate Professor, Peking University Cancer Hospital & Institute
ClinicalTrials.gov Identifier: NCT05436093    
Other Study ID Numbers: 2022KT96
First Posted: June 28, 2022    Key Record Dates
Last Update Posted: June 28, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action