- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06203613
Clinical Study of CLDN18.2 PET/CT for Noninvasive Diagnosis of Gastric and Pancreatic Cancer
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yihui Guan, MD
- Phone Number: +86 13764308300
- Email: guanyihui@hotmail.com
Study Locations
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Shanghai, China, 200235
- Recruiting
- PET Center, Huashan Hospital, Fudan University
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Contact:
- Yi Hui Guan, MD
- Phone Number: 128 86-21-64285263
- Email: guanyihui@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
(1) Age between 18 and 65 years old, gender is not limited. (2) Patients with gastric or pancreatic cancer confirmed by puncture or surgical pathology.
(3) Written informed consent signed by the subject or his/her legal guardian or caregiver.
(4) Willingness and ability to cooperate with all programs of this study.
Exclusion Criteria:
- (1) Severe hepatic or renal insufficiency; (2) Targeted therapy before radiotherapy or PET/CT scan. (3)Renal function: serum creatinine less than or equal to the upper limit of the normal range;Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.
(4) History of serious surgery in the last month. (5) Those who have participated in other clinical trials during the same period.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: patients with gastric cancer
Subjects were recruited from the Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, China.
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The dose of [18F]RCCB6 was calculated based on the patient's body weight to be 3.7 MBq [0.1 MCi]/kg, and the method of administration was intravenous push, with a single visualization administered once.
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Experimental: patients with pancreatic cancer
Subjects were recruited from the Department of General Surgery, Huashan Hospital, Fudan University, Shanghai, China.
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The dose of [18F]RCCB6 was calculated based on the patient's body weight to be 3.7 MBq [0.1 MCi]/kg, and the method of administration was intravenous push, with a single visualization administered once.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the sensitivity and specificity of using [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 for the diagnosis of metastatic gastric and pancreatic cancer
Time Frame: 90mins from time of injection
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In this study, we will first investigate the safety and feasibility of [18F]F-H3RESCA-3A12 and [68Ga]Ga-NOTA-3A12 in metastatic gastric and pancreatic cancers.
The secondary goal of the clinical trial is to preliminary assess the sensitivity and specificity of using [18F]F-H3RESCA-3A12 or [68Ga]Ga-NOTA-3A12 PET/CT imaging for the diagnosis of metastatic gastric or pancreatic cancers.
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90mins from time of injection
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fang Xie, PhD, Huashan Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY2023-1015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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