- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05691855
89Zr-labeled NY009 PET Imaging in Patients
January 19, 2023 updated by: Chunjing Yu, Affiliated Hospital of Jiangnan University
This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled NY009 PET Imaging in patients
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chunjing Yu
- Phone Number: 15312238622
- Email: ycj_wxd1978@163.com
Study Locations
-
-
-
Wuxi, China, 214000
- Recruiting
- Affiliated Hospital of Jiangnan University
-
Contact:
- Chunjing Yu
- Phone Number: 15312238622
- Email: ycj_wxd1978@163.com
-
-
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 to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients voluntarily signed informed consent;
- Age 18-75, male or female;
- Patients diagnosed with cancer confirmed by histopathology or cytology;
- At least one measurable solid lesion has been examined according RECIST1.1 standard;
- ECOG score 0~2.
Exclusion Criteria:
- Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
- Patients with systemic or locally severe infections, or other serious coexisting diseases;
- Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
- Patients with autoimmune diseases, including rheumatoid arthritis;
- Inadequate control of arrhythmias, including atrial fibrillation;
- Uncontrolled hypertension;
- Patients with allergies or allergies to any component of the imaging agent or antibody;
- Patients who cannot undergo PET/CT imaging scan;
- Syphilis, HBV, HCV, or HIV positive subjects;
- Male and female subjects of reproductive age cannot take effective contraceptive measures;
- Pregnant or lactating women;
- Patients with a history of mental illness or related conditions;
- Other subjects considered unsuitable by researchers.
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: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 89Zr-NY009
|
Patients will receive a tracer (5-10mg, IV) dose of 89Zr (2-3mCi) labelled NY009
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of tissue distribution of 89Zr-NY009
Time Frame: 7 days
|
Biodistribution of 89Zr-NY009 evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 89Zr-PET scans will be reported.
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chunjing Yu, Affiliated Hospital of Jiangnan University
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)
June 1, 2022
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
January 11, 2023
First Submitted That Met QC Criteria
January 19, 2023
First Posted (Actual)
January 20, 2023
Study Record Updates
Last Update Posted (Actual)
January 20, 2023
Last Update Submitted That Met QC Criteria
January 19, 2023
Last Verified
December 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- LS2020002
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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