Translational PET Imaging of Nectin-4 Expression in Multiple Different Cancers with 68Ga-N188.
Jianhua Zhang, Xiaojiang Duan, Xueqi Chen...
https://pubmed.ncbi.nlm.nih.gov/38719240Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05593107
A Study to Evaluate 68Ga-N188 PET/CT Imaging of Nectin-4 Expression in Malignant Tumors
Led by Peking University First Hospital · Updated on 2024-11-21
203
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Nectin-4 is a protein involved in cell adhesion that is found in specific normal tissues but is overexpressed in various cancers, especially those originating from epithelial cells such as uroepithelial carcinoma. This makes Nectin-4 a promising target for imaging to help diagnose and study these malignancies. Researchers are evaluating a new PET imaging agent called [68Ga]N188 that specifically targets Nectin-4 in cancers, including bladder cancer. In this study, participants with suspected or confirmed cancer will receive an intravenous injection of [68Ga]N188 at a dose of 0.06-0.08 mCi/kg. After the injection, they will undergo PET imaging using this agent. Additionally, participants will have a whole-body 18F-FDG PET/CT scan within one week to compare imaging results. This interventional study is conducted without masking or blinding. Participants will be monitored for up to one year to assess how well the [68Ga]N188 PET/CT scans diagnose malignant tumors. Researchers will also evaluate the radiation dose participants receive from [68Ga]N188, quantitatively analyze the imaging, and compare the imaging results with pathological findings of the tumors. The study involves informed consent, and safety is monitored throughout the trial period.
CONDITIONS
Brief Title
68Ga-N188 PET/CT Imaging in Malignancy
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patients with confirmed or suspected cancer
- 18F-FDG PET/CT scan within 1 week
- Signed written informed consent
You will not qualify if you...
- Pregnant and lactating women
- Female patients planning to become pregnant within 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Within 1 week
Participants receive an intravenous injection of 68Ga-N188 followed by PET imaging and a whole-body 18F-FDG PET/CT scan conducted within one week.
2 visits (in-person)
Long-term Monitoring
Duration - 1 year
Participants are monitored for diagnostic efficacy and safety outcomes over the course of 1 year.
Follow-up visits as needed
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
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Research Team
J
Jianhua Zhang, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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