68Ga-N188 PET/CT Imaging in Malignancy
A Study to Evaluate 68Ga-N188 PET/CT Imaging of Nectin-4 Expression in Malignant Tumors
1 other identifier
interventional
203
1 country
1
Brief Summary
The Nectin-4 protein belongs to the cell adhesion factors family and has a tissue-specific expression spectrum in normal human tissues. However, Nectin-4 is overexpressed in various malignancies, especially those of epithelial origins, such as uroepithelial carcinoma, making Nectin-4 a highly specific and significant imaging target for malignancies. \[68Ga\]N188, a novel molecular probe of PET imaging agent that targets Nectin-4, can be used in the diagnosis and research of a wide variety of Nectin-4 high-expression malignancies, including bladder cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 12, 2022
CompletedFirst Submitted
Initial submission to the registry
October 17, 2022
CompletedFirst Posted
Study publicly available on registry
October 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedNovember 21, 2024
October 1, 2024
3 years
October 17, 2022
November 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The diagnostic efficacy of 68Ga-N188 PET/CT in the evaluation of malignant tumors
Compare the standardized Uptake Value (SUV) of lesions on 68Ga-N188 and 18F-FDG PET/CT
1 year
The diagnostic efficacy of 68Ga-N188 PET/CT in the evaluation of malignant tumors
Compare the number of lesions detected by 68Ga-N188 and 18F-FDG PET/CT, based on the pathology or clinical follow-up as gold standard.
1 year
Secondary Outcomes (3)
The dosimetry of 68Ga-N188
1 year
Quantitative evaluation of 68Ga-N188
1 year
Correlation with pathological expression
1 year
Study Arms (1)
[68Ga]N188
EXPERIMENTALSubjects with suspected or confirmed malignancy will receive an intravenous injection of 68Ga-N188 followed by PET imaging. The subjects will also receive a whole-body 18F-FDG PET/CT scan within a one-week period.
Interventions
68Ga-N188 is injected intravenously with a dose of 0.06-0.08 mCi/kg.
Eligibility Criteria
You may qualify if:
- patients with confirmed or suspected cancer;
- F-FDG PET/CT within 1 week;
- Signed written informed consent.
You may not qualify if:
- Pregnant and lactating women;
- Female patients plan to become pregnant within 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 17, 2022
First Posted
October 25, 2022
Study Start
August 12, 2022
Primary Completion
July 31, 2025
Study Completion
July 31, 2025
Last Updated
November 21, 2024
Record last verified: 2024-10