68Ga-N188 PET/CT Imaging in Malignancy

NCT05593107 · tracked via the Priya Life Science China tracker

Sponsor

Peking University First Hospital

Phase

Not applicable

Started

2022-08-12

Last updated

2024-11-21

Condition(s) studied

Neoplasms

Investigational drug(s) / intervention(s)

[68Ga]N188

[68Ga]N188: 68Ga-N188 is injected intravenously with a dose of 0.06-0.08 mCi/kg.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: * patients with confirmed or suspected cancer; * 18F-FDG PET/CT within 1 week; * Signed written informed consent. Exclusion Criteria: * Pregnant and lactating women; * Female patients plan to become pregnant within 6 months.

Primary outcome measure(s)

The diagnostic efficacy of 68Ga-N188 PET/CT in the evaluation of malignant tumors — 1 year
Compare the standardized Uptake Value (SUV) of lesions on 68Ga-N188 and 18F-FDG PET/CT
The diagnostic efficacy of 68Ga-N188 PET/CT in the evaluation of malignant tumors — 1 year
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.

Trial sites (1)

Facility	City	Region	Status
Peking University First Hospital	Beijing	Beijing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05593107 on ClinicalTrials.gov ↗ ← All trials in China