68Ga-N188 PET/CT Imaging in Malignancy

A Study to Evaluate 68Ga-N188 PET/CT Imaging of Nectin-4 Expression in Malignant Tumors

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05593107

Enrollment

203

Registered

2022-10-25

Start date

2022-08-12

Completion date

2025-07-31

Last updated

2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

[68Ga]N188, Nectin-4, PET/CT, Neoplasms

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.

Interventions

DRUG[68Ga]N188

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Secondary

Measure	Time frame	Description
The dosimetry of 68Ga-N188	1 year	Research on the dose distribution of 68Ga-N188 in healthy volunteers and cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software
Quantitative evaluation of 68Ga-N188	1 year	Evaluation of quantitative parameters of 68Ga-N188, such as time-activity curve.
Correlation with pathological expression	1 year	Analyze Nectin-4 expression at the imaging level in combination with Nectin-4 expression in pathological specimens

Countries

China

Contacts

Primary ContactJianhua Zhang, Dr.

zjhjn820@163.com+861083572791

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026