68Ga-N188 PET/CT Imaging in Malignancy

Not Applicable

Recruiting

• Conditions: Neoplasms
• Interventions: Drug: [68Ga]N188

• Registration Number: NCT05593107
• Lead Sponsor: Peking University First Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-12
• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-23
• Study First Posted: 2022-10-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-21
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 203

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[68Ga]N188	[68Ga]N188	Subjects 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.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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
Correlation with pathological expression	1 year	Analyze Nectin-4 expression at the imaging level in combination with Nectin-4 expression in pathological specimens
Quantitative evaluation of 68Ga-N188	1 year	Evaluation of quantitative parameters of 68Ga-N188, such as time-activity curve.

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China