68Ga-N188 PET/CT Imaging in Malignancy

Peking University

Status: Enrolling

Conditions: Neoplasms

Treatments: Drug: [68Ga]N188

Study type: Interventional

Funder types: Other

Identifiers

NCT05593107

[68Ga]N188

Details and patient eligibility

About

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.

Enrollment: 203 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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203 participants in 1 patient group

[68Ga]N188

Experimental group

Description:

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.

Treatment:

Drug: [68Ga]N188