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Trial Title: 68Ga-N188 PET/CT Imaging in Malignancy

NCT ID: NCT05593107

Condition: Neoplasms

Conditions: Official terms:
Neoplasms

Conditions: Keywords:
[68Ga]N188
Nectin-4
PET/CT
Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: [68Ga]N188
Description: 68Ga-N188 is injected intravenously with a dose of 0.06-0.08 mCi/kg.
Arm group label: [68Ga]N188

Other name: 68Ga-N188

Other name: Nectin-4 specific PET imaging

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Peking University First Hospital

Address:
City: Beijing
Zip: 100034
Country: China

Status: Recruiting

Contact:
Last name: Jianhua Zhang

Phone: +861083572791
Email: zjhjn820@163.com

Investigator:
Last name: Jianhua Zhang, Dr.
Email: Principal Investigator

Start date: August 12, 2022

Completion date: July 31, 2025

Lead sponsor:
Agency: Peking University First Hospital
Agency class: Other

Source: Peking University First Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05593107

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