The Clinical Application of 68Ga Labeled ssDNA Aptamer Sgc8 in Healthy Volunteers and Colorectal Patients

• Status: Unknown status
• Trial end date: 2019-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The protein tyrosine kinase-7 (PTK7) is overexpressed in various types of human cancers. As a specific imaging agent of PTK7, 68Ga-Sgc8 was investigated in this study to assess its safety, biodistribution and dosimetric properties in healthy volunteers, and to preliminarily evaluate its application in colorectal patients.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Xijing Hospital

Criteria

Inclusion Criteria:

• Must be able to provide a written informed consent

• Males and females, ≥18 years old；

• Newly diagnosed colorectal patients and lymph node metastasis is not clear. The tumor will be surgically removed and histological diagnosis will be available.

Exclusion Criteria:

• Females planning to bear a child recently or with childbearing potential；

• Known severe allergy or hypersensitivity to IV radiographic contrast；

• Inability to lie still for the entire imaging time because of cough, pain, etc.

• Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.

• Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.