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Clinical Trial · NCT03385148
The Clinical Application of 68Ga Labeled ssDNA Aptamer Sgc8 in Healthy Volunteers and Colorectal Patients
Overview
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.
Sponsor
Xijing Hospital
Phase
Early Phase 1
Contacts
Zhe Wang, Dr. (CONTACT)
dadaxueshan@163.com
862984771048
Jing Wang, Dr. (STUDY_CHAIR)
ClinicalTrials.gov
NCT03385148Drug / Compound
Sgc8
Isotope(s):
GALLIUM-68
Radioisotope: Ga-68
Theranostic Role: PET Imaging
T1/2 (Half-Life): 68 minutes
Decay Mode: POSITRON β+ (88.9%), GAMMA, ELECTRON CAPTURE (8.7%)
Energy: Beta: max 1.9 MeV Gamma 1.1 MeV, 511 keV
Range: N/A
Decay Daughters: Zn68 (Stable)
Status: FDA Approvals: NETSPOT® (2016), LOCAMETZ® (2022), ILLUCIX® (2021)
Target(s):
- Protein tyrosine kinase 7 (PTK7)
Ligand Class: Small Molecules
Chelator: NOTA
Eligibility
Inclusion
- Newly diagnosed colorectal patients and lymph node metastasis is not clear. The tumor will be surgically removed and histological diagnosis will be available.
Exclusion
- Inability to lie still for the entire imaging time because of cough, pain, etc.
- Known severe allergy or hypersensitivity to IV radiographic contrast；
- 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.
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