The Clinical Application of 68Ga Labeled ssDNA Aptamer Sgc8 in Healthy Volunteers and Colorectal Patients
Diagnostic Performance and Evaluation Efficacy of a Novel PTK7 PET Radiotracer 68Ga-SGC8
1 other identifier
interventional
70
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1 colorectal-cancer
Started Jan 2017
Typical duration for early_phase_1 colorectal-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2017
CompletedFirst Submitted
Initial submission to the registry
December 19, 2017
CompletedFirst Posted
Study publicly available on registry
December 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedDecember 28, 2017
January 1, 2017
12 months
December 19, 2017
December 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
diagnosis effecacy
Assess advantage or concordance of 68Ga-Sgc8 PET results with 18F-FDG PET imaging
2 years
Study Arms (1)
colorectal patients
EXPERIMENTALthe colorectal patients undergo 68Ga-Sgc8 PET/CT
Interventions
underwent a standard routine 18F-FDG PET/CT first, and then injected 10\~20 MBq 68Ga-Sgc8
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (2)
Xijing Hospital Nuclear Medicine Department
Xi'an, Shaanxi, 710032, China
Xijing Hospital
Xi'an, Shaanxi, 710032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jing Wang, Dr.
Xijing Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2017
First Posted
December 28, 2017
Study Start
January 1, 2017
Primary Completion
December 15, 2017
Study Completion
December 30, 2019
Last Updated
December 28, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share