Clinical Trial Details

Overview

Research Study Summary

Evaluation of the CytoRADx System as a Biodosimeter for Special Human Populations

Purpose

This study is designed to evaluate whether the dose results produced by the CytoRADx system are affected by immunocompromise (HIV), young age and by medical conditions that would accompany detonation of an IND or widespread radiation exposure; such as burns, sepsis, and trauma

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CW ID: 224180
Date Last Changed: April 19, 2017

Clinical Trial Snapshot

Gender
Both Male and Female
Age
2 to 7 Years
Overall Status
Recruiting
Facility Type
N/A

Eligibility

Inclusion Criteria:
  • Males or females ages 2 – 7 years, inclusive, with a minimum body weight of 13 kg
  • No evidence or diagnosis of chronic disease other than asthma
  • No prior chemotherapy or radiation therapy
  • Subject is willing and able to give verbal assent and parent or legal guardian signed informed consent to participate
  • Parent(s)/legal guardian(s) must provide written informed consent (parental permission) and subjects must provide written assent as appropriate for age per local IRB and 45 CFR 46 requirements prior to initiation of any study procedures.
Exclusion Criteria:
  • Subject has been admitted for medical care due to trauma within the last 21 days
  • Subject has been treated for burn encompassing more than 3% TBSA within the last 21 days
  • Medically diagnosed with infection or sepsis within the last 21 days
  • Subject has had a transfusion or received tissue products within 21 days of first blood draw

Contact

Research Center
Columbus Regional Research Institute
800 Talbotton Rd
Columbus, GA 31904
Phone: 706-321-0495

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