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A Single Centre Open Label Comparison of [I-123]-Ortho-Iodohippuric Acid (OIH) With [Tc-99m]-Mercaptoacetyltriglycine (MAG3) for Assessment of Renal Tubular Function

Information source: Centre for Probe Development and Commercialization
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Function Impairment

Phase: N/A

Status: Completed

Sponsored by: Centre for Probe Development and Commercialization

Official(s) and/or principal investigator(s):
Karen Gulenchyn, MD, Principal Investigator, Affiliation: St. Joseph's Healthcare Hamilton

Summary

Iodine-123 labelled ortho-Iodohippuric Acid ([I-123]-OIH) was used in the early 1970's as a kidney imaging agent or tracer that "lights-up" inside your body when scanned, but over the years its use has declined. The most commonly used tracer is Technetium-99m labelled Mercaptoacetyltriglycine ([Tc-99m]-Mertiatide or [Tc-99m]-MAG3). However, long-term shortages may threaten the supply of the radioactive substance Tc-99m in Canada and the world. As a result of such shortages, there is a need to identify other types of tracers that can be used for imaging. [I-123]-OIH may be an alternative. The purpose of this study is to examine the diagnostic performance characteristics of [I-123]-OIH in comparison to [Tc-99m]-MAG3.

Clinical Details

Official title: A Single Centre Open Label Comparison of [I-123]-Ortho-Iodohippuric Acid (OIH) With [Tc-99m]-Mercaptoacetyltriglycine (MAG3) for Assessment of Renal Tubular Function

Study design: Observational Model: Case Control, Time Perspective: Prospective

Primary outcome:

[I-123]-OIH Safety

Compare kidney function using [I-123]-OIH and [Tc-99m]-MAG3 imaging

Secondary outcome:

Qualitative Assessment

Image-derived Perfusion Data

eRPF

Detailed description: This study is being conducted to compare two imaging agents (tracers): [I-123]-OIH and [Tc-99m]-MAG3 using gamma camera imaging in participants with different levels of kidney function. Gamma camera imaging is a non-invasive nuclear scan that is used to look at organs and tissues inside the body. An imaging agent or tracer is a radioactive chemical intravenously injected into your body which lights up cells, tissues and organs. The study will evaluate the safety of a single injection of [I-123]-OIH and compare the imaging results and the calculated renal function values (using blood tests) to those of [Tc-99m]-MAG3 . 90 participants are required to complete this study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- At least 18 years of age.

- Provide signed informed consent.

- Documented stable renal impairment with an eGFR < 60/mL/min/1. 73m^2 by two eGFR

measurements within 3 months that are within ± 15% of each other or healthy prospective kidney donor with an eGFR ≥ 60 mL/min/1. 73m^2. Exclusion Criteria:

- Females who are pregnant, planning to become pregnant or are lactating.

- Clinically relevant abnormal findings that could, in the opinion of the investigator,

interfere with the safe completion of the study.

- Unable, in the opinion of the clinician or investigator, to tolerate fluid intake

required for radionuclide renography.

- Participation in any clinical trial involving an investigational product within 30

days prior to the first injection.

- Not using an adequate method of family planning unless the participant, or the male

participant's partner, has had a hysterectomy, a tubal ligation, is postmenopausal or is not at risk of pregnancy.

- Unable to lie still in a supine position for at least 30 minutes.

- Unable to complete study procedures, including follow-up safety assessments.

- Medical or psychological conditions that on assessment by the principal investigator

make the participant unable to complete the procedure.

- History of allergic reaction to iodine or iodine compounds, inclusive of iodinated

x-ray contrast media.

- Any other conditions that may impact the participant's ability to complete the study.

Locations and Contacts

St. Joesph's Healthcare Hamilton, Hamilton, Ontario L8N 4A6, Canada
Additional Information

Starting date: September 2012
Last updated: April 8, 2014

Page last updated: August 23, 2015

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