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

Completed

• Conditions: Renal Function Impairment

• Registration Number: NCT01496391
• Lead Sponsor: Centre for Probe Development and Commercialization

Brief 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.

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.

Study Timeline

• Study First Submitted: 2011-12-18
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-21
• Study Start: 2012-09
• Primary Completion: 2013-05
• Status Verified: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-08
• Last Update Posted: 2014-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare kidney function using [I-123]-OIH and [Tc-99m]-MAG3 imaging	Visit 2 and 3	Compare results of renal plasma flow derived from \[I-123\]-OIH and \[Tc-99m\]-MAG3 gamma camera images of healthy prospective kidney donors and patients with stable chronic renal impairment.
[I-123]-OIH Safety	Visit 3 and Follow-up Phone Call	Evaluate the safety of a single injection of \[I-123\]-OIH administered to a population of healthy prospective kidney donors and patients with stable chronic renal impairment.

Secondary Outcome Measures

Name	Time	Method
Image-derived Perfusion Data	Visits 2 and 3	Compare results of differential perfusion(from image-derived perfusion data) of \[I-123\]-OIH and \[Tc-99m\]-MAG3.
eRPF	Visits 2 and 3	Compare results of effective renal plasma flow (eRPF), using the single sample clearance method of \[I-123\]-OIH and \[Tc-99m\]-MAG3.
Qualitative Assessment	Visit 2 and 3	Compare the qualitative assessment of kidney uptake, urine excretion and image quality of \[I-123\]-OIH and \[Tc-99m\]-MAG3 in an independent read by two nuclear medicine physicians blinded to all participant clinical data.

Trial Locations

Locations (1)

St. Joesph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada