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

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.

Study Overview

• Status: Completed
• Conditions: Renal Function Impairment

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 Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants will be recruited from both healthy subjects (eGFR ≥ 60 mL/minute/1.73m^2) being assessed as potential renal donors and patients having suspected renal impairment (eGFR <60 mL/minute/1.73m^2). Severity of disease will be determined based on estimated glomerular filtration rate (eGFR) derived from serum creatinine concentration.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Healthy Participants; eGFR ≥60 ml/min/1.73m^2, healthy prospective kidney donor
Moderate Renal Function Impairment; eGFR 30-59 ml/minute/1.73m^2
Severe Renal Function Impairment; eGFR <30 mL/minute/1.73m^2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
[I-123]-OIH Safety	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.	Visit 3 and Follow-up Phone Call
Compare kidney function using [I-123]-OIH and [Tc-99m]-MAG3 imaging	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.	Visit 2 and 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative Assessment	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.	Visit 2 and 3
Image-derived Perfusion Data	Compare results of differential perfusion(from image-derived perfusion data) of [I-123]-OIH and [Tc-99m]-MAG3.	Visits 2 and 3
eRPF	Compare results of effective renal plasma flow (eRPF), using the single sample clearance method of [I-123]-OIH and [Tc-99m]-MAG3.	Visits 2 and 3

Collaborators and Investigators

• Sponsor: Centre for Probe Development and Commercialization
• Collaborators: St. Joseph's Healthcare Hamilton; McMaster University
• Investigators: Principal Investigator: Karen Gulenchyn, MD, St. Joseph's Healthcare Hamilton

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: December 18, 2011
• First Submitted That Met QC Criteria: December 20, 2011
• First Posted (Estimate): December 21, 2011

Study Record Updates

• Last Update Posted (Estimate): April 9, 2014
• Last Update Submitted That Met QC Criteria: April 8, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: imaging; renal function; I-123 OIH; Tc-99m MAG 3
• Other Study ID Numbers: CPDC-HIPP-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No