Clinical trial NCT01496391: A Single Centre Open Label Comparison of [I-123]-Ortho-Iodohippuric Acid (OIH) With [Tc-99m]-Mercaptoacetyltriglycine (MAG3) for Assessment of Renal Tubular Function
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Function Impairment
Keywords: imaging
renal function
I-123 OIH
Tc-99m MAG 3
Lead sponsor: Centre for Probe Development and Commercialization
Sponsor class: OTHER
Collaborators: name: McMaster University
name: St. Joseph's Healthcare Hamilton
First posted: 2011-12-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: [I-123]-OIH Safety
timeFrame: Visit 3 and Follow-up Phone Call
measure: Compare kidney function using [I-123]-OIH and [Tc-99m]-MAG3 imaging
timeFrame: Visit 2 and 3
Secondary outcomes:
measure: Qualitative Assessment
timeFrame: Visit 2 and 3
measure: Image-derived Perfusion Data
timeFrame: Visits 2 and 3
measure: eRPF
timeFrame: Visits 2 and 3
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joesph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Karen Gulenchyn, MD
role: PRINCIPAL_INVESTIGATOR
References: