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

This study has been completed.
Sponsor:
Collaborators:
McMaster University
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
Centre for Probe Development and Commercialization
ClinicalTrials.gov Identifier:
NCT01496391
First received: December 18, 2011
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition
Renal Function Impairment

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Further study details as provided by Centre for Probe Development and Commercialization:

Primary Outcome Measures:
  • [I-123]-OIH Safety [ Time Frame: Visit 3 and Follow-up Phone Call ] [ Designated as safety issue: Yes ]
    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.

  • Compare kidney function using [I-123]-OIH and [Tc-99m]-MAG3 imaging [ Time Frame: Visit 2 and 3 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Qualitative Assessment [ Time Frame: Visit 2 and 3 ] [ Designated as safety issue: No ]
    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.

  • Image-derived Perfusion Data [ Time Frame: Visits 2 and 3 ] [ Designated as safety issue: Yes ]
    Compare results of differential perfusion(from image-derived perfusion data) of [I-123]-OIH and [Tc-99m]-MAG3.

  • eRPF [ Time Frame: Visits 2 and 3 ] [ Designated as safety issue: Yes ]
    Compare results of effective renal plasma flow (eRPF), using the single sample clearance method of [I-123]-OIH and [Tc-99m]-MAG3.


Biospecimen Retention:   None Retained

Whole blood (chemistry, hematology) and kidney function (eGRF, eRPF)


Enrollment: 6
Study Start Date: September 2012
Study Completion Date: April 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496391

Locations
Canada, Ontario
St. Joesph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Centre for Probe Development and Commercialization
McMaster University
St. Joseph's Healthcare Hamilton
Investigators
Principal Investigator: Karen Gulenchyn, MD St. Joseph's Healthcare Hamilton
  More Information

No publications provided

Responsible Party: Centre for Probe Development and Commercialization
ClinicalTrials.gov Identifier: NCT01496391     History of Changes
Other Study ID Numbers: CPDC-HIPP-001
Study First Received: December 18, 2011
Last Updated: April 8, 2014
Health Authority: Canada: Health Canada

Keywords provided by Centre for Probe Development and Commercialization:
imaging
renal function
I-123 OIH
Tc-99m MAG 3

Additional relevant MeSH terms:
Iodohippuric Acid
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2014