Renal Function Impairment Clinical Trial
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
| Verified date | April 2014 |
| Source | Centre for Probe Development and Commercialization |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 6 |
| Est. completion date | April 2014 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Canada | St. Joesph's Healthcare Hamilton | Hamilton | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Centre for Probe Development and Commercialization | McMaster University, St. Joseph's Healthcare Hamilton |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | [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 | Yes |
| Primary | 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 | Yes |
| Secondary | 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 | No |
| Secondary | 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 | Yes |
| Secondary | 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 | Yes |