A Single Centre Open Label Comparison of [I-123]-Ortho-Iodohippuric Acid (OIH) With [Tc-99m]-Mercaptoacetyltriglycine (MAG3) for Assessment of Renal Tubular Function
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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 |
- [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.
- 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)
| Estimated Enrollment: | 90 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | September 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 |
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.
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| Contact: Angela Besanger | 905-525-9140 ext 21357 | abesanger@imagingprobes.ca |
| Canada, Ontario | |
| St. Joesph's Healthcare Hamilton | Recruiting |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| Contact: Bharti Gandhi 905-522-1155 ext 32953 bgandhi@stjosham.on.ca | |
| Contact: Tammy Murray (Back-up) 905-522-1155 ext 35019 tmurray@stjosham.on.ca | |
| Principal Investigator: Karen Gulenchyn, MD | |
| Sub-Investigator: William Wong-Pack, MD | |
| Sub-Investigator: Amit Singnurkar, MD | |
| 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: | February 19, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Centre for Probe Development and Commercialization:
|
imaging renal function I-123 OIH Tc-99m MAG 3 |
ClinicalTrials.gov processed this record on May 16, 2013