Test of reliability of PET-scan and the radioactive isotope rubidium-82 in determination of blood flow in the kidneys in healthy subjects
Phase 1
- Conditions
- We wish to test the reliability of PET-rubium-82-scans in regards to determination of renal blood flowMedDRA version: 20.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - InvestigationsTherapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
- Registration Number
- EUCTR2017-005008-88-DK
- Lead Sponsor
- Medicinsk Forskning, Regionshospitalet Holstebro, Hospitalsenheden Vest
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
50-80 years, BMI 18,5-30 kg/m2, fertile women must use contraception, signed consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria
Medical treatment except contraception, alcohol abuse, sustance abuse, cancer, tobacco smoking, clinically significant signs of heart, lung-, liver, - kidney-, metabolic or neurologic disorders, clinically significant abnormalities in blood tests, urine tests or ECG, high blood pressure
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To test the reliability PET-rubium-82-scans in regards to determination of renal blood flow;Timepoint(s) of evaluation of this end point: At the end of the trial when all subjects have completed the examination days;Secondary Objective: Not applicable;<br> Primary end point(s): Renal blood flow<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Inter-assay variationcoefficient;Timepoint(s) of evaluation of this end point: At the end of the trial when all subjects have completed the examinationdays