Determination of blood flow in the kidneys based on PET-scans and Rubidium-82 as radioactive isotope in healthy humans

Phase 1

• Conditions: We wish to determine, whether PET-scans with Rubidium-82 can be used to determine renal blood flow; MedDRA version: 20.0Level: SOCClassification code 10022891Term: InvestigationsSystem Organ Class: 10022891 - Investigations; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2016-004080-39-DK
• Lead Sponsor: Medicinsk Forskning, Regionshospitalet Holstebro, Hospitalsenheden Vest

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-21
• Study Completion: 2018-05-28
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Age 18-40 years, BMI 18,5-30 kg/m2, women must use contraception
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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Medical treatment in the last 2 weeks except for contraception, pregnancy or nursing, consumption of more than 14 units of alcohol for men and more than 7 for women per week, tobacco smoking, neoplasm, clinically significant heart, lung, liver, kidney, metanolic or neurologic disorders, clinically significant findings in blood samples, urine sample or ECG, office blood pressure > 140/90mmHg, substance abuse

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To develop a new and reliable method to determine renal blood flow based on Rubidium-82 and PET-technology using a 1-tissue compartment model;Secondary Objective: Not applicable;Primary end point(s): Renal blood flow ;Timepoint(s) of evaluation of this end point: At the end of the trial when all subjects have completed the day of examination

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Intra-assay variationcoefficient;Timepoint(s) of evaluation of this end point: At the end of the trial when all subjects have completed the day of examination