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

Determination of renal blood flow based on Rubidium-82 and PET-technology in healthy volunteers

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004080-39-DK

Enrollment

Registered

2016-10-21

Start date

2017-03-31

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

We wish to determine, whether PET-scans with Rubidium-82 can be used to determine renal blood flow MedDRA version: 20.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations

Interventions

Trade Name: Cardiogen-82 Product Name: Rubidium-82 chloride Pharmaceutical Form: Radionuclide generator INN or Proposed INN: NA CAS Number: 8000049-30-1 Other descriptive name: RUBIDIUM (82 RB) Concen

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Denmark

Contacts

Public ContactStine Langaa

Medicinsk Forskning, Regionshospitalet Holstebro, Hospitalsenheden Vest

stinlg@rm.dk004578436587

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026