Test of reliability of PET-scan and the radioactive isotope rubidium-82 in determination of blood flow in the kidneys in healthy subjects

Test of reliability of PET-rubidium82-scan in determination of renal blood flow in healthy subjects

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-005008-88-DK

Enrollment

Registered

2018-01-18

Start date

2018-05-09

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

We wish to test the reliability of PET-rubium-82-scans in regards to determination of 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 Numb

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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; Primary end point(s): Renal blood flow	—

Secondary

Measure	Time frame
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	—

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