KidneysNCT06555211
Cardio and Renovascular Effects of Isometric Exercise in the Healthy Human Measured by PET/CT and MRI
A study testing MRI and PET/CT in people with Kidneys, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
This randomized crossover study aims to validate measurements of renal perfusion in healthy males with PET/CT, using 15-oxygen labeled water as tracer, against the validated multiparametric MRI technique. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Kidneys
- What is being tested?
- MRI and PET/CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 7 May 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal health stated through medical questionnaire, examination and blood samples.
Who cannot join
- Immunosuppressive treatment
- Alcohol abuse
- Treatment with glucocorticoids, Glucagon-like peptide-1 (GLP-1) agonists, dipeptidyl peptidase 4 (DPP-4)-inhibitors
- Medical treatment affecting insulin secretion or cardiovascular endpoints
- Liver disease
- Decreased kidney function
- Severe claustrophobia
- Elements incompatible with MR.
Trial locations and contacts
1 site in 1 country.
Ali Asmar, MD, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Bispebjerg Hospital, Department of Clinical Physiology & Nuclear Medicine
Copenhagen, Capital Region, 2400
Peter Sørensen, MD, +4530516279, peter.soerensen@regionh.dk
Ali Asmar, MD, PhD, ali.asmar@regionh.dk
About this study
Official title: Cardio and Renovascular Effects of Static Muscle Work in the Healthy Human - Measured With Finapres® and Positron Emission Tomography (PET) Using 15-oxygen Labeled Water as Tracer Compared to Magnetic Resonance (MR)
This randomized crossover study aims to validate measurements of renal perfusion in healthy males with PET/CT, using 15-oxygen labeled water as tracer, against the validated multiparametric MRI technique.
The study will determine:
- Total renal blood flow and regional renal perfusion at baseline (rest) and during isometric muscle exercise of the upper arm, using PET/CT (with 15-oxygen labeled water as a tracer) and MRI.
- The coefficient of variation of renal blood flow and regional renal perfusion measurements at baseline and during isometric muscle exercise of the upper arm, using PET/CT (with 15-oxygen labeled water as a tracer) and MRI.
- Regional renal oxygenation and oxygen extraction at baseline and during isometric muscle exercise of the upper arm using MRI.
- The coefficient of variation on regional renal oxygenation and oxygen extraction measurements at baseline and during isometric muscle exercise of the upper arm using MRI.
Read the detailed description
Measuring tissue perfusion with PET/CT using 15-oxygen labeled water is routinely used as a non-invasive tool to examine cerebral and myocardial perfusion. With a 100% tissue extraction, 15-oxygen labeled water is gold standard.
The aim of the present study is to validate renal perfusion measurements with PET/CT using 15-oxygen labeled water as tracer against the validated multiparametric MRI technique.
Once validated the imaging technique will be beneficial in examining vascular damage in the kidneys caused by different renal diseases.
This is a randomized, crossover study where each participant will participate in 1 study day.
Ten healthy male participants in the age group 20-60 years are screened and randomized, and expected to complete the present study. Informed consent is obtained before the screening meeting.
All participants consume a controlled diet with fixed salt intake corresponding to a daily intake of 50-70 mmol + 2 mmol/kg sodium for 4 days before the experiment. On the fourth day, 24-hour urine collection will be performed. Throughout the 4 day period, water intake will be ad libitum and physical activity will not be allowed.
Each participant will undergo both PET/CT and MRI separated by around 1.5 hour.
Total renal blood flow and regional renal perfusion are measured repeatedly altogether 5 times with both PET/CT and MRI. Renal oxygenation and oxygen extraction are measured repeatedly 5 times as well, using MRI. The 5 measurements consist of 2 at baseline (rest), 2 during isometric exercise (handgrip) and 1 during recovery (rest).
Isometric muscle exercise is conducted by squeezing a handgrip coupled to a dynamometer. This increases sympathetic nervous activity, leading to preglomerular vasoconstriction.
- Conditions
- Kidneys
- Being tested
- MRI, PET/CT
- Keywords
- Total renal blood flow, Regional renal perfusion, Regional renal oxygenation, Renal oxygen extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
MRI will be performed
PET/CTProcedure or surgery
PET/CT will be performed
| Study group | Role | What they receive |
|---|---|---|
| Group randomized to begin with MRI | Other | Group is randomized to begin with MRI and have PET/CT performed later on the same day Receives: Procedure: MRI; Procedure: PET/CT |
| Group randomized to begin with PET/CT | Other | Group is randomized to begin with PET/CT and have MRI performed later on the same day Receives: Procedure: MRI; Procedure: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of variation on total blood flow and regional renal perfusion measurements at rest and during isometric muscle exercise, measured by PET/CT with 15-Oxygen labeled water and MRI
No metric unit
Measured: Each participant's study day during the span of the study (approximately 5 months)
Total blood flow at rest and during isometric muscle exercise measured by PET/CT with 15-Oxygen labeled water and MRI
Volume of blood pr unit time, ml/min
Measured: Each participant's study day during the span of the study (approximately 5 months)
Regional renal perfusion at rest and during isometric muscle exercise measured by PET/CT with 15-Oxygen labeled water and MRI
Volume of blood pr unit time pr unit tissue mass, ml/min/g
Measured: Each participant's study day during the span of the study (approximately 5 months)
Regional renal oxygenation at rest and during isometric muscle exercise using MRI
Percentage, fraction
Measured: Each participant's study day during the span of the study (approximately 5 months)
Regional renal extraction of oxygen at rest and during isometric muscle exercise using MRI
Percentage, fraction
Measured: Each participant's study day during the span of the study (approximately 5 months)
Coefficient of variation on regional renal oxygenation and extraction of oxygen measurements at rest and isometric muscle exercise using MRI
No metric unit
Measured: Each participant's study day during the span of the study (approximately 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start7 May 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KidneysStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will undergo intervention, which is PET/CT, and control, which is MRI. Each participant will have both intervention and control performed the same day in randomized order.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Asmar, Bispebjerg Hospital
- Investigators
- Ali Asmar, MD, PhD, Principal investigator, Bispebjerg Hospital, Department of Clinical Physiology and Nuclear Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555211
- Sponsor's protocol ID
- H-23037460
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardio and Renovascular Effects of Static Muscle Work in the Healthy Human - Measured With Finapres® and Positron Emission Tomography (PET) Using 15-oxygen Labeled Water as Tracer Compared to Magnetic Resonance (MR)
- ClinicalTrials.gov ID
- NCT06555211
- Acronym / sponsor ID
- H-23037460
- Conditions
- Kidneys
- Keywords
- Total renal blood flow, Regional renal perfusion, Regional renal oxygenation, Renal oxygen extraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized crossover study aims to validate measurements of renal perfusion in healthy males with PET/CT, using 15-oxygen labeled water as tracer, against the validated multiparametric MRI technique.
The study will determine:
- Total renal blood flow and regional renal perfusion at baseline (rest) and during isometric muscle exercise of the upper arm, using PET/CT (with 15-oxygen labeled water as a tracer) and MRI.
- The coefficient of variation of renal blood flow and regional renal perfusion measurements at baseline and during isometric muscle exercise of the upper arm, using PET/CT (with 15-oxygen labeled water as a tracer) and MRI.
- Regional renal oxygenation and oxygen extraction at baseline and during isometric muscle exercise of the upper arm using MRI.
- The coefficient of variation on regional renal oxygenation and oxygen extraction measurements at baseline and during isometric muscle exercise of the upper arm using MRI.
Detailed description
Measuring tissue perfusion with PET/CT using 15-oxygen labeled water is routinely used as a non-invasive tool to examine cerebral and myocardial perfusion. With a 100% tissue extraction, 15-oxygen labeled water is gold standard.
The aim of the present study is to validate renal perfusion measurements with PET/CT using 15-oxygen labeled water as tracer against the validated multiparametric MRI technique.
Once validated the imaging technique will be beneficial in examining vascular damage in the kidneys caused by different renal diseases.
This is a randomized, crossover study where each participant will participate in 1 study day.
Ten healthy male participants in the age group 20-60 years are screened and randomized, and expected to complete the present study. Informed consent is obtained before the screening meeting.
All participants consume a controlled diet with fixed salt intake corresponding to a daily intake of 50-70 mmol + 2 mmol/kg sodium for 4 days before the experiment. On the fourth day, 24-hour urine collection will be performed. Throughout the 4 day period, water intake will be ad libitum and physical activity will not be allowed.
Each participant will undergo both PET/CT and MRI separated by around 1.5 hour.
Total renal blood flow and regional renal perfusion are measured repeatedly altogether 5 times with both PET/CT and MRI. Renal oxygenation and oxygen extraction are measured repeatedly 5 times as well, using MRI. The 5 measurements consist of 2 at baseline (rest), 2 during isometric exercise (handgrip) and 1 during recovery (rest).
Isometric muscle exercise is conducted by squeezing a handgrip coupled to a dynamometer. This increases sympathetic nervous activity, leading to preglomerular vasoconstriction.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participant will undergo intervention, which is PET/CT, and control, which is MRI. Each participant will have both intervention and control performed the same day in randomized order.
| Arm | Type | Receives |
|---|---|---|
| Group randomized to begin with MRI | Other | Procedure: MRI, Procedure: PET/CTGroup is randomized to begin with MRI and have PET/CT performed later on the same day |
| Group randomized to begin with PET/CT | Other | Procedure: MRI, Procedure: PET/CTGroup is randomized to begin with PET/CT and have MRI performed later on the same day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal health stated through medical questionnaire, examination and blood samples.
Key exclusion criteria (8 listed)
- Immunosuppressive treatment
- Alcohol abuse
- Treatment with glucocorticoids, Glucagon-like peptide-1 (GLP-1) agonists, dipeptidyl peptidase 4 (DPP-4)-inhibitors
- Medical treatment affecting insulin secretion or cardiovascular endpoints
- Liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI will be performed | Procedure or surgery | Group randomized to begin with MRI, Group randomized to begin with PET/CT |
| PET/CTPET/CT will be performed | Procedure or surgery | Group randomized to begin with MRI, Group randomized to begin with PET/CT |
Primary outcome
Coefficient of variation on total blood flow and regional renal perfusion measurements at rest and during isometric muscle exercise, measured by PET/CT with 15-Oxygen labeled water and MRI
Time frame: Each participant's study day during the span of the study (approximately 5 months)
No metric unit
Total blood flow at rest and during isometric muscle exercise measured by PET/CT with 15-Oxygen labeled water and MRI
Time frame: Each participant's study day during the span of the study (approximately 5 months)
Volume of blood pr unit time, ml/min
Regional renal perfusion at rest and during isometric muscle exercise measured by PET/CT with 15-Oxygen labeled water and MRI
Time frame: Each participant's study day during the span of the study (approximately 5 months)
Volume of blood pr unit time pr unit tissue mass, ml/min/g
Regional renal oxygenation at rest and during isometric muscle exercise using MRI
Time frame: Each participant's study day during the span of the study (approximately 5 months)
Percentage, fraction
Regional renal extraction of oxygen at rest and during isometric muscle exercise using MRI
Time frame: Each participant's study day during the span of the study (approximately 5 months)
Percentage, fraction
Coefficient of variation on regional renal oxygenation and extraction of oxygen measurements at rest and isometric muscle exercise using MRI
Time frame: Each participant's study day during the span of the study (approximately 5 months)
No metric unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Asmar, MD, PhD contact
Ali Asmar, MD, PhD principal investigator
Bispebjerg Hospital, Department of Clinical Physiology and Nuclear Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and PET/CT in people with Kidneys, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Sørensen, MD (+4530516279, peter.soerensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coefficient of variation on total blood flow and regional renal perfusion measurements at rest and during isometric muscle exercise, measured by PET/CT with 15-Oxygen labeled water and MRI (time frame: Each participant's study day during the span of the study (approximately 5 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.