Heart DiseasePhase 1NCT01433705
Distribution of Rubidium-82, Nitrogen-13 Ammonia, and Fluorine-18 Fluorodeoxyglucose in Normal Volunteers
A Phase 1 study testing Rb-82 Pet scans, F-18 FDG Pet scans and N-13 ammonia Pet scans in people with Heart Disease, run by University of Michigan at 1 site in United States.
Trial summary
Establish the normal distributions of Rb-82, N-13 ammonia, and F-18 FDG (radioactive tracers) in the heart using PET imaging. These tracers would be eventually used in evaluating the hearts of patients with heart disease. Normal healthy volunteers will be carefully screened for this study. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Disease
- What is being tested?
- Rb-82 Pet scans, F-18 FDG Pet scans and N-13 ammonia Pet scans
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to 19 Jan 2018
- Phase
- Phase 1
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy normal volunteers
Who cannot join
- Prior participation in a study with significant radiation exposure
- Significant radiation exposure for other reasons, example: routine medical care
- Medical history of physical or treadmill exercise stress EKG evidence of heart or vascular disease.
- Cardiac A-V conduction abnormalities
- Diabetes Mellitus
- Liver Disease
Show all 17Show fewer
- Kidney Disease
- Other chronic debilitating illnesses ( Example: Rheumatoid Arthritis, Emphysema, Parkinson's Disease).
- Tobacco use, hypertension, diabetes, family history of coronary artery disease before age 45 in males and 55 in females or other coronary risks factors of more than mild severity
- Claustrophobia (fear of tight spaces)
- Pregnancy
- Inability to lay flat with your arms positioned next to your head for approximately 20 minutes.
- Morbid Obesity
- Asthma
- Breasts Implants
- Use of anabolic steroids
- Use of recreational drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: Evaluation of the Normal Distribution of Rubidium-82(Rb-82), Nitrogen-13 (N-13)Ammonia, and Fluorine-18 Fluorodeoxyglucose (F-18FDG) in Normal Volunteers
Establish the normal distributions of Rb-82, N-13 ammonia, and F-18 FDG (radioactive tracers) in the heart using PET imaging. These tracers would be eventually used in evaluating the hearts of patients with heart disease.
Normal healthy volunteers will be carefully screened for this study. Subjects will be given IV administration of Rb-82 and N-13 to acquire rest/stress imaging. Normal subjects not excluded by any unexpected abnormality during the Rb-82 or N-13 rest/stress studies will undergo a glucose loading F-18 FDG imaging protocol, viability protocol using the hyperinsulinemic euglycemic clamp with simultaneous IV infusions of dextrose and insulin according to standard procedures in our laboratory.
These same subjects will have a F-18 FDG protocol after following a high fat, protein permitted, no carbohydrate diet for approximately 30 hours prior to F-18 FDG injection. The F-18 FDG radiotracer will be given through an IV.
Read the detailed description
Cardiac rubidium-82(Rb-82)and N-13 ammonia heart perfusion (blood flow) studies and florine-18 fluorodeoxyglucose (F-18FDG) heart PET glucose metabolism studies are important tools for evaluating patients with coronary heart disease.
This includes patients with known or suspected heart disease and patients with congestive heart failure following myocardial infarction (heart attack) with indeterminant assessments of cardiac health from other types of imaging, such as SPECT perfusion imaging and echocardiography.
These studies help physicians plan potentially life saving procedures to re-establish coronary blood flow to living but severely compromised heart muscle. Rb-82 and N-13 ammonia studies can tell if there is reduced blood flow to the heart muscle either at rest or during stress.
FDG studies can tell whether there is any chance of a beneficial effect from coronary revascularization procedures, for example coronary angioplasties and stents or coronary artery bypass. Revascularization procedures in patients like these may be technically difficult, risky and costly.
Unfortunately the normal cardiac distributions of Rb-82, N-13 and ammonia, and F-18FDG for computer analysis of human studies are not well known and what is known is not widely available for clinical use. The latest imaging guidelines from the American Society of Nuclear Cardiology recommend that Rb-82, N-13 ammonia, and FDG cardiac studies be compared to normal distributions or patterns of these radiotracers in the heart developed from a series of normal individuals.
The purpose for these studies is to generate databases of normal Rb-82, N-13 ammonia, and F-18FDG cardiac distributions so that they can be used in the analysis of clinical patient studies at the University of Michigan Hospital.
- Conditions
- Heart Disease
- Being tested
- Rb-82 Pet scans, F-18 FDG Pet scans, N-13 ammonia Pet scans, Regadenoson
- Keywords
- heart, perfusion, glucose
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rb-82 Pet scansOther
Intravenous administration of Rb-82. Images will be taken according to standard clinical imaging protocol and reviewed. Patient will be connected to an EKG machine to monitor the heart. Blood pressure will be monitored as well. For Rb-82 images, 40 mCi (millicuries are a measurement of radioactivity) will be used. Acquisition time for both rest and stress studies should take about 30 min.
F-18 FDG Pet scansOther
Volunteers undergoing the F-18 FDG protocols will undergo: (1) glucose loading protocol for "viability protocol imaging" with the hyperinsulinemic euglycemic clamp according to standard procedures in our laboratory, and (2) "inflammation protocol imaging" using a high fat preparatory diet and three sub-therapeutic heparin doses (10 units / kg each) according to standard laboratory procedure. When metabolically prepared with the viability protocol and the inflammation protocol (two separate days), 10 mCi (millicuries) of F-18 FDG will be administered IV per FDG protocols, via heparin lock. 40-60 minutes after FDG injections PET imaging will be performed according to standard clinical imaging protocol.
N-13 ammonia Pet scansOther
Intravenous administration of N-13. Images will be taken according to standard clinical imaging protocol and reviewed. Patient will be connected to an EKG machine to monitor the heart. Blood pressure will be monitored as well. For N-13 ammonia images, 20 mCi (millicuries) will be used. Acquisition time for both rest and stress studies should take about 30 min.
RegadenosonDrug
Regadenoson is used as a stressor; but not to study its effects.
| Study group | Role | What they receive |
|---|---|---|
| Rb-82 and N-13 ammonia Pet scans | Other | Rest and vasodilator stress Rb-82 images and N-13 ammonia images will be taken according to standard clinical imaging protocol. Each of these two imaging studies require the injection of Rb-82 and N-13 ammonia by intravenous administration (IV) in the patient's arm. Receives: Other: Rb-82 Pet scans; Other: N-13 ammonia Pet scans; Drug: Regadenoson |
| F-18 FDG Imaging and Rb-82 | Other | Volunteers not excluded by abnormal rest/stress imaging with Rb-82, will begin F-18 FDG protocol. Receives: Other: Rb-82 Pet scans; Other: F-18 FDG Pet scans; Drug: Regadenoson |
| F-18 FDG Imaging and N-13 ammonia | Other | Volunteers not excluded by abnormal rest/stress imaging with N-13 ammonia, will begin F-18 FDG protocol. Receives: Other: F-18 FDG Pet scans; Other: N-13 ammonia Pet scans; Drug: Regadenoson |
What is being measured
The primary outcome is the main question the study is designed to answer.
analysis of healthy cardiac distribution of Rb-82, N-13 ammonia, and F-18 FDG.
Normal healthy volunteers will undergo PET imaging during vasodilator pharmacologic stress with regadenoson and at rest with Rb-82 and or N-13 ammonia and or at rest with F-18FDG. Participants will have either rest and stress Rb-82 and rest and stress N-13 ammonia or one of these stress tests and F-18 FDG imaging.
Measured: approximately 4 to 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startNov 2011
- Primary completion19 Jan 2018
- Study completion19 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will have a PET scan after IV administration of a radio-labelled tracer, Rb-82 and N-13 or injection of F-18 FDG
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James R. Corbett, M.D., University of Michigan
- Investigators
- James R. Corbett, M.D., Principal investigator, University of Michigan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433705
- Sponsor's protocol ID
- HUM00016183
- Status last verified
- Jan 2019
- First submitted
- 13 Sep 2011
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Normal Distribution of Rubidium-82(Rb-82), Nitrogen-13 (N-13)Ammonia, and Fluorine-18 Fluorodeoxyglucose (F-18FDG) in Normal Volunteers
- ClinicalTrials.gov ID
- NCT01433705
- Acronym / sponsor ID
- HUM00016183
- Conditions
- Heart Disease
- Keywords
- heart, perfusion, glucose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Nov 2011 (actual)
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 19 Jan 2018 (actual)
- First posted
- 14 Sep 2011 (estimated)
- 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.
Establish the normal distributions of Rb-82, N-13 ammonia, and F-18 FDG (radioactive tracers) in the heart using PET imaging. These tracers would be eventually used in evaluating the hearts of patients with heart disease.
Normal healthy volunteers will be carefully screened for this study. Subjects will be given IV administration of Rb-82 and N-13 to acquire rest/stress imaging. Normal subjects not excluded by any unexpected abnormality during the Rb-82 or N-13 rest/stress studies will undergo a glucose loading F-18 FDG imaging protocol, viability protocol using the hyperinsulinemic euglycemic clamp with simultaneous IV infusions of dextrose and insulin according to standard procedures in our laboratory.
These same subjects will have a F-18 FDG protocol after following a high fat, protein permitted, no carbohydrate diet for approximately 30 hours prior to F-18 FDG injection. The F-18 FDG radiotracer will be given through an IV.
Detailed description
Cardiac rubidium-82(Rb-82)and N-13 ammonia heart perfusion (blood flow) studies and florine-18 fluorodeoxyglucose (F-18FDG) heart PET glucose metabolism studies are important tools for evaluating patients with coronary heart disease.
This includes patients with known or suspected heart disease and patients with congestive heart failure following myocardial infarction (heart attack) with indeterminant assessments of cardiac health from other types of imaging, such as SPECT perfusion imaging and echocardiography.
These studies help physicians plan potentially life saving procedures to re-establish coronary blood flow to living but severely compromised heart muscle. Rb-82 and N-13 ammonia studies can tell if there is reduced blood flow to the heart muscle either at rest or during stress.
FDG studies can tell whether there is any chance of a beneficial effect from coronary revascularization procedures, for example coronary angioplasties and stents or coronary artery bypass. Revascularization procedures in patients like these may be technically difficult, risky and costly.
Unfortunately the normal cardiac distributions of Rb-82, N-13 and ammonia, and F-18FDG for computer analysis of human studies are not well known and what is known is not widely available for clinical use. The latest imaging guidelines from the American Society of Nuclear Cardiology recommend that Rb-82, N-13 ammonia, and FDG cardiac studies be compared to normal distributions or patterns of these radiotracers in the heart developed from a series of normal individuals.
The purpose for these studies is to generate databases of normal Rb-82, N-13 ammonia, and F-18FDG cardiac distributions so that they can be used in the analysis of clinical patient studies at the University of Michigan Hospital.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Subjects will have a PET scan after IV administration of a radio-labelled tracer, Rb-82 and N-13 or injection of F-18 FDG
| Arm | Type | Receives |
|---|---|---|
| Rb-82 and N-13 ammonia Pet scans | Other | Other: Rb-82 Pet scans, Other: N-13 ammonia Pet scans, Drug: RegadenosonRest and vasodilator stress Rb-82 images and N-13 ammonia images will be taken according to standard clinical imaging protocol. Each of these two imaging studies require the injection of Rb-82 and N-13 ammonia by intravenous administration (IV) in the patient's arm. |
| F-18 FDG Imaging and Rb-82 | Other | Other: Rb-82 Pet scans, Other: F-18 FDG Pet scans, Drug: RegadenosonVolunteers not excluded by abnormal rest/stress imaging with Rb-82, will begin F-18 FDG protocol. |
| F-18 FDG Imaging and N-13 ammonia | Other | Other: F-18 FDG Pet scans, Other: N-13 ammonia Pet scans, Drug: RegadenosonVolunteers not excluded by abnormal rest/stress imaging with N-13 ammonia, will begin F-18 FDG protocol. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy normal volunteers
Key exclusion criteria (17 listed)
- Prior participation in a study with significant radiation exposure
- Significant radiation exposure for other reasons, example: routine medical care
- Medical history of physical or treadmill exercise stress EKG evidence of heart or vascular disease.
- Cardiac A-V conduction abnormalities
- Diabetes Mellitus
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 |
|---|---|---|
| Rb-82 Pet scansIntravenous administration of Rb-82. Images will be taken according to standard clinical imaging protocol and reviewed. Patient will be connected to an EKG machine to monitor the heart. Blood pressure will be monitored as well. For Rb-82 images, 40 mCi (millicuries are a measurement of radioactivity) will be used. Acquisition time for both rest and stress studies should take about 30 min. | Other | F-18 FDG Imaging and Rb-82, Rb-82 and N-13 ammonia Pet scans |
| F-18 FDG Pet scansVolunteers undergoing the F-18 FDG protocols will undergo: (1) glucose loading protocol for "viability protocol imaging" with the hyperinsulinemic euglycemic clamp according to standard procedures in our laboratory, and (2) "inflammation protocol imaging" using a high fat preparatory diet and three sub-therapeutic heparin doses (10 units / kg each) according to standard laboratory procedure. When metabolically prepared with the viability protocol and the inflammation protocol (two separate days), 10 mCi (millicuries) of F-18 FDG will be administered IV per FDG protocols, via heparin lock. 40-60 minutes after FDG injections PET imaging will be performed according to standard clinical imaging protocol. | Other | F-18 FDG Imaging and N-13 ammonia, F-18 FDG Imaging and Rb-82 |
| N-13 ammonia Pet scansIntravenous administration of N-13. Images will be taken according to standard clinical imaging protocol and reviewed. Patient will be connected to an EKG machine to monitor the heart. Blood pressure will be monitored as well. For N-13 ammonia images, 20 mCi (millicuries) will be used. Acquisition time for both rest and stress studies should take about 30 min. | Other | F-18 FDG Imaging and N-13 ammonia, Rb-82 and N-13 ammonia Pet scans |
| RegadenosonRegadenoson is used as a stressor; but not to study its effects. | Drug | F-18 FDG Imaging and N-13 ammonia, F-18 FDG Imaging and Rb-82, Rb-82 and N-13 ammonia Pet scans |
Primary outcome
analysis of healthy cardiac distribution of Rb-82, N-13 ammonia, and F-18 FDG.
Time frame: approximately 4 to 10 hours
Normal healthy volunteers will undergo PET imaging during vasodilator pharmacologic stress with regadenoson and at rest with Rb-82 and or N-13 ammonia and or at rest with F-18FDG. Participants will have either rest and stress Rb-82 and rest and stress N-13 ammonia or one of these stress tests and F-18 FDG imaging.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Heart Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
James R. Corbett, M.D. principal investigator
University of Michigan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rb-82 Pet scans, F-18 FDG Pet scans and N-13 ammonia Pet scans in people with Heart Disease, run by University of Michigan at 1 site in United States.
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 17 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: finished, as of the sponsor's last update on 30 Jan 2019. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analysis of healthy cardiac distribution of Rb-82, N-13 ammonia, and F-18 FDG. (time frame: approximately 4 to 10 hours). 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 30 Jan 2019.