- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04528758
F-18 Rhodamine 6G PET Imaging for Myocardial Blood Flow
Preliminary Evaluation of F-18 Rhodamine 6G in Healthy Individuals and Patients With Stable Heart Condition
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female, 21-75 years of age and any race.
- Capable of giving written informed consent.
- "Healthy adult volunteer subject" is someone who is volunteering to undergo imaging procedures and based on screening procedures has no known significant health problems.
- Stable patients with known or suspected coronary artery disease that are scheduled to have or have undergone a clinically indicated conventional rest/stress SPECT MPI and no intervention between SPECT and PET.
- Female subjects must not be pregnant or lactating.
Exclusion Criteria:
- Has any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the subject, limit the subject's ability to tolerate the research procedures, or interfere with collection of the data.
- Have abnormal findings on any screening/baseline procedure, e.g. physical examination, laboratory tests, electrocardiogram that suggest the subject might have a condition that could, in the opinion of the Sponsor-Investigator, affect the subject's response to the radiopharmaceutical or related research procedures.
- Is deemed likely to be unable to perform all research procedures for any reason, (e.g., subjects unable to lie still or inability to tolerate up to 60 minutes in a supine position with arms up during the PET imaging procedures due to chronic back/shoulder pain or arthritis as assessed by physical examination and medical history).
- Has a history of hypersensitivity to Fluorine-18 or other radiopharmaceutical or any of its excipients.
- Have contraindications to cardiovascular PET/CT imaging such as claustrophobia.
- Have high blood pressure (>200/110)
- Have Epilepsy
- Have major kidney or liver problems
- Have current or past history of major medical illness
- Currently using recreational drugs
- Body weight of > 300 lbs. (weight limit of the PET/CT table)
Stable Cardiac Disease: Rest/Stress Group only:
- Cardiac patients who suffer an intervening clinical event such as worsening angina pectoris or myocardial infarction or whom undergo a myocardial revascularization procedure or have myocardial ischemia at rest.
- Sinus node disease (e.g. SA block) or symptomatic bradycardia, second or third degree atrioventricular (AV) block.
- Pre-existing obstructive lung disease (e.g. asthma) that precludes the safe administration of the pharmacological stressor according to the approved label.
- Uncontrolled and severe hypertension (e.g. systolic blood pressure >200 mmHg, diastolic blood pressure >110 mmHg).
- Baseline hypotension (e.g. systolic blood pressure < 90 mmHg, diastolic blood pressure <50 mmHg).
- Seizures
- The use of caffeine, nicotine or over the counter cold medicines within 12 hours prior to stress imaging day with regadenoson.
- The theophylline-based medications or dipyridamole within 48 hours prior to each imaging day.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dosimetry group
Patients in the dosimetry group will be imaged with the radio-pharmaceutical Rhodamine 6G at different time points.
0-120, 30-150, 60-180
|
Rhodamine 6G radio-pharmaceutical will be injected to determine myocardial blood flow
Other Names:
|
Active Comparator: Stable Heart Patients
Stable heart patients will be given a rest/stress PET/CT with Rhodamine 6G myocardial perfusion study to determine myocardial blood flow
|
Rhodamine 6G radio-pharmaceutical will be injected to determine myocardial blood flow
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dosimetry group
Time Frame: 1-2 days
|
Evaluate both image quality and myocardial blood flow at different imaging time points. Image quality provides higher count Density and high spatial resolution, which makes it easier to see the heart vessels, and myocardial blood flow is measured in mL/g/min. Both measurements will be agregated to arrive at one reported value helps determine the balance of heart disease and in small and large vessels |
1-2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stable Heart Patients
Time Frame: 1-2 days
|
Determine myocardial blood flow in stable heart patients.
Myocardial blood flow is measured in mL/g/min which can show normal blood flow with stable patients.
|
1-2 days
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201808025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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