Coronary Artery DiseaseEarly Phase 1NCT04528758
F-18 Rhodamine 6G PET Imaging for Myocardial Blood Flow
A Early Phase 1 study testing Rhodamine 6G in people with Coronary Artery Disease, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Use of novel radio-pharmaceutical Rhodamine 6G to determine myocardial blood flow Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Rhodamine 6G
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2018to 20 Dec 2024
- Phase
- Early 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Preliminary Evaluation of F-18 Rhodamine 6G in Healthy Individuals and Patients With Stable Heart Condition
Use of novel radio-pharmaceutical Rhodamine 6G to determine myocardial blood flow
Read the detailed description
Using Rhodamine 6G to determine myocardial blood flow in normal volunteers and patients with coronary heart disease.
- Conditions
- Coronary Artery Disease
- Being tested
- Rhodamine 6G
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhodamine 6GDrug
Also called PET/positron Emission Tomography imaging
Rhodamine 6G radio-pharmaceutical will be injected to determine myocardial blood flow
| Study group | Role | What they receive |
|---|---|---|
| Dosimetry group | Experimental | Patients in the dosimetry group will be imaged with the radio-pharmaceutical Rhodamine 6G at different time points. 0-120, 30-150, 60-180 Receives: Drug: Rhodamine 6G |
| Stable Heart Patients | Active comparator | Stable heart patients will be given a rest/stress PET/CT with Rhodamine 6G myocardial perfusion study to determine myocardial blood flow Receives: Drug: Rhodamine 6G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosimetry group
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
Measured: 1-2 days
Secondary outcomes (1)
Stable Heart Patients
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.
Measured: 1-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start16 Oct 2018
- Primary completion24 Jun 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Robert Gropler, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528758
- Sponsor's protocol ID
- 201808025
- Status last verified
- Jul 2026
- First submitted
- 13 Aug 2020
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Evaluation of F-18 Rhodamine 6G in Healthy Individuals and Patients With Stable Heart Condition
- ClinicalTrials.gov ID
- NCT04528758
- Acronym / sponsor ID
- 201808025
- Conditions
- Coronary Artery Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Boston Children's Hospital
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 27 Aug 2020 (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.
Use of novel radio-pharmaceutical Rhodamine 6G to determine myocardial blood flow
Detailed description
Using Rhodamine 6G to determine myocardial blood flow in normal volunteers and patients with coronary heart disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dosimetry group | Experimental | Drug: Rhodamine 6GPatients in the dosimetry group will be imaged with the radio-pharmaceutical Rhodamine 6G at different time points. 0-120, 30-150, 60-180 |
| Stable Heart Patients | Active comparator | Drug: Rhodamine 6GStable heart patients will be given a rest/stress PET/CT with Rhodamine 6G myocardial perfusion study to determine myocardial blood flow |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
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 |
|---|---|---|
| Rhodamine 6GAlso: PET/positron Emission Tomography imagingRhodamine 6G radio-pharmaceutical will be injected to determine myocardial blood flow | Drug | Dosimetry group, Stable Heart Patients |
Primary outcome
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 secondary outcome
Stable Heart Patients
Time frame: 1-2 days
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 21 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Robert Gropler, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rhodamine 6G in people with Coronary Artery Disease, run by Washington University School of Medicine 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 5 inclusion and 20 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 21 Jul 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Dosimetry group (time frame: 1-2 days). 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 21 Jul 2026.