NCT04528758CompletedEarly phase 1
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
Source: ClinicalTrials.gov · Last updated 21 Jul 2026
Brief summary (registry, in English)
Use of novel radio-pharmaceutical Rhodamine 6G to determine myocardial blood flow
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 13 Aug 2020
- Start date
- 16 Oct 2018
- Primary completion date
- 24 Jun 2024
- Lead sponsor
- Washington University School of Medicine
- Diseases
- Coronary artery disease
- NCT number
- NCT04528758
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 15
- From 16 Oct 2018 to the primary completion date, 24 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently using recreational drugs
- 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.
Other illness
- 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.
- Has a history of hypersensitivity to Fluorine-18 or other radiopharmaceutical or any of its excipients.
- Have Epilepsy
- Have current or past history of major medical illness
Lab values
- 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.
Other
- 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).
- Have contraindications to cardiovascular PET/CT imaging such as claustrophobia.
- Have high blood pressure (\>200/110)
- Have major kidney or liver problems
- Body weight of \> 300 lbs. (weight limit of the PET/CT table)
Who the study is looking for
- 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.
Age in the registry: 21 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.