New radioactive dye could sharpen heart scans

NCT ID NCT04528758

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This early study tests a new radioactive dye, F-18 rhodamine 6G, to see if it can produce clearer PET scans of the heart. The dye is injected and then images are taken to measure blood flow in the heart muscle. The trial includes both healthy volunteers and people with stable coronary artery disease. The goal is to evaluate image quality and whether the dye can accurately show blood flow in small and large heart vessels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a radioactive form of rhodamine 6G called F-18 rhodamine 6G, used as a PET imaging dye
What this could lead to
If successful, this imaging method could provide clearer, more detailed heart scans to help doctors assess coronary artery disease and blood flow in both small and large heart vessels.
What could go wrong
This is a very early, small study (15 people) focused on image quality and safety, not on treating disease. The dye may not prove better than existing methods, and its use is limited to imaging, not therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

15 people

The number who actually took part.

Started

Oct 2018

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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