F-18 Rhodamine 6G PET Imaging for Myocardial Blood Flow

Coronary Artery Disease Clinical Trial

Official title:

Preliminary Evaluation of F-18 Rhodamine 6G in Healthy Individuals and Patients With Stable Heart Condition

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04528758
• Other study ID #: 201808025
• Status: Suspended
• Phase: Early Phase 1
• Start date: October 16, 2018
• Est. completion date: December 2024

Study information

• Verified date: August 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Use of novel radio-pharmaceutical Rhodamine 6G to determine myocardial blood flow

Description:

Using Rhodamine 6G to determine myocardial blood flow in normal volunteers and patients with coronary heart disease.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 15
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Drug:
• Rhodamine 6G
Rhodamine 6G radio-pharmaceutical will be injected to determine myocardial blood flow

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1-2 days
Secondary	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.	1-2 days