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

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

Study Overview

• Status: Suspended
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Rhodamine 6G

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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)

Number of Arms

2

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	Drug: Rhodamine 6G; Rhodamine 6G radio-pharmaceutical will be injected to determine myocardial blood flow; Other Names: PET/positron Emission Tomography imaging
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	Drug: Rhodamine 6G; Rhodamine 6G radio-pharmaceutical will be injected to determine myocardial blood flow; Other Names: PET/positron Emission Tomography imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2018
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Antineoplastic Agents; Rhodamine 6G
• Other Study ID Numbers: 201808025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No