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

NCT ID: NCT04528758

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-16
• Study Completion Date: 2024-12-31

Brief Summary

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Rhodamine 6G

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Rhodamine 6G

Intervention Type: DRUG

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

Interventions

Rhodamine 6G

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

Intervention Type: DRUG

Other Intervention Names

PET/positron Emission Tomography imaging

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Gropler, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

201808025

Identifier Type: -

Identifier Source: org_study_id