Clinical trial NCT04528758: F-18 Rhodamine 6G PET Imaging for Myocardial Blood Flow
Official title: Preliminary Evaluation of F-18 Rhodamine 6G in Healthy Individuals and Patients With Stable Heart Condition
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: EARLY_PHASE1
Conditions: Coronary Artery Disease
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
First posted: 2020-08-27
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Dosimetry group
timeFrame: 1-2 days
Secondary outcomes:
measure: Stable Heart Patients
timeFrame: 1-2 days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Robert Gropler, MD
role: PRINCIPAL_INVESTIGATOR
References: