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

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ClinicalTrials.gov Identifier: NCT04528758
Recruitment Status : Suspended (re-evaluation of radiotracer)
First Posted : August 27, 2020
Last Update Posted : July 21, 2021
Sponsor:
Collaborator:
Boston Children's Hospital
Information provided by (Responsible Party):
Washington University School of Medicine

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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Rhodamine 6G Early Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Preliminary Evaluation of F-18 Rhodamine 6G in Healthy Individuals and Patients With Stable Heart Condition
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024

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 Name: 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 Name: PET/positron Emission Tomography imaging




Primary Outcome Measures :
  1. Dosimetry group [ Time Frame: 1-2 days ]

    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



Secondary Outcome Measures :
  1. Stable Heart Patients [ Time Frame: 1-2 days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04528758


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Boston Children's Hospital
Investigators
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Principal Investigator: Robert Gropler, MD Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04528758    
Other Study ID Numbers: 201808025
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Rhodamine 6G
Antineoplastic Agents