COMPLETED

Myocardial Perfusion Imaging Galmydar Rest/Stress

Conditions

Coronary Artery Disease Myocardial Perfusion imaging Pharmacological Stress Positron Emission Tomography Myocardial Blood Flow

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A single center, phase 0/1 clinical imaging study designed to assess the role of \[68Ga\]Galmydar PET/CT imaging in human subjects.

Official Title

Development and Translation of Generator-Produced PET Tracer for Myocardial Perfusion Imaging

Quick Facts

Study Start:2022-11-11

Study Completion:2025-12-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05625490

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Male and female, 18-99 years of age and any race; * Have had a prior clinical SPECT or PET MPI positive for ischemia in two myocardial segments and referred for invasive coronary angiography (ICA) or have had a prior clinical SPECT or PET MPI negative for ischemia or healthy adult normal volunteers who are asymptomatic, without history of cardiovascular disease or significant cardiovascular risk factors;	* Inability to receive and sign informed consent; * Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 6-months prior to clinical SPECT or PET or in the intervening days between clinical SPECT or PET and research PET examination; * Participants who have received chemotherapeutic agents within 6 months of enrollment; * Heart failure (left ventricular ejection fraction ≤ 20%); * Known non-ischemic cardiomyopathy; * Inability to undergo pharmacologic stress testing with regadenoson (Lexiscan). Contraindications include: * Symptomatic bradycardia or second to third degree atrioventricular (AV) block; * Pre-existing obstructive lung disease with active wheezing, i.e., COPD, asthma with active wheezing that precludes the safe administration of the pharmacological stress agent 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); * Women who are pregnant or breastfeeding; * Severe claustrophobia; * Weight ≥ 500 lbs (weight limit of PET/CT table); * Administration of any diagnostic or therapeutic radiopharmaceutical, not part of this study, within a period either prior to or after equal to 10 half-lives of the radiopharmaceutical; * Any condition that in the opinion of the Principal Investigator or designee could increase risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with collection of the data such as: * Inability to lie still or unable to tolerate a supine position with arms up over the head for up to a 60-minute PET scan due to chronic back/shoulder pain or arthritis as assessed by physical examination and/or medical history; * Current or past history of major medical illness, i.e. severe kidney or liver problems; * 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;

Inclusion Criteria

Exclusion Criteria

* Male and female, 18-99 years of age and any race;
* Have had a prior clinical SPECT or PET MPI positive for ischemia in two myocardial segments and referred for invasive coronary angiography (ICA) or have had a prior clinical SPECT or PET MPI negative for ischemia or healthy adult normal volunteers who are asymptomatic, without history of cardiovascular disease or significant cardiovascular risk factors;

* Inability to receive and sign informed consent;
* Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 6-months prior to clinical SPECT or PET or in the intervening days between clinical SPECT or PET and research PET examination;
* Participants who have received chemotherapeutic agents within 6 months of enrollment;
* Heart failure (left ventricular ejection fraction ≤ 20%);
* Known non-ischemic cardiomyopathy;
* Inability to undergo pharmacologic stress testing with regadenoson (Lexiscan). Contraindications include:
* Symptomatic bradycardia or second to third degree atrioventricular (AV) block;
* Pre-existing obstructive lung disease with active wheezing, i.e., COPD, asthma with active wheezing that precludes the safe administration of the pharmacological stress agent 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);
* Women who are pregnant or breastfeeding;
* Severe claustrophobia;
* Weight ≥ 500 lbs (weight limit of PET/CT table);
* Administration of any diagnostic or therapeutic radiopharmaceutical, not part of this study, within a period either prior to or after equal to 10 half-lives of the radiopharmaceutical;
* Any condition that in the opinion of the Principal Investigator or designee could increase risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with collection of the data such as:
* Inability to lie still or unable to tolerate a supine position with arms up over the head for up to a 60-minute PET scan due to chronic back/shoulder pain or arthritis as assessed by physical examination and/or medical history;
* Current or past history of major medical illness, i.e. severe kidney or liver problems;
* 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;

Contacts and Locations

Principal Investigator

Pamela K Woodard, M.D

PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine

St Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Pamela K Woodard, M.D, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-11

Study Completion Date2025-12-19

Study Record Updates

Study Start Date2022-11-11

Study Completion Date2025-12-19

Terms related to this study

Keywords Provided by Researchers

Myocardial Perfusion imaging
Pharmacological Stress
Positron Emission Tomography
Myocardial Blood Flow

Additional Relevant MeSH Terms

Coronary Artery Disease