This a Phase 3, prospective, open-label, multicenter study of [15-O]-H2O injection for PET imaging of subjects with suspected CAD. Approximately 182 evaluable participants with suspected CAD referred for noninvasive stress testing will be included in the study at approximately 10 study sites in the United States and Europe. Approximately 215 participants will be enrolled to account for an estimated 15% drop-out rate. Screening assessments will occur between -21 and 0 days prior to enrollment to confirm eligibility. All participants will receive two doses of [15-O]-H2O as part of a single PET imaging session (one dose at rest and one during pharmacological stress with adenosine). A safety follow-up phone call will occur 24 ± 8 hrs after completion of the [15-O]-H2O scan. If enrolled under Pathway 2 (EU only) no follow-up call will be performed.
Full Title of Study: “A Phase 3, Multicenter, Open Label Study to Confirm the Diagnostic Potential of Intravenously Administered [15-O]-H2O to Identify Coronary Artery Disease During Pharmacological Stress and Resting Conditions Using PET Imaging”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
- Study Primary Completion Date: January 31, 2024
- Drug: [O-15]-Water PET Cardiac Perfusion Imaging
- [15-O]-H2O injection is a novel PET imaging agent labeled with the radioisotope [15-O] administered as an intravenous (IV) injection. Participants will receive [15-O]-H2O treatment twice as a part of a single day imaging session. All participants will receive two IV boluses of [15-O]-H2O injection in a peripheral vein; one at rest and one during pharmacological stress.
Arms, Groups and Cohorts
- Experimental: [O-15]-Water PET Cardiac Perfusion Imaging
- All participants with suspected CAD will receive two doses of [15-O]-H2O as part of a single PET imaging session (one dose at rest and one during pharmacological stress with adenosine).
Clinical Trial Outcome Measures
- Sensitivity and specificity of the [15-O]-H2O PET study using the truth-standard of ICA with FFR or CCTA.
- Time Frame: 30 days
- All efficacy assessments will be based on a blinded analysis of all imaging data. The primary efficacy endpoints of the study are the sensitivity and specificity defined as follows: Sensitivity = Number of participants with true-positive [15-O]-H2O assessments / Number of participants with CAD Specificity = Number of participants with true-negative [15-O]-H2O assessments / Number of participants with no CAD
- Sensitivity and specificity of [15-O]-H2O PET MPI in participants of special clinical interest (female, BMI≥30, diabetics, multivessel disease)
- Time Frame: 30 days
- Subgroup analyses will be performed using the independent readers’ assessments to determine the sensitivity, specificity, and accuracy of P3 MT-100 [15-O]-H2O PET in subjects of special clinical interest (female, BMI≥30, diabetics, MVD). The sensitivity and specificity are defined as follows: Sensitivity = Number of participants with true-positive [15-O]-H2O assessments / Number of participants with CAD Specificity = Number of participants with true-negative [15-O]-H2O assessments / Number of participants with no CAD
- Incidence (number and percent of participants) of treatment-emergent adverse events (TEAEs) and procedure-related AEs by MedDRA system organ class (SOC) and preferred term (PT).
- Time Frame: 30 days
- A TEAE is an event that started or worsened in severity at or after start of [15-O]-H2O injection. Such adverse events (AEs) and serious adverse events (SAEs) will be followed from the start time of [15-O]-H2O administration through 24 ± 8 hours after the start time of the second (stress) [15-O]-H2O administration. This analysis will be performed on the overall safety population.
Participating in This Clinical Trial
1. Male and female participants ≥18 years; 2. Informed consent form (ICF) read, signed, and dated prior to any study procedures being performed; 3. Participants who fall into any one of the following categories: 1. Have been referred for an ICA directly of after non-invasive testing (e.g., SPECT or PET MPI, stress echo, CCTA, ETT). 2. Had a 15O H2O MPI study performed according to the study protocol and was referred for ICA (EU sites only). 3. Had an ICA with no intervention. However, if any stenosis >40% but ≤70% was observed, an FFR assessment was performed. 4. Had a CCTA with normal coronaries or minimal CAD (no stenosis >20%). The SPECT study, PET 15O-H2O study, and ICA or CCTA testing need to be completed within a 30-day window, with time 0 defined as the date of the first of these three tests. 4. Women of Child Bearing Potential (WOCBP) must be non-pregnant, and non-lactating. For women of childbearing potential, the results of a urine human chorionic gonadotropin (HCG) pregnancy test (with the result known on the day of drug administration) must be negative; these patients must be practicing appropriate birth control from time of the screening visit to 30 days after the radiopharmaceutical administration. For women who are either surgically sterile (have a documented bilateral tubal ligation or oophorectomy and/or hysterectomy) or are post-menopausal (cessation of menses for more than 1 year); enrollment in the study without a pregnancy test at screening is allowed. 5. Participants are able to comply with all study procedures as described in the protocol. Exclusion Criteria:
1. Participants are unable to undergo (even partially) any of the imaging procedures; 2. Participants with a known history of cardiac disease including: 1. myocardial infarction, previous coronary revascularization, or chronic ischemic cardiomyopathy 2. primary myocardial disease such as cardiac amyloidosis or hypertrophic cardiomyopathy 3. known left ventricular dysfunction 3. Participants in whom adenosine stress testing is contraindicated, including but not limited to: 1. Participants with severe COPD or chronic asthma. 2. Participants with second- or third-degree atrioventricular block without a pacemaker. 4. Participants with claustrophobia to an extent that would limit their ability to undergo SPECT and PET imaging (patients whose claustrophobia is known to be readily controlled with drugs or psychological support may be enrolled). 5. Participants who are on sildenafil (Viagra) or oral dipyridamole (Persantine, Aggrenox) therapy and for whom its use cannot be terminated or suspended for ≥24 hours prior to treatment of study drug. 6. Participants with significant co-morbidities that would prevent appropriate completion of the protocol procedures. 7. Participants who have participated in another research study using investigational drugs within the 30 days prior to enrollment (Day 0) (patients in observational studies with approved agents and participants known to be on placebo may be enrolled). 8. Participants who have previously participated in this study. 9. Participants with a close affiliation with the investigational site, defined as a close relative to the Investigator, or a dependent person such as an employee, student or intern at the investigational site.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- MedTrace Pharma A/S
- Provider of Information About this Clinical Study
- Overall Official(s)
- Rune Wiik Kristensen, Study Chair, MedTrace Pharma A/S
- Overall Contact(s)
- Taylor A Williams, 16178024048, email@example.com
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