Water PET MPI for Coronary Heart Disease

(RAPID-WATER Trial)

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen by Marcelo DiCarli, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: MedTrace Pharma A/S

Must not be taking: PDE5 inhibitors

Disqualifiers: Cardiac disease, Severe COPD, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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 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 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.

Will I have to stop taking my current medications?

The trial requires that you stop taking sildenafil (Viagra), oral dipyridamole (Persantine, Aggrenox), or any PDE5 inhibitors (like tadalafil, avanafil, vardenafil) at least 24 hours before the study treatment. For other medications, the protocol does not specify, so it's best to discuss with the trial team.

What data supports the effectiveness of the treatment [O-15]-Water PET Cardiac Perfusion Imaging for coronary heart disease?

Research shows that [O-15]-Water PET Cardiac Perfusion Imaging can help predict the need for procedures like coronary angiography and revascularization in patients with coronary artery disease, indicating its usefulness in guiding treatment decisions. ^{1 2 3 4 5}

Is [O-15]-Water PET MPI safe for humans?

The use of [O-15]-Water PET for imaging has been around for a long time and is considered safe for humans. The short half-life of the oxygen-15 isotope used in the imaging process means it doesn't stay in the body for long, which helps ensure safety. ^{1 2 6 7 8}

How does the Water PET MPI treatment differ from other treatments for coronary heart disease?

Water PET MPI uses a special imaging technique with oxygen-15-labeled water to measure blood flow in the heart, helping doctors decide if invasive procedures are needed. This approach is unique because it provides detailed, quantitative information about heart blood flow, which can guide treatment decisions more precisely than some other imaging methods. ^{1 2 5 7 9}

Eligibility Criteria

Adults referred for coronary artery disease (CAD) testing, who can undergo PET imaging and are not pregnant or breastfeeding. They must agree to use contraception and have had recent non-invasive CAD tests or invasive angiography with minimal findings. Excluded are those with significant heart disease history, severe lung conditions, certain medication usage, or involvement in other drug trials.

Inclusion Criteria

I had a heart scan that showed either no issues or very minor artery problems.

I will use birth control until the study ends.

I am not pregnant or breastfeeding and am using birth control.

Exclusion Criteria

Participants who have participated in another research study using investigational drugs within the 30 days prior to enrollment or through the duration of the trial

You are not able to have any of the required imaging tests.

I have a history of heart disease or issues like a heart attack or weak heart muscle.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PET Imaging Session

Participants receive two doses of [15-O]-H2O for PET imaging, one at rest and one during pharmacological stress with adenosine

1 day

1 visit (in-person)

Safety Follow-up

A safety follow-up phone call occurs 24 ± 8 hours after the PET imaging session

1 day

1 call (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Treatment Details

Interventions

• [O-15]-Water PET Cardiac Perfusion Imaging (Radiopharmaceutical)
• [O-15]-Water PET Myocardial Perfusion Imaging (MPI) (Radiopharmaceutical)

Trial Overview [O-15]-Water PET Myocardial Perfusion Imaging is being tested on participants with suspected CAD. The study involves two doses of [15-O]-H2O during a single PET scan session under rest and stress conditions induced by adenosine at multiple sites in the US and Europe.

Participant Groups

Group I: [O-15]-Water PET Myocardial Perfusion Imaging (MPI) Experimental Treatment 1 Intervention

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).

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Virginia Medical Center Charlottesville, VA

University of Pittsburgh Medical Center Pittsburgh, PA

BAMF Healthcare Grand Rapids, MI

Mayo Clinic Rochester, MN

More Trial Locations

Who Is Running the Clinical Trial?

MedTrace Pharma A/S Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Extracardiac findings with increased perfusion during clinical O-15-H2O PET/CT myocardial perfusion imaging: A case series. [2023] Label="BACKGROUND">Coincidental extracardiac findings with increased perfusion were reported during myocardial perfusion imaging (MPI) with various retention radiotracers. Clinical parametric O-15-H2O PET MPI yielding quantitative measures of myocardial blood flow (MBF) was recently implemented at our facility. We aim to explore whether similar extracardiac findings are observed using O-15-H2O.

2. United States pubmed.ncbi.nlm.nih.gov

Clinical impact of quantitative [15O] H2O PET/CT myocardial perfusion imaging on decision-making regarding invasive management of coronary artery disease. [2022] Label="BACKGROUND">This study was performed to determine the impact of oxygen-15-labeled water ([15O] H2O) positron emission tomography/computed tomography (PET/CT) myocardial perfusion imaging (MPI) on referral for invasive coronary angiography (ICA) and revascularization.

3. Netherlands pubmed.ncbi.nlm.nih.gov

Myocardial perfusion imaging with 13N-ammonia PET is a strong predictor for outcome. [2022] The aim of the present study was to assess the long-term predictive value of myocardial perfusion imaging (MPI) with (13)N-ammonia positron emission tomography (PET) in patients with suspected myocardial perfusion abnormality. At present, outcome data on the predictive value of MPI in (13)N-ammonia PET exist only for rather small patient populations.

4. United States pubmed.ncbi.nlm.nih.gov

Women with high exercise tolerance and the role of myocardial perfusion imaging. [2020] Myocardial perfusion imaging (MPI) provides incremental diagnostic and prognostic information, even in patients with high exercise tolerance.

5. England pubmed.ncbi.nlm.nih.gov

Myocardial perfusion imaging by 15O-H2O positron emission tomography predicts clinical revascularization procedures in symptomatic patients with previous coronary artery bypass graft. [2023] Label="Aims" NlmCategory="UNASSIGNED">We wanted to assess if 15O-H2O myocardial perfusion imaging (MPI) in a clinical setting can predict referral to coronary artery catheterization [coronary angiography (CAG)], execution of percutaneous coronary intervention (PCI), and post-PCI angina relief for patients with angina and previous coronary artery bypass graft (CABG).

6. England pubmed.ncbi.nlm.nih.gov

Validation protocol for current good manufacturing practices production of [15O]water for hybrid PET/MR studies. [2021] Oxygen-15 (O; t½ = 122.4 s) has been used for nuclear imaging experiments since the beginning of the field. With the advent of simultaneous hybrid PET/MR technology, [O]water has seen a resurgence and remains the gold standard method for quantitative blood flow studies. The short half-life presents a nontrivial challenge to applying current good manufacturing practices production methods to maintain patient safety.

7. Iran pubmed.ncbi.nlm.nih.gov

Association between Cardiovascular Risk Factors and High-Risk Features in Myocardial Perfusion Imaging: A Multicenter Study. [2023] Myocardial perfusion imaging (MPI) is a noninvasive method with acceptable sensitivity and specificity in diagnosing coronary artery disease (CAD) in moderate-risk patients, including those with CAD risk factors.

8. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

[Normal and Near Normal Myocardial Perfusion Imaging Data Analysis: Two-Year Major Adverse Cardiac Event]. [2022] Myocardial perfusion imaging (MPI) is the method most commonly used to assess patients with suspected coronary artery disease for the presence of myocardial ischemia and risk of subsequent adverse cardiac events. Studies are limited on the incidence of major adverse cardiac event (MACE) in patients with normal MPI results.

9. United States pubmed.ncbi.nlm.nih.gov

Prognostic study of cardiac events in Japanese patients with chronic kidney disease using ECG-gated myocardial Perfusion imaging: Final 3-year report of the J-ACCESS 3 study. [2020] Myocardial perfusion imaging (MPI) is considered useful for risk stratification among patients with chronic kidney disease (CKD), without renal deterioration by contrast media.