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RAdiolabeled Perfusion to Identify Coronary Artery Disease Using WAter To Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW)

NCT05134012 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2026-02-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

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

\[15-O\]-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.

Sponsors & Collaborators

  • MedTrace Pharma A/S

    lead INDUSTRY

Principal Investigators

  • Nicholas Borys, MD · MedTrace Pharma A/S

  • Marcelo DiCarli, MD · Brigham and Women's Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-08
Primary Completion
2026-04-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Denmark
  • Germany
  • Netherlands
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05134012 on ClinicalTrials.gov