The Montreal Heart Institute is currently recruiting patients for a Phase-IIc clinical trial that is evaluating the safety of PulmoBind in participants with pulmonary hypertension and its potential to detect abnormal pulmonary circulation associated within pulmonary hypertension. (ClinicalTrials.gov Identifier: NCT02216279).
Pulmonary hypertension is a condition that causes gradual loss of breathing capacity. At the moment, there is no available test to easily and non-invasively assess potential abnormalities of the pulmonary circulation. At the same time, researchers are only focused on developing drugs that will stop or reverse disease progression. Early detection of lung vessel abnormalities related to pulmonary hypertension using a non-invasive and sensitive test would allow earlier detection and testing of new drugs, and provide a better picture of disease severity.
In Canada, there is currently only one approved radiopharmaceutical agent for clinical imaging of pulmonary circulation, called metastable isotope 99 of technetium. This agent is utilized to diagnose physical defects of the circulation due to pulmonary embolus. However, there is a need for novel lung tracers that can offer more safety while allowing functional and anatomical imaging of pulmonary circulation.
PulmoBind is labelled with metastable isotope 99 of technetium and is a adrenomedullin derivative designed to bind to the adrenomedullin receptor and avoid hemodynamic effects. This novel tracer can help in the diagnosis and follow-up of many conditions of the pulmonary circulation for which at the moment there are no alternatives.
The study started in September 2014 and is expected to conclude this May after studying a sample of 45 patients. Patients are eligible if they are male or female older than 18 years of age and no older than 70. Patients in the experimental arm must have Pulmonary Hypertension and will be assessed with PulmoBind, a peptide derived from human adrenomedullin (hAM1-52), labelled with 99mTc (imaging isotope used in clinical medicine). The control group that will serve as an active comparator is comprised of Non-Smoking Participants that will also be evaluated with PulmoBind.
The primary outcome measures are to examine the absence of allergic reaction after repeated exposures to PulmoBind in healthy participants for a time frame of Static lung uptake 10 minutes duration post injection; to determine the safety of PulmoBind in participants diagnosed with pulmonary hypertension; and to evaluate the capacity of PulmoBind lung scan for the detection of abnormal pulmonary circulation associated with pulmonary hypertension.
More information about the study and how to enroll can be found at: https://clinicaltrials.gov/ct2/show/NCT02216279?term=pulmonary+hypertension&rank=3