Pulmonary hypertension or elevation of the pressure in the pulmonary vessels, results from various clinical conditions. It may be idiopathic (of unknown cause) or associated with numerous diseases including cardiovascular and lung disorders. Affected individuals suffer from progressive shortness of breath and, in its most sever forms; pulmonary hypertension carries a worse prognosis than many types of cancer. There is no test currently that can easily and non-invasively detect abnormalities of the pulmonary circulation. Presently there is no cure for pulmonary hypertension and substantial research efforts are dedicated to the development of new drugs that will stop progression or better yet, reverse the disease process. The investigators do not know if any of the drugs currently commercialized for pulmonary hypertension directly improve the status of the pulmonary vessels since no test currently provides this information. Direct earlier detection of lung vessel abnormalities associated with pulmonary hypertension using a sensitive and non-invasive test would allow not only earlier testing of these and of new drugs, but would provide a much better surrogate of disease severity allowing more efficient pre-clinical drug testing. The aim of this phase II study is to evaluate the safety of PulmoBind in participants with pulmonary hypertension and its potential to detect abnormal pulmonary circulation associated within pulmonary hypertension.
Currently there is only one radiopharmaceutical agent approved in Canada (and the world) for clinical imaging of the pulmonary circulation, metastable isotope 99 of technetium. This agent is exclusively used for the diagnosis of physical defects of the circulation due to pulmonary embolus. There is imperative need for new lung tracers that will provide a greater safety profile while enabling functional as well as anatomical imaging of the pulmonary circulation. A novel adrenomedullin derivative has been developed, for molecular imaging of the pulmonary circulation. PulmoBind is labelled with metastable isotope 99 of technetium, the most commonly used imaging isotope in clinical nuclear medicine. PulmoBind is a adrenomedullin derivative specifically designed to bind to the adrenomedullin receptor while avoiding any hemodynamic effects. This novel tracer has the potential to help in the diagnosis and follow-up of various disorders of the pulmonary circulation for which there is currently no alternative. In PulmoBind I three escalating doses were administered and safety was assessed. The product was well tolerated and there were no safety concerns. Imaging revealed predominant lung uptake.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
45
PulmoBind is a peptide derived from human adrenomedullin (hAM1-52), labelled with 99mTc (imaging isotope used in clinical medicine).
Montreal Heart Institute
Montreal, Quebec, Canada
Sir Mortimer B.Davis Jewish General Hospital
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, Canada
To determine the absence of allergic reaction after repeated exposures to PulmoBind in healthy participants
Time frame: Static lung uptake 10 minutes duration post injection
To determine the safety of PulmoBind in participants diagnosed with pulmonary hypertension.
Time frame: Static lung uptake 10 minutes duration post injection
To determine the capacity of PulmoBind lung scan for the detection of abnormal pulmonary circulation associated with pulmonary hypertension.
This is an efficacy outcome
Time frame: Status lung uptake 10 minutes duration post injection
To determine the intra-subject variability for quantification of PulmoBind lung uptake in control participants
Time frame: Status lung uptake 10 minutes duration post injection
Determine the capacity of PulmoBind lung scan to diagnose pulmonary perfusion defects in participants with chronic thromboembolic pulmonary hypertension.
Time frame: Status lung uptake 10 minutes duration post injection
To correlate lung PulmoBind scan results with parameters of the severity of pulmonary hypertension: 6 minutes walking distance, New York Heart Association functional class, pulmonary artery pressure measured by echo, pulmonary artery pressure measured by
Time frame: Status lung uptake 10 minutes duration post injection
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