A team led by researchers at the Montreal Heart Institute in Canada is currently recruiting participants for a clinical trial designed to assess the safety and efficacy of a new non-invasive molecular imaging agent – PulmoBind – for the early diagnosis of patients with pulmonary hypertension. The trial is entitled “Phase-II Study of the Use of PulmoBind for Molecular Imaging of Pulmonary Hypertension” (NCT02216279).
Pulmonary hypertension is a life-threatening condition characterized by the increase of blood pressure in the pulmonary vessels that supply blood to the lungs, which can lead to shortness of breath, increased pulmonary vascular resistance, right heart failure and eventually death. Pulmonary hypertension can be idiopathic, meaning that it has an unknown cause, or the result of several medical conditions including cardiovascular and lung disorders. There is no cure for pulmonary hypertension and patients usually have a poor prognosis.
Currently, there is no test available to easily identify possible abnormalities and evaluate the general status of pulmonary vessels. An early detection of lung vessel anomalies linked to pulmonary hypertension through a sensitive and non-invasive technique would allow testing drug efficacy and would offer a better surrogate of disease severity to conduct pre-clinical drug tests.
The goal of this Phase 2 trial study is to assess the safety and efficacy of PulmoBind in detecting pulmonary circulation anomalies associated to pulmonary hypertension. PulmoBind is a peptide derived from human adrenomedullin, which is radio-labelled with metastable isotope 99 of technetium (99mTc, the most commonly used imaging isotope in clinical nuclear medicine). Preliminary animal studies have shown that PulmoBind allows a rapid quantification of lung blood vessels through a standard nuclear medicine camera and suggested that it could be employed as a marker of lung vascular disease.
In the trial, PulmoBind will be tested in patients with pulmonary hypertension and healthy non-smoking controls. Participants of both genders aged between 18 and 70 years are eligible for this trial. Healthy volunteers should have blood pressure, heart rate, and lung function result tests within the normal range. Volunteers who smoke or have a medical condition that may interfere with the normal PulmoBind distribution will be excluded.
The primary outcome measures are, in terms of safety, the absence of allergic reaction upon repeated exposures to PulmoBind in healthy controls and patients with pulmonary hypertension, and in terms of efficacy, the ability of PulmoBind lung scan to identify pulmonary circulation anomalies linked to pulmonary hypertension.
The research team is currently recruiting participants to enroll on this trial. For more information, please contact Dr. Jocelyn Dupuis at 514 376-3330 ext. 3542 or e-mail jocelyn.[email protected]
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