Phase-II Study of the Use of PulmoBind for Molecular Imaging of Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): PulmoBind
Intervention type(s): Drug
Intervention description(s): PulmoBind is a peptide derived from human adrenomedullin (hAM1-52), labelled with 99mTc (imaging isotope used in clinical medicine).
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Pulmonary; Hypertension; PH; PulmoBind; Imaging