Status:
COMPLETED
Phase-II Study of the Use of PulmoBind for Molecular Imaging of Pulmonary Hypertension
Lead Sponsor:
Montreal Heart Institute
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 inc...
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 exclusive...
Eligibility Criteria
Inclusion
- HEALTHY VOLUNTEERS:
- Male of female participants greater than 18 years of age,
- Female participants must be post-menopausal (defined as two year after last menstrual cycle) or surgically sterilized or use 1 form of contraception with a urine negative pregnancy test (commercial brand: first response kit) within 2 hours of study drug injection,
- Baseline measurements must be within limits of normal or judged non-clinically significant by the investigator:
- Blood pressure systolic 90 mmHg to 140 mmHg,and diastolic 50 mmHg to 90 mmHg;
- Heart rate: 50 to 100 beats per minute;
- Oral temperature: less than 37.6C;
- Respiratory rate: 12 to 20 breaths per minute;
- Lung function testing within 6 months;
- Electrocardiogram in the past three years;
- Chest X-Ray in the past three years;
- Electrocardiogram.
Exclusion
- Any known chronic or acute medical condition with or without the need for chronic pharmacologic therapy or any condition that may interfere with normal biodistribution of PulmoBind. This includes but is not restricted to: lung parenchymal or lung vascular diseases such as chronic obstructive pulmonary disease, bronchitis, lung cancer, pleural effusion, emphysema, asthma, pulmonary fibrosis, occupational lung disease,pulmonary hypertension (primary or secondary), systemic hypertension, diabetes, cancer, kidney disease, liver disease, heart failure or previous myocardial infarction, coronary artery disease, peripheral vascular disease or inflammatory disease,
- Participants requiring chronic administration of any substance for a medical condition,
- Active smoking or history of smoking within 6 months,
- Alcoholism or known substance abuse,
- Psychotic,addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements,
- Unable to tolerate study procedures (e.g. venipuncture, movement restrictions during imaging),
- Previous nuclear medicine study within one week (to avoid cross-contamination).
- PULMONARY HYPERTENSION PARTICIPANTS:
- Inclusion Criteria:
- Male of female participants greater than 18 years of age and upper age 70,
- Female participants must be post-menopausal (defined as two year after last menstrual cycle) or surgically sterilized or use 1 form of contraception with a urine negative pregnancy test (commercial brand: first response kit) within 2 hours of study drug injection,
- Diagnosis of pulmonary hypertension (PH) according to the Dana Point PH classification of the following types:
- Type I: idiopathic, heritable or scleroderma spectrum of disease,
- Type IV: unoperated chronic thromboembolic PH.
- Participants with chronic thromboembolic pulmonary hypertension (CTEPH) must have a previous positive V/Q scan and multiple chronic/organised occlusive thrombi/emboli in the pulmonary arteries (main, lobar, segmental, subsegmental) on CT angiogram or conventional pulmonary angiography,
- Documented hemodynamic diagnosis of significant PH by right heart catheterization - performed at any time prior to Screening showing:
- Resting mean pulmonary arterial pressure (mPAP) \> 25 mmHg and
- Resting pulmonary vascular resistance (PVR) \> 240 dyn/s.cm5 and
- Resting capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVDEP) ≤ 15 mmHg (if available),
- New York Heart Association (NYHA) functional class II-III,
- Six minutes walking distance test of ≥ 250 meters, and ≤ 450 meters within 6 months,
- Echocardiogram documented in the participants medical history (including an agitated saline study),
- Computed tomography of the chest documented in the participants medical history.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02216279
Start Date
September 1 2014
End Date
September 1 2015
Last Update
September 30 2015
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
2
Sir Mortimer B.Davis Jewish General Hospital
Montreal, Quebec, Canada
3
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, Canada