Clinical trial NCT01539889: Phase-I Study of Radiolabeled DFH-12 (PulmoBind) for Molecular Imaging of the Pulmonary Circulation
Official title: Phase-I Study of Radiolabeled DFH-12 (PulmoBind) for Molecular Imaging of the Pulmonary Circulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Disease
Pulmonary Hypertension
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2012-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Pulmonary hypertension (PH) can be the result of various clinical conditions. It may be idiopathic or associated with various cardiovascular and lung disorders. Currently there is no test that can non-invasively detect abnormalities of the pulmonary circulation. There is a growing need for a non-invasive method to detect PH. There currently exists only ne agent approved in Canada for clinical imaging of the pulmonary circulation, 99mTc-labeled macroaggregates. This agent is exclusively used for the diagnosis of physical defects of the circulation due to pulmonary embolus. This agent is larger than small pulmonary vessels, limiting its sensitivity to detect small vascular defects, as well as potential infectious risks since albumin macroaggregates are derived from human albumin. There is need then for new lung tracers that could provide a greater safety profile while enabling functional as well as anatomical imaging of the pulmonary circulation. DFH-12 (PulmoBind) is a peptide derived from human adrenomedullin (hAMI-52). Hence the development of this novel AM derivative, PulmoBind, for molecular imaging of the pulmonary circulation. PulmoBind is labeled with 99mTc, the most commonly used imaging isotope in nuclear medicine.


Eligibility criteria: Inclusion Criteria:

* male or female greater than 18 years of age. Female subjects must be post-menopausal (defined as two years after menstrual cycle)
* within normal range for the following: BP systolic 100-140 mmHg and diastolic 50-90 mmHg;
* HR 60-100 beats per minute;
* oral temperature less than 37.6 degrees Centigrade;
* respiratory rate 12-20 breaths per minute;
* normal lung function tests;
* normal echocardiogram including estimation of pulmonary artery systolic pressure;
* normal chest x-ray; Normal electrocardiogram

Exclusion Criteria:

* 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 DFH-12. Includes but not limited 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;
* subjects requiring chronic administration of any substance for a medical condition, active smoking or history of smoking for more than one year in the past 10 years, known self-reported alcoholism (active or abstinent);
* unable to tolerate study procedures ex.(venipuncture, movement restrictions during imaging);
* previous nuclear study since one week (to avoid cross-contamination)

Primary outcomes:
measure: To determine optimal dose of PulmoBind to be administered for lung imaging in humans
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart
name: Jocelyn Dupuis, MD
role: STUDY_DIRECTOR
References:
citation: Levac X, Harel F, Finnerty V, Nguyen QT, Letourneau M, Marcil S, Fournier A, Dupuis J. Evaluation of pulmonary perfusion by SPECT imaging using an endothelial cell tracer in supine humans and dogs. EJNMMI Res. 2016 Dec;6(1):43. doi: 10.1186/s13550-016-0198-3. Epub 2016 May 27.
citation: Harel F, Levac X, Nguyen QT, Letourneau M, Marcil S, Finnerty V, Cossette M, Fournier A, Dupuis J. Molecular imaging of the human pulmonary vascular endothelium using an adrenomedullin receptor ligand. Mol Imaging. 2015;14. doi: 10.2310/7290.2015.00003.