Phase-I Study of Radiolabeled DFH-12 (PulmoBind) for Molecular Imaging of the Pulmonary Circulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT01539889
First received: February 22, 2012
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease
Pulmonary Hypertension
Radiation: 99mTC-PulmoBind
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Phase-I Study of Radiolabeled DFH-12 (PulmoBind) for Molecular Imaging of the Pulmonary Circulation

Resource links provided by NLM:


Further study details as provided by Montreal Heart Institute:

Primary Outcome Measures:
  • To determine optimal dose of PulmoBind to be administered for lung imaging in humans [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    To determine the optimal dose of Pulmobind by evaluating the safety and efficacy in three groups of subjects with 3 different doses of study drug; 5mCi, 10mCi, and 15 mCi.For safety evaluation we will provide pharmacokinetic and biodistribution data following injections of the 3 doses mentioned. Vital signs, hematology and biochemistry will also be captured for each of the doses up to 24 and 48 hours after injections of PulmoBind. Furthermore local and systemic reactions 24 hours and 48 hours after injections of PulmoBind will also be captured.


Enrollment: 20
Study Start Date: December 2011
Study Completion Date: January 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DFH-12 PulmoBind
DFH-12 PulmoBind - 3 doses of; 5mCi for 5 subjects, 10mCifor 5 subjects and 15mCi for 10 subject
Radiation: 99mTC-PulmoBind
DFH-12 (PulmoBind) is a peptide derived from human adrenomedullin (hAMI-52). Adrenomedullin (AM) is a 52-amino acid peptide produced by many tissues in the body, including the vascular endothelium. 3 radiolabeled doses of PulmoBind will be used in this study (5mCi, 10mCi and 15mCi) 5 healthy subjects per dose for the 5 mci and the 10 mci groups but 10 subjects will be used for the 15 mci group.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539889

Locations
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Montreal Heart Institute
Investigators
Study Director: Jocelyn Dupuis, MD Montreal Heart
  More Information

No publications provided

Responsible Party: Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT01539889     History of Changes
Other Study ID Numbers: The PulmoBind Safety Trial
Study First Received: February 22, 2012
Last Updated: July 16, 2013
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Lung Diseases
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014