Back to resultsPhase-I Study of Radiolabeled DFH-12 (PulmoBind) for Molecular Imaging of the Pulmonary Circulation
Primary Purpose
Pulmonary Disease, Pulmonary Hypertension
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
99mTC-PulmoBind
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Disease
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)
Sites / Locations
- Montreal Heart Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DFH-12 PulmoBind
Arm Description
DFH-12 PulmoBind - 3 doses of; 5mCi for 5 subjects, 10mCifor 5 subjects and 15mCi for 10 subject
Outcomes
Primary Outcome Measures
To determine optimal dose of PulmoBind to be administered for lung imaging in humans
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01539889
First Posted
February 22, 2012
Last Updated
September 30, 2014
Sponsor
Montreal Heart Institute
1. Study Identification
Unique Protocol Identification Number
NCT01539889
Brief Title
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
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montreal Heart Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Pulmonary Hypertension
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DFH-12 PulmoBind
Arm Type
Experimental
Arm Description
DFH-12 PulmoBind - 3 doses of; 5mCi for 5 subjects, 10mCifor 5 subjects and 15mCi for 10 subject
Intervention Type
Radiation
Intervention Name(s)
99mTC-PulmoBind
Intervention Description
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.
Primary Outcome Measure Information:
Title
To determine optimal dose of PulmoBind to be administered for lung imaging in humans
Description
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.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jocelyn Dupuis, MD
Organizational Affiliation
Montreal Heart
Official's Role
Study Director
Facility Information:
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
27234509
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.
Results Reference
derived
PubMed Identifier
25812438
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.
Results Reference
derived
Learn more about this trial
Phase-I Study of Radiolabeled DFH-12 (PulmoBind) for Molecular Imaging of the Pulmonary Circulation
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