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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539889
• Other study ID #: The PulmoBind Safety Trial
• Status: Completed
• Phase: Phase 1
• First received: February 22, 2012
• Last updated: September 30, 2014
• Start date: December 2011
• Est. completion date: January 2013

Study information

• Verified date: September 2014
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Pulmonary Disease
• Pulmonary Hypertension

Intervention

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.

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	48 hours	Yes