Phase-II Study of the Use of PulmoBind for Molecular Imaging of Pulmonary Hypertension

NCT02216279 | Completed Phase 2 DMC

• 1 other identifier: PulmoBind II safety Trial
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

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 including cardiovascular and lung disorders. Affected individuals suffer from progressive shortness of breath and, in its most sever forms; pulmonary hypertension carries a worse prognosis than many types of cancer. There is no test currently that can easily and non-invasively detect abnormalities of the pulmonary circulation. Presently there is no cure for pulmonary hypertension and substantial research efforts are dedicated to the development of new drugs that will stop progression or better yet, reverse the disease process. The investigators do not know if any of the drugs currently commercialized for pulmonary hypertension directly improve the status of the pulmonary vessels since no test currently provides this information. Direct earlier detection of lung vessel abnormalities associated with pulmonary hypertension using a sensitive and non-invasive test would allow not only earlier testing of these and of new drugs, but would provide a much better surrogate of disease severity allowing more efficient pre-clinical drug testing. The aim of this phase II study is to evaluate the safety of PulmoBind in participants with pulmonary hypertension and its potential to detect abnormal pulmonary circulation associated within pulmonary hypertension.

Conditions

Pulmonary Hypertension

Keywords

Pulmonary; Hypertension; PH; PulmoBind; Imaging

Outcome Measures

Primary Outcomes (3)

• To determine the absence of allergic reaction after repeated exposures to PulmoBind in healthy participants

  Static lung uptake 10 minutes duration post injection

• To determine the safety of PulmoBind in participants diagnosed with pulmonary hypertension.

  Static lung uptake 10 minutes duration post injection

• To determine the capacity of PulmoBind lung scan for the detection of abnormal pulmonary circulation associated with pulmonary hypertension.

  This is an efficacy outcome

  Status lung uptake 10 minutes duration post injection

Secondary Outcomes (3)

• To determine the intra-subject variability for quantification of PulmoBind lung uptake in control participants

  Status lung uptake 10 minutes duration post injection

• Determine the capacity of PulmoBind lung scan to diagnose pulmonary perfusion defects in participants with chronic thromboembolic pulmonary hypertension.

  Status lung uptake 10 minutes duration post injection

• To correlate lung PulmoBind scan results with parameters of the severity of pulmonary hypertension: 6 minutes walking distance, New York Heart Association functional class, pulmonary artery pressure measured by echo, pulmonary artery pressure measured by

  Status lung uptake 10 minutes duration post injection

Study Arms (2)

Pulmonary Hypertension Patients

EXPERIMENTAL

PulmoBind is a peptide derived from human adrenomedullin (hAM1-52), labelled with 99mTc (imaging isotope used in clinical medicine).

Drug: PulmoBind

Control Non-Smoking Participants

ACTIVE COMPARATOR

PulmoBind is a peptide derived from human adrenomedullin (hAM1-52), labelled with 99mTc (imaging isotope used in clinical medicine).

Drug: PulmoBind

Interventions

PulmoBind DRUG

PulmoBind is a peptide derived from human adrenomedullin (hAM1-52), labelled with 99mTc (imaging isotope used in clinical medicine).

Control Non-Smoking Participants; Pulmonary Hypertension Patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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:

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (3)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Sir Mortimer B.Davis Jewish General Hospital

Montreal, Quebec, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Québec, Quebec, Canada

Location

Related Publications (1)

• Harel F, Langleben D, Provencher S, Fournier A, Finnerty V, Nguyen QT, Letourneau M, Levac X, Abikhzer G, Guimond J, Mansour A, Guertin MC, Dupuis J. Molecular imaging of the human pulmonary vascular endothelium in pulmonary hypertension: a phase II safety and proof of principle trial. Eur J Nucl Med Mol Imaging. 2017 Jul;44(7):1136-1144. doi: 10.1007/s00259-017-3655-y. Epub 2017 Feb 24.

  PMID: 28236024 DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary; Hypertension

Interventions

adrenomedullin (22-52), glycyl-glycyl-alanyl-glycyl-cysteinyl-(PEG)4-cysteinyl-

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jocelyn Dupuis, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: August 13, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 30, 2015

Record last verified: 2015-09

Locations

CA (3)