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Evaluation of Pulmonary Perfusion Heterogeneity and Compliance in Patients With Pulmonary Hypertension Using Positron Emission Tomography Imaging

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CT imaging, functional PET imaging
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pulmonary Arterial Hypertension focused on measuring pulmonary hypertension, PET imaging, CT/PET

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • General

    1. A signed and dated written informed consent is obtained from the subject.
    2. The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
    3. Available to complete the study.
    4. Able to lie flat and able to perform a 30 second breath hold.

  • Patients with Pulmonary Hypertension

    1. Subject is male or female aged = or > 18 years of age and < or = 70 years.
    2. Subject is diagnosed with pulmonary arterial hypertension (WHO Group I, by right heart catheterization, mean PA pressure > 25 and PCWP < 15) or exercise-induced pulmonary hypertension (by right heart catheterization + Level III cardiopulmonary exercise testing, mean PAP > 30 and PCWP < 20 during exercise, but normal at rest), with the most recent of above diagnostic tests taking place within 12 months of study entry.
    3. If patient has been on PAH-specific therapy, the therapy (agent and dose) has been unchanged for at least 3 months.

Exclusion Criteria:

  • General

    1. FEV1 and/or TLC < 70% predicted
    2. PCWP > 15 mm Hg
    3. Inability to perform the study (by primary MD or investigator assessment)
    4. Subjects who have a past or present disease, which as judged by the Investigators may affect the outcome of this study
    5. The subject has suspected history of drugs or alcohol abuse within the six months prior to the screening visit.
    6. The subject has a positive pregnancy test.
    7. The subject is unable to perform the respiratory manoeuvres necessary for the exam.
    8. The subject has been exposed to a radiation dose over the past year that, when added to the radiation dose expected in this study, would exceed permissible yearly exposure as determined by the MGH radiation safety committee.

  • Subjects with Pulmonary Hypertension

    1. Subject with clinical instability in the judgment of the investigator, or hospitalization for progression of pulmonary hypertension or right heart failure in the three months prior to the study.
    2. Subjects in whom PAH therapy has been escalated (additional agent started) within 3 months of enrolment.
    3. Subject with diagnosis of active tuberculosis, lung cancer, clinically overt bronchiectasis, allergic rhinitis, asthma, or COPD.
    4. Subject that had a respiratory tract infection in the 4 weeks prior to the screening visit and throughout the duration of the study.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

pulmonary hypertension

healthy controls

Arm Description

Patients with Group I pulmonary arterial hypertension and exercise-induced pulmonary hypertension to undergo CT imaging, functional PET imaging

healthy adults to serve as controls and to undergo the same study procedures: CT imaging, functional PET imaging

Outcomes

Primary Outcome Measures

Coefficient of variation of perfusion
Images will be generated with positron emission tomography that will be used to calculate the degreee to which the blood flow in the lung is patchy rather than smooth. The statistical measure of this is called the coefficient of variation.

Secondary Outcome Measures

Vascular compliance
Positron emission tomography images will be obtained during different phases of the heart beat that will show how the blood vessels in the lung stretch with ejection of blood from the heart. The change in volume of the blood vessels is called vascular compliance and is a measure of blood vessel stiffness.
Perfusion gradient
From the images of blood flow in the lung, the change in mean blood flow from the bottom of the lung to the top will be calculated. Normally, there is more blood flow at the bottom of the lung compared to the top, but this can be changed with lung disease.

Full Information

First Posted
October 25, 2011
Last Updated
March 21, 2018
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01461343
Brief Title
Evaluation of Pulmonary Perfusion Heterogeneity and Compliance in Patients With Pulmonary Hypertension Using Positron Emission Tomography Imaging
Official Title
Evaluation of Pulmonary Perfusion Heterogeneity and Compliance in Patients With Pulmonary Arterial Hypertension Using Functional Positron Emission Tomography Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
November 21, 2017 (Actual)
Study Completion Date
March 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to find out how the blood flow changes in the lungs of people with pulmonary hypertension compared to healthy individuals without pulmonary hypertension. We would like to find out if there are differences in how blood flows when subjects are given a drug to dilate (widen) the arteries in their lungs and when they breathe extra oxygen. We will compare the results to when subjects don't receive any drug or extra oxygen. We hope that knowing about these differences will help us to better understand pulmonary hypertension and how to diagnose it earlier.
Detailed Description
Pulmonary hypertension (PH) refers to abnormalities in the pulmonary vasculature associated with a diverse group of disorders. The World Health Organization (WHO) classifies pulmonary hypertension into five groups, with Group I comprising pulmonary arterial hypertension (formerly referred to as "primary pulmonary hypertension"). Although not currently a part of the WHO classification, exercise-induced pulmonary arterial hypertension (EIPAH), defined by normal pulmonary artery pressures at rest and elevation of pulmonary pressures with exercise, is increasingly recognized as a distinct clinical entity. In some patients, exercise-induced pulmonary hypertension may represent a precursor for developing an established elevation in pulmonary pressures at rest that defines PAH. Functional PET imaging has not previously been utilized to quantify perfusion and vascular compliance in patients with pulmonary arterial hypertension. The overall goal of this study is to evaluate regional lung perfusion, perfusion heterogeneity, and vascular compliance in patients with both exercise-induced and resting pulmonary hypertension using functional positron emission tomography imaging. Ultimately, if quantifiable differences between healthy subjects and patients with PAH are detected with 13NN and 11CO labeled PET, functional PET imaging may provide a useful imaging modality in early diagnosis of pulmonary hypertension and monitoring response to therapy. In this pilot study, we will recruit 10 adult patients with pulmonary hypertension (5 with PAH and 5 with EIPAH) who are on stable PAH-specific therapy (if any), and 5 healthy controls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
pulmonary hypertension, PET imaging, CT/PET

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pulmonary hypertension
Arm Type
Experimental
Arm Description
Patients with Group I pulmonary arterial hypertension and exercise-induced pulmonary hypertension to undergo CT imaging, functional PET imaging
Arm Title
healthy controls
Arm Type
Active Comparator
Arm Description
healthy adults to serve as controls and to undergo the same study procedures: CT imaging, functional PET imaging
Intervention Type
Other
Intervention Name(s)
CT imaging, functional PET imaging
Intervention Description
Physiology study using CT and functional PET imaging with 13NN and 11CO as radiotracers; images obtained before and after administration of inhaled nitric oxide and balance 80% oxygen as pulmonary vasodilators
Primary Outcome Measure Information:
Title
Coefficient of variation of perfusion
Description
Images will be generated with positron emission tomography that will be used to calculate the degreee to which the blood flow in the lung is patchy rather than smooth. The statistical measure of this is called the coefficient of variation.
Time Frame
One imaging visit lasting up to 3 hours
Secondary Outcome Measure Information:
Title
Vascular compliance
Description
Positron emission tomography images will be obtained during different phases of the heart beat that will show how the blood vessels in the lung stretch with ejection of blood from the heart. The change in volume of the blood vessels is called vascular compliance and is a measure of blood vessel stiffness.
Time Frame
One imaging visit lasting up to 3 hours
Title
Perfusion gradient
Description
From the images of blood flow in the lung, the change in mean blood flow from the bottom of the lung to the top will be calculated. Normally, there is more blood flow at the bottom of the lung compared to the top, but this can be changed with lung disease.
Time Frame
One imaging visit lasting up to 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: General A signed and dated written informed consent is obtained from the subject. The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Available to complete the study. Able to lie flat and able to perform a 30 second breath hold. Patients with Pulmonary Hypertension Subject is male or female aged = or > 18 years of age and < or = 70 years. Subject is diagnosed with pulmonary arterial hypertension (WHO Group I, by right heart catheterization, mean PA pressure > 25 and PCWP < 15) or exercise-induced pulmonary hypertension (by right heart catheterization + Level III cardiopulmonary exercise testing, mean PAP > 30 and PCWP < 20 during exercise, but normal at rest), with the most recent of above diagnostic tests taking place within 12 months of study entry. If patient has been on PAH-specific therapy, the therapy (agent and dose) has been unchanged for at least 3 months. Exclusion Criteria: General FEV1 and/or TLC < 70% predicted PCWP > 15 mm Hg Inability to perform the study (by primary MD or investigator assessment) Subjects who have a past or present disease, which as judged by the Investigators may affect the outcome of this study The subject has suspected history of drugs or alcohol abuse within the six months prior to the screening visit. The subject has a positive pregnancy test. The subject is unable to perform the respiratory manoeuvres necessary for the exam. The subject has been exposed to a radiation dose over the past year that, when added to the radiation dose expected in this study, would exceed permissible yearly exposure as determined by the MGH radiation safety committee. Subjects with Pulmonary Hypertension Subject with clinical instability in the judgment of the investigator, or hospitalization for progression of pulmonary hypertension or right heart failure in the three months prior to the study. Subjects in whom PAH therapy has been escalated (additional agent started) within 3 months of enrolment. Subject with diagnosis of active tuberculosis, lung cancer, clinically overt bronchiectasis, allergic rhinitis, asthma, or COPD. Subject that had a respiratory tract infection in the 4 weeks prior to the screening visit and throughout the duration of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. Scott Harris, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Evaluation of Pulmonary Perfusion Heterogeneity and Compliance in Patients With Pulmonary Hypertension Using Positron Emission Tomography Imaging

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