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Pulmonary Perfusion Heterogeneity in Patients With CTEPH Using Functional PET Imaging

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ClinicalTrials.gov Identifier: NCT02114047
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
Robert Scott Harris, M.D., Massachusetts General Hospital

Brief Summary:
This study with evaluate blood flow in the lungs of patients prior to and after surgery for treatment.

Condition or disease
Chronic Thromboembolic Pulmonary Hypertension

Detailed Description:
Specifically, we will evaluate the length-scale or size of blood flow alterations using filtering techniques with the objective of identifying the size of blood vessels that are obstructed by clot (large vessels versus small vessels).

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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of Pulmonary Perfusion Heterogeneity in Patients With Chronic Thromboembolic Pulmonary Hypertension Using Functional PET Imaging
Study Start Date : February 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017





Primary Outcome Measures :
  1. perfusion heterogeneity [ Time Frame: 4 months ]
    We will use a method to analyze the length-scale of perfusion heterogeneity before and after surgery for CTEPH. Briefly, this method consists of filtering the images with filters of different spatial size (length, mm) and measuring the coefficient of variation (CV) of perfusion in the imaged field. We then bin the CV into the following intervals: 12-36 mm, 36-60 mm, 60-84 mm, 84-108 mm and >108 mm and compare the CV in each bin among subjects.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chronic thromboembolic pulmonary hypertension
Criteria

Inclusion Criteria:

  1. Subject is diagnosed with chronic thromboembolic pulmonary hypertension (WHO Group IV) and planning to undergo pulmonary thromboendarterectomy.
  2. Subject is male or female aged > or =18 years of age and < or = 70 years.
  3. Subject has undergone RHC within six months of entering the study.
  4. The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  5. A signed and dated written informed consent is obtained from the subject.
  6. Available to complete the study.
  7. Able to lie flat and able to perform a 30 second breath hold.

Exclusion Criteria:

  1. FEV1 and/or TLC < 70% predicted.
  2. Inability to perform the study (by primary MD or investigator assessment).
  3. Inability to perform the respiratory maneuvers necessary for the exam.
  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 is a woman of childbearing potential who is pregnant, seeking to become pregnant, or has a positive pregnancy test.
  7. Subject with clinical instability in the judgment of the investigator, with a heart rate > 120 bpm, respiratory rate > 24, SpO2 < 88%, blood pressure < 90/60 or > 140/90 or fever > 101, or subjects with hospitalization for progression of pulmonary hypertension or right heart failure in the three months prior to the study.
  8. Subject with diagnosis of active tuberculosis, lung cancer, clinically overt bronchiectasis, allergic rhinitis, asthma, heart failure, ischemic heart disease, or COPD.
  9. Subject that had a respiratory tract infection in the 4 weeks prior to the screening visit and throughout the duration of the study.
  10. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114047


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Robert S Harris, MD Massachusetts General Hospital

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Responsible Party: Robert Scott Harris, M.D., Associate Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02114047    
Other Study ID Numbers: 2013D002300
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Since imaging data can be identifying, researchers will need to write to the investigators and submit to IRB review if they would like to obtain raw imaging data.
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases