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Completed

NCT Number: NCT02114047

Pulmonary Perfusion Heterogeneity in Patients With CTEPH Using Functional PET Imaging

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • FEV1 and/or TLC < 70% predicted.
  • Inability to perform the study (by primary MD or investigator assessment).
  • Inability to perform the respiratory maneuvers necessary for the exam.
  • 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 is a woman of childbearing potential who is pregnant, seeking to become pregnant, or has a positive pregnancy test.
  • 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.
  • Subject with diagnosis of active tuberculosis, lung cancer, clinically overt bronchiectasis, allergic rhinitis, asthma, heart failure, ischemic heart disease, 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.
  • 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.

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Evaluation of Pulmonary Perfusion Heterogeneity in Patients With Chronic Thromboembolic Pulmonary Hypertension Using Functional PET Imaging

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 15, 2014
Registry last updated
Mar 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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