Pulmonary Perfusion Heterogeneity in Patients With CTEPH Using Functional PET Imaging

NCT02114047 | Completed

• 1 other identifier: 2013D002300
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• perfusion heterogeneity

  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.

  4 months

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chronic thromboembolic pulmonary hypertension

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Officials

• Robert S Harris, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 15, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 23, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)