FDG Uptake and Lung Blood Flow in PAH Before and After Treatment With Ambrisentan

NCT02958358 | Withdrawn

• 1 other identifier: 2013P002592
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are doing this research study to find out how blood flow changes in the lungs of people with pulmonary hypertension before and after treatment with ambrisentan (sold under the brand name Letairis). The investigators hope that knowing about these differences will help us to better understand pulmonary hypertension and find new ways to diagnose it earlier.

Conditions

Pulmonary Arterial Hypertension

Keywords

pulmonary hypertension; ambrisentan; PET imaging; CT/PET

Outcome Measures

Primary Outcomes (1)

• Coefficient of variation of perfusion

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

  One imaging visit lasting up to 3 hours

Secondary Outcomes (1)

• FDG Uptake Rate (Ki)

  One imaging visit lasting up to 3 hours

Study Arms (1)

Pulmonary Hypertension

EXPERIMENTAL

Patients with Group I pulmonary arterial hypertension to undergo CT imaging, functional PET imaging before and after 3 months of treatment with ambrisentan

Other: CT imaging, functional PET imaging

Interventions

CT imaging, functional PET imaging OTHER

Physiology study using CT and functional PET imaging with 13NN and FDG as radiotracers; images obtained before and 3 months after treatment with ambrisentan.

Pulmonary Hypertension

Eligibility Criteria

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

You may qualify if:

• 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 (RHC), mean PA pressure \> 25 and PCWP \< 15) and planning to start therapy with ambrisentan, either as de-novo monotherapy or as part of combination therapy.
• Subject has most recently undergone RHC within three months of entering the study.
• If patient has been on PAH-specific therapy, the therapy (agent and dose) has been unchanged for at least three months.
• 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 fast for 6 hours prior to 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.
• PCWP \> 15 mm Hg.
• Inability to perform the study (by primary MD or investigator assessment).
• The subject is unable to perform the respiratory maneuvers necessary for the exam.
• Subjects who have diabetes mellitus or glucose intolerance.
• Subjects who have a known contraindication to ambrisentan.
• 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, or 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

• Robert Scott Harris, M.D.: lead
• Gilead Sciences: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert S Harris, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Physician, Massachusetts General Hospital, Associate Professor, Harvard Medical School

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: November 8, 2016
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 15, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)