Pulmonary Arterial HypertensionNCT02958358
FDG Uptake and Lung Blood Flow in PAH Before and After Treatment With Ambrisentan
A study testing CT imaging, functional PET imaging in people with Pulmonary Arterial Hypertension, run by Robert Scott Harris, M.D. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- CT imaging, functional PET imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Evaluation of FDG Uptake and Pulmonary Perfusion by Positron Emission Tomography in Patients With Pulmonary Arterial Hypertension Before and After Treatment With Ambrisentan
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.
Read the detailed description
The overall goal of this study is to evaluate lung, large vessel, and right ventricular glucose uptake rate using 18FDG PET and distribution of pulmonary perfusion using 13NN PET in patients with pulmonary hypertension before and after treatment with ambrisentan. The investigators propose a pilot study of patients with Group I PAH. The investigators plan to complete this pilot study with 5 patients (projected enrollment of 8 to allow for drop-out rate). Taken together, the studies above demonstrate that FDG-PET can be used to detect changes associated with PAH, and to monitor response to therapy. FDG-PET is a widely available technology, and is firmly established in the field of clinical oncology. Ambrisentan is an endothelin receptor antagonist that is FDA-approved to treat patients with pulmonary arterial hypertension. Patients will be eligible for participation in this study if they have already made a decision to start treatment with ambrisentan for pulmonary hypertension. The investigators propose a physiologic study of patients who will already have made a decision to start ambrisentan therapy. Participation in the study will not alter or affect participants decisions regarding treatment.
Prior human studies evaluating response to PH-specific therapies focused only on the right ventricle. Oikawa et al. looked at the RV uptake in patients with PH and evaluated them before and after treatment with epoprostenol. Fang and colleagues used FDG-SPECT evaluate FDG uptake in the RV of patients with IPAH and PH before and after treatment with sildenafil. Both of those studies used SUV (specific uptake variable). The investigators propose to focus on the lung and the RV uptake rate (Ki) in order to provide a more robust analysis of the metabolic changes that underlie the development of pulmonary hypertension both in the right ventricle and the lung parenchyma, and to study the response to ambrisentan with FDG-PET.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- CT imaging, functional PET imaging
- Keywords
- pulmonary hypertension, ambrisentan, PET imaging, CT/PET
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT imaging, functional PET imagingOther
Physiology study using CT and functional PET imaging with 13NN and FDG as radiotracers; images obtained before and 3 months after treatment with ambrisentan.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: CT imaging, functional PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One imaging visit lasting up to 3 hours
Secondary outcomes (1)
FDG Uptake Rate (Ki)
To determine the FDG uptake (Ki) in the right ventricle, large pulmonary vessels, and pulmonary parenchyma to investigate the effect of treatment with ambrisentan on the RV, large vessel and pulmonary parenchyma 18FDG uptake rate and its relationship to invasive hemodynamic measurements, RV function by echo, functional class, 6MWT and serum NT-proBNP levels.
Measured: One imaging visit lasting up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startSep 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2016
Why it stopped: inability to recruit subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Scott Harris, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor-investigator, Robert Scott Harris, M.D., Massachusetts General Hospital
- Investigators
- Robert S Harris, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958358
- Sponsor's protocol ID
- 2013P002592
- Status last verified
- Nov 2016
- First submitted
- 6 Apr 2015
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: None obtained
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of FDG Uptake and Pulmonary Perfusion by Positron Emission Tomography in Patients With Pulmonary Arterial Hypertension Before and After Treatment With Ambrisentan
- ClinicalTrials.gov ID
- NCT02958358
- Acronym / sponsor ID
- 2013P002592
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- pulmonary hypertension, ambrisentan, PET imaging, CT/PET
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: inability to recruit subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Robert Scott Harris, M.D.University, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overall goal of this study is to evaluate lung, large vessel, and right ventricular glucose uptake rate using 18FDG PET and distribution of pulmonary perfusion using 13NN PET in patients with pulmonary hypertension before and after treatment with ambrisentan. The investigators propose a pilot study of patients with Group I PAH. The investigators plan to complete this pilot study with 5 patients (projected enrollment of 8 to allow for drop-out rate). Taken together, the studies above demonstrate that FDG-PET can be used to detect changes associated with PAH, and to monitor response to therapy. FDG-PET is a widely available technology, and is firmly established in the field of clinical oncology. Ambrisentan is an endothelin receptor antagonist that is FDA-approved to treat patients with pulmonary arterial hypertension. Patients will be eligible for participation in this study if they have already made a decision to start treatment with ambrisentan for pulmonary hypertension. The investigators propose a physiologic study of patients who will already have made a decision to start ambrisentan therapy. Participation in the study will not alter or affect participants decisions regarding treatment.
Prior human studies evaluating response to PH-specific therapies focused only on the right ventricle. Oikawa et al. looked at the RV uptake in patients with PH and evaluated them before and after treatment with epoprostenol. Fang and colleagues used FDG-SPECT evaluate FDG uptake in the RV of patients with IPAH and PH before and after treatment with sildenafil. Both of those studies used SUV (specific uptake variable). The investigators propose to focus on the lung and the RV uptake rate (Ki) in order to provide a more robust analysis of the metabolic changes that underlie the development of pulmonary hypertension both in the right ventricle and the lung parenchyma, and to study the response to ambrisentan with FDG-PET.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Hypertension | Experimental | Other: CT imaging, functional PET imagingPatients with Group I pulmonary arterial hypertension to undergo CT imaging, functional PET imaging before and after 3 months of treatment with ambrisentan |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT imaging, functional PET imagingPhysiology study using CT and functional PET imaging with 13NN and FDG as radiotracers; images obtained before and 3 months after treatment with ambrisentan. | Other | Pulmonary Hypertension |
Primary outcome
Coefficient of variation of perfusion
Time frame: One imaging visit lasting up to 3 hours
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.
1 secondary outcome
FDG Uptake Rate (Ki)
Time frame: One imaging visit lasting up to 3 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Individual participant dataSharing planned: No. None obtained
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S Harris, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT imaging, functional PET imaging in people with Pulmonary Arterial Hypertension, run by Robert Scott Harris, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coefficient of variation of perfusion (time frame: One imaging visit lasting up to 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.