Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT02958358
Status:
WITHDRAWN
Last Update Posted:
2016-11-15
First Post:
2015-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FDG Uptake and Lung Blood Flow in PAH Before and After Treatment With Ambrisentan
Sponsor:
Robert Scott Harris, M.D.
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
inability to recruit subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: