Ignite Creation Date:
2024-05-06 @ 9:04 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02899533
Status:
TERMINATED
Last Update Posted:
2021-05-18
First Post:
2016-08-02
Brief Title:
18FFES PETCT in PAH
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
18FFluoroestradiol FES PETCT Imaging To Evaluate In Vivo ER In Patients With Pulmonary Arterial Hypertension PAH
Status:
TERMINATED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The method did not help with assessing PAH and so the trial was terminated early
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study positron emission tomography PETCT imaging will be used to evaluate evaluation of estrogen receptor heterogeneity and functionality in Pulmonary Arterial Hypertension PAH using the investigational radiotracer 18Ffluoroestradiol FES
Detailed Description:
This is a feasibility study of serial FES scanning in female patients with Pulmonary Arterial Hypertension PAH to determine whether patients have detectable changes in FES SUV following treatment with fulvestrant on the separate therapeutic protocol IRB 824861 Estrogen Receptor Antagonist in Patients with Pulmonary Arterial Hypertension ERA PAH Subjects will undergo up to 2 18FFES PETCT scans for this protocol A baseline FES PETCT will occur on Day 0 -2 days of the companion treatment trial prior to initiation of fulvestrant The second FES PETCT scan will occur on week 9 63 7 days after initiation of fulvestrant We will compare SUV values after fulvestrant to pre-treatment values
Study Oversight
Has Oversight DMC:
None
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?:
None