Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-08 @ 9:42 AM
Study NCT ID:
NCT02899533
Status:
TERMINATED
Last Update Posted:
2021-05-18
First Post:
2016-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
[18F]FES PET/CT in PAH
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
[18F]Fluoroestradiol (FES) PET/CT 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 (PET/CT) imaging will be used to evaluate evaluation of estrogen receptor heterogeneity and functionality in Pulmonary Arterial Hypertension (PAH) using the investigational radiotracer \[18F\]fluoroestradiol (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 \[18F\]FES PET/CT scans for this protocol. A baseline FES PET/CT will occur on Day 0 (-2 days) of the companion treatment trial prior to initiation of fulvestrant. The second FES PET/CT 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:
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?: