An observational study in Pulmonary Arterial Hypertension, sponsored by University of Pennsylvania. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-18.
Sponsored by University of Pennsylvania · Observational
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).
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.
761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.
This study's enrollment of 5 is below the median of 100 across 197 observational studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Post-menopausal women with Pulmonary Arterial Hypertension
Women who are post-menopausal, defined as one of the following
Exclusion Criteria:
Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
All subjects will receive an \[18F\]FES PET/CT scan.
Drug: [18F] FES
\[18F\] FES PET/CT scan, imaging tracer
Also known as: [18F]fluoroestradiol
Evaluate [18F]FES uptake in patients with Pulmonary Arterial Hypertension (PAH) before and after initiation of fulvestrant.
Patients will have a baseline FES PET/CT scan prior to the initiation of fulvestrant and a second FES PET/CT scan 9 weeks after the initiation of fulvestrant.
Time frame: Change from Baseline [18F]FES uptake at 9 weeks.
FES uptake and change with treatment
Evaluate baseline \[18F\]FES PET/CT uptake and change in uptake with fulvestrant in patients with PAH as a predictor of treatment response.
Time frame: baseline
Change in FES compared to change in hematopoietic progenitor cells
Correlate change in \[18F\]FES uptake with changes in the number of circulating hematopoietic progenitor cells after the administration of fulvestrant in PAH.
Time frame: 2 years
Change in FES compared to change in hormone levels
Correlate change in \[18F\]FES uptake with changes in plasma hormone levels (pg/mL) after the administration of fulvestrant in PAH.
Time frame: 2 years
Change in FES compared to change in NT-proBNP
Correlate change in \[18F\]FES uptake with changes in NT-proBNP (pg/mL) after the administration of fulvestrant in PAH.
Time frame: 2 years
Change in FES compared to change in plasma biomarkers
Correlate change in \[18F\]FES uptake with changes in other plasma biomarkers (pg/mL) after the administration of fulvestrant in PAH.
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Pulmonary Arterial Hypertension→
University of Pennsylvania