Clinical Trial: [18F]FES PET/CT in PAH

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: [18F]Fluoroestradiol (FES) PET/CT Imaging To Evaluate In Vivo ER In Patients With Pulmonary Arterial Hypertension

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 Summary: 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.
Sponsor: University of Pennsylvania

Current Primary Outcome: Evaluate [18F]FES uptake in patients with Pulmonary Arterial Hypertension (PAH) before and after initiation of fulvestrant. [ Time Frame: Change from Baseline [18F]FES uptake at 9 weeks. ]

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.


Original Primary Outcome: Evaluate [18F]FES uptake in patients with Pulmonary Arterial Hypertension (PAH) before and after initiation of fulvestrant. [ Time Frame: baseline and 9 weeks post-therapy ]

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.


Current Secondary Outcome:

  • 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 ]
  • 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 ]
  • 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 ]
  • Correlate change in [18F]FES uptake with changes in NT-proBNP (pg/mL) after the administration of fulvestrant in PAH. [ Time Frame: 2 years ]
  • 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 ]


Original Secondary Outcome: Same as current

Information By: University of Pennsylvania

Dates:
Date Received: August 2, 2016
Date Started: July 2016
Date Completion: August 2018
Last Updated: March 15, 2017
Last Verified: March 2017