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[18F]FES PET/CT in PAH

Descriptive Information
Brief Title † [18F]FES PET/CT in PAH
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 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 Phase Phase 1
Study Type † Interventional
Study Design †
Primary Outcome Measure † Evaluate [18F]FES uptake in patients with Pulmonary Arterial Hypertension (PAH) before and after initiation of fulvestrant.
Secondary Outcome Measure † Evaluate baseline [18F]FES PET/CT uptake and change in uptake with fulvestrant in patients with PAH as a predictor of treatment response.
Condition † Pulmonary Arterial Hypertension
Intervention † Drug[18F] FES
Study Arms / Comparison Groups FES PET/CT scan All subjects will receive an [18F]FES PET/CT scan.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 10
Start Date † July 2016
Completion Date August 2018
Primary Completion Date July 2018
Eligibility Criteria † Inclusion Criteria: - 1. Women who are post-menopausal, defined as one of the following 1. > 50 years old and a) have not menstruated during the preceding 12 months per medical record review or self-report or b) have follicle-stimulating hormone levels > 40 IU/L at screening OR 2. 40 IU/L at screening OR 3. history of bilateral oophorectomy per medical record review or self-report. 2. Diagnosis of Pulmonary Arterial Hypertension (PAH) per medical record review. 3. Patients must be candidates to receive treatment on the companion therapeutic trial "Estrogen Receptor-α Inhibitor in Patients with Pulmonary Arterial Hypertension (ERA PAH)" (IRB# 824861 "ERA PAH") 4. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures. Exclusion Criteria: - 1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician 2. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study. 3. Ineligible for the therapeutic trial IRB# 824861 "ERA PAH" entitled "Estrogen Receptor Antagonist in Patients with Pulmonary Arterial Hypertension (ERA PAH)" (IRB# 824861 "ERA PAH")
Gender Female
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Karen Palmer, 215-746-2813, karen.palmer@uphs.upenn.edu
Location Countries † United States
Administrative Information
NCT ID † NCT02899533
Organization ID 824918
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † University of Pennsylvania
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date March 2017
First Received Date † August 2, 2016
Last Updated Date March 15, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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