[18F]FES PET/CT in PAH

• Register: ClinicalTrials.gov
• Last refreshed on: 24 May 2021
• Main ID: NCT02899533
• Date of registration: 02/08/2016
• Prospective Registration: No
• Primary sponsor: University of Pennsylvania
• Public title: [18F]FES PET/CT in PAH
• Scientific title: [18F]Fluoroestradiol (FES) PET/CT Imaging To Evaluate In Vivo ER In Patients With Pulmonary Arterial Hypertension (PAH)
• Date of first enrolment: July 2016
• Target sample size: 5
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02899533
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: David Mankoff, MD, PhD
• Affiliation: University of Pennsylvania

Key inclusion & exclusion 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. < 50 years and follicle-stimulating hormone levels > 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-a 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")



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: [18F] FES

Primary Outcome(s)

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.]

Secondary Outcome(s)

Change in FES compared to change in hormone levels [Time Frame: 2 years]

Change in FES compared to change in plasma biomarkers [Time Frame: 2 years]

FES uptake and change with treatment [Time Frame: baseline]

Change in FES compared to change in hematopoietic progenitor cells [Time Frame: 2 years]

Change in FES compared to change in NT-proBNP [Time Frame: 2 years]

Secondary ID(s)

824918

Source(s) of Monetary Support

Please refer to primary and secondary sponsors