[18F]FES PET/CT in PAH

Pulmonary Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02899533
• Other study ID #: 824918
• Status: Terminated
• Start date: July 2016
• Est. completion date: April 6, 2021

Study information

• Verified date: May 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 6, 2021
• Est. primary completion date: April 6, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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")

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• [18F] FES
[18F] FES PET/CT scan, imaging tracer

Locations

Country	Name	City	State
United States	University of Pennsylvania Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline [18F]FES uptake at 9 weeks.
Secondary	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.	baseline
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years