[18F]FES PET/CT in PAH

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02899533
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Duration (Months): 57.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension	Drug: [18F] 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 Design

• Study Type: Observational
• Actual Enrollment: 5 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: [18F]Fluoroestradiol (FES) PET/CT Imaging To Evaluate In Vivo ER In Patients With Pulmonary Arterial Hypertension (PAH)
• Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Apr 6, 2021
• Actual Study Completion Date: Apr 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
FES PET/CT scan All subjects will receive an [18F]FES PET/CT scan.	Drug: [18F] FES; [18F] FES PET/CT scan, imaging tracer; Other Names: [18F]fluoroestradiol

Outcome Measures

Primary Outcome Measures

1. Evaluate [18F]FES uptake in patients with Pulmonary Arterial Hypertension (PAH) before and after initiation of fulvestrant. [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.

Secondary Outcome Measures

1. FES uptake and change with treatment [baseline]

   Evaluate baseline [18F]FES PET/CT uptake and change in uptake with fulvestrant in patients with PAH as a predictor of treatment response.

2. Change in FES compared to change in hematopoietic progenitor cells [2 years]

   Correlate change in [18F]FES uptake with changes in the number of circulating hematopoietic progenitor cells after the administration of fulvestrant in PAH.

3. Change in FES compared to change in hormone levels [2 years]

   Correlate change in [18F]FES uptake with changes in plasma hormone levels (pg/mL) after the administration of fulvestrant in PAH.

4. Change in FES compared to change in NT-proBNP [2 years]

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

5. Change in FES compared to change in plasma biomarkers [2 years]

   Correlate change in [18F]FES uptake with changes in other plasma biomarkers (pg/mL) after the administration of fulvestrant in PAH.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

4. Diagnosis of Pulmonary Arterial Hypertension (PAH) per medical record review.

5. 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")

6. 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

1. 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.

2. 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")

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: David Mankoff, MD, PhD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02899533
• Other Study ID Numbers: 824918
• First Posted: Sep 14, 2016
• Last Update Posted: May 18, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of Pennsylvania: PAH; Pulmonary hypertension
• Additional relevant MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension

Study Results

No Results Posted as of May 18, 2021