NCT02899533

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2021

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

4.8 years

First QC Date

August 2, 2016

Last Update Submit

May 13, 2021

Conditions

Pulmonary Arterial Hypertension

Keywords

PAHPulmonary hypertension

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • FES uptake and change with treatment

    baseline

  • Change in FES compared to change in hematopoietic progenitor cells

    2 years

  • Change in FES compared to change in hormone levels

    2 years

  • Change in FES compared to change in NT-proBNP

    2 years

  • Change in FES compared to change in plasma biomarkers

    2 years

Study Arms (1)

FES PET/CT scan

All subjects will receive an \[18F\]FES PET/CT scan.

Drug: [18F] FES

Interventions

[18F] FESDRUG

\[18F\] FES PET/CT scan, imaging tracer

Also known as: [18F]fluoroestradiol
FES PET/CT scan

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales only
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Post-menopausal women with Pulmonary Arterial Hypertension

You may qualify if:

  • \. Women who are post-menopausal, defined as one of the following
  • \> 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
  • \< 50 years and follicle-stimulating hormone levels \> 40 IU/L at screening OR
  • history of bilateral oophorectomy per medical record review or self-report.
  • \. Diagnosis of Pulmonary Arterial Hypertension (PAH) per medical record review.
  • \. 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")
  • \. 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.

You may not qualify if:

  • \. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
  • \. 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.
  • \. 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")

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial HypertensionHypertension, Pulmonary

Interventions

16-fluoroestradiol

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • David Mankoff, MD, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

September 14, 2016

Study Start

July 1, 2016

Primary Completion

April 6, 2021

Study Completion

April 6, 2021

Last Updated

May 18, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)