Clinical trial NCT02899533: [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 (PAH)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pulmonary Arterial Hypertension
Keywords: PAH
Pulmonary hypertension
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Post-menopausal women 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.

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. \< 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-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")

Primary outcomes:
measure: Evaluate [18F]FES uptake in patients with Pulmonary Arterial Hypertension (PAH) before and after initiation of fulvestrant.
timeFrame: Change from Baseline [18F]FES uptake at 9 weeks.
Secondary outcomes:
measure: FES uptake and change with treatment
timeFrame: baseline
measure: Change in FES compared to change in hematopoietic progenitor cells
timeFrame: 2 years
measure: Change in FES compared to change in hormone levels
timeFrame: 2 years
measure: Change in FES compared to change in NT-proBNP
timeFrame: 2 years
measure: Change in FES compared to change in plasma biomarkers
timeFrame: 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: David Mankoff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: