[18F]FES PET/CT in PAH

University of Pennsylvania

Status: Terminated

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: [18F] FES

Study type: Observational

Funder types: Other

Identifiers

NCT02899533

824918

Details and patient eligibility

About

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).

Full 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.

Enrollment: 5 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Women who are post-menopausal, defined as one of the following

  2. > 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

  3. < 50 years and follicle-stimulating hormone levels > 40 IU/L at screening OR

  4. history of bilateral oophorectomy per medical record review or self-report.

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

  6. 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")

  7. 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")

Trial design

5 participants in 1 patient group

FES PET/CT scan

Description:

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

Treatment:

Drug: [18F] FES