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Recruiting • Phasen NA • Stufe IV • ER positiv • Post-Menopausal • Interventionell

Folgendes wird aus ClinicalTrials.gov importiert:

[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE Trial

This protocol is a companion imaging study that will add FES-PET/CT imaging to the FORESEE trial at HCI. This study will establish the feasibility of using FES-PET/CT imaging to guide therapeutic decision making for functional precision oncology trials. The unique ability of FES-PET/CT to show absence of functional estrogen receptors throughout the entire body may improve confidence among research oncologists that an ER+ metastatic breast cancer patient is truly refractory to hormonal therapies which is a critical determination in the study design of the FORESEE trial.

Breast Cancer

Studiendesign
Studientyp:

Interventional

Geschätzte Einschreibung:

6 Teilnehmer

Aktueller Studienbeginn:

31. März 2021

Zulassungskriterien
Alter für die Studie berechtigt:

18 - 999

Geschlechter für die Studie berechtigt:

both


Arms and Intervention
  • [18F]Fluoroestradiol (FES) PET/CT

Einschlusskriterien
  • adults aged 18 years or greater.

  • all patients or legal guardians are willing and able to sign written informed consent and hipaa authorization in accordance with local and institutional guidelines.

  • enrolled on the foresee trial.

  • biopsy proven estrogen receptor positive breast cancer.

  • patient deemed refractory to all combinations of hormonal therapies by foresee trial investigators.

Ausschlusskriterien
  • patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. patients with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator's discretion.

  • patients who require monitored anesthesia for pet/ct scanning.

  • patients who are too claustrophobic to undergo pet/ct scanning.

  • patients who are pregnant or currently breast feeding.

  • any patient that is medically unstable defined as a patient requiring inpatient hospitalization or needing evaluation at an acute care or urgent care facility at the time of imaging.

Trial Information at Site
Last Updated:
Studieninformationen
ClinicalTrial.gov ID:

Recruiting

Estimated Enrollment:

6

Last Updated:

05/04/2024


Trial Contact

Paige Nielsen

paige.nielsen@hci.utah.edu

801-585-5942


Matthew Covington, MD

matthew.covington@hsc.utah.edu

801-585-5942


Hauptermittler

Matthew Covington, MD


Studiensponsor

University of Utah

Study Location (1)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States

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