A Study to Evaluate 68Ga- PSMA-Dual Contrast PET/MRI and PET/CT for Hepatocellular Carcinoma

Overview

Información sobre este estudio

The purpose of this study is to evaluate the feasibility and diagnostic performance of 68Ga PSMA-dual contrast PET/MRI for detection and staging of Hepatocellular Carcinoma (HCC), and to compare it with standard-of-care (SOC) imaging. Additionally, this study aims to identify the biologic correlates of biomarkers derived from 68Ga PSMA-dual contrast PET/MRI with histopathology features and PSMA immunostaining of HCC.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

- Patients with either an imaging diagnosis of HCC by CT or MRI (Liver Imaging Reporting
and Data System [LI-RADS] 5) confirmed by a board-certified abdominal radiologist, or
with biopsy-proven HCC

- No prior treatment for HCC

- Patients who may undergo hepatic surgical resection or liver transplant

- Male or female with age greater than 18 years, with the capacity and willingness to
provide written informed consent

Exclusion Criteria:

- Patients requiring emergent surgery for a ruptured/bleeding HCC

- Bilirubin > 3.0 mg/dL, which is a contraindication for Gadoxetate, the MRI contrast
agent (relevant to PET/MRI)

- Patients with glomerular filtration rate (GFR) < 30 ml/min/1.73m^2, on dialysis, or
with acute kidney injury

- Pregnant and/or breast-feeding patients. A negative pregnancy test within 48 hours of
the PET scan

- Patients with higher than the weight/size limitations of PET/MRI or PET/CT scanner

- Subjects with history of allergic response to Eovist or Gadavist

- Subjects with known history of claustrophobia

- Subjects with GFR < 30 ml/min/1.73m^2, on dialysis, or with acute kidney injury

- Subjects with a history of severe hypersensitivity to Eovist or Gadavist

- Patients with contraindication to MRI (relevant to PET/MRI):

- Patients who have a heart pacemaker

- Patients who have a metallic foreign body (metal sliver) in their eye, or who
have an aneurysm clip in their brain

- Patients who have implanted devices with magnets

- Patients who have other implanted electronic devices

- Patients who have deep brain stimulator

- Patients who have vagal nerve stimulator

- Patients with cochlear (ear) or auditory implants

Eligibility last updated 6/30/22. Questions regarding updates should be directed to the study team contact.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Ajit Goenka, M.D.

Abierto para la inscripción

Contact information:

Kurt Kevin Degillo CCRP

(507) 422-5407

Degillo.Kurt@mayo.edu

More information

Publicaciones

Publications are currently not available
.
CLS-20508600

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