Hepatocellular Carcinoma
Conditions
Brief summary
This is a pilot study to investigate the evaluate to use of a drug/radiopharmaceutical called Gallium-68 PSMA-11 (68Ga-PSMA-11) for use in PET/MRI evaluation of hepatocellular carcinoma
Detailed description
This is a prospective pilot proof-of-concept single-center study. Primary Objective Using surgical histopathology as the reference standard, the investigators intend to achieve the following objectives in adult subjects with Hepatocellular Carcinoma (HCC) undergoing surgical resection or transplant: 1. To demonstrate the feasibility of 68Ga-PSMA-PET/MRI for imaging patients with HCC 2. To estimate the sensitivity of SUVmax on PSMA PET for identification of LI-RADS® 5 (definitely HCC) observations or biopsy proven HCC(s). 3. To perform a Radiology-Pathology correlation of PSMA uptake at PET with HCC tumor PSMA immunostaining, tumor pathology features, and signal and enhancement characteristics at MRI
Interventions
DRUG68Ga-PSMA-11 PET/MRI
The PET/MRI exam-related patient visit will last approximately 2 to 2.5 hours, including 30-minute nursing assessment, 45-60 minutes for PSMA uptake and 60 minutes for PET/MRI scan. They will be contacted within the next 72 hours to complete a brief phone survey.
Sponsors
Ajit H. Goenka, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients at risk for HCC with either an imaging diagnosis of HCC by ceCT or ceMRI (LI-RADS 5) confirmed by a board-certified abdominal radiologist or biopsy-proven HCC confirmed by a hepatobiliary pathologist * No prior treatment for HCC * Subjects who are expected to undergo surgical resection of the hepatic lesion(s) and/or liver transplant * Male or female with age greater than 18 years, with the capacity to give informed consent and willingness to provide a written consent.
Exclusion criteria
* Subjects requiring emergent surgery for a ruptured/bleeding HCC * Bilirubin \> 3.0 mg/dL, which is a contraindication for Gadoxetate, the MRI contrast agent * Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the PET scan. * Subjects with higher than the weight/size limitations of PET/MRI scanner. * Subjects with contraindication to MRI including: Subjects who have a heart pacemaker, subjects who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain, subjects who have implanted devices with magnets, subjects who have other implanted electronic devices, subjects who have deep brain stimulator, subjects who have vagal nerve stimulator, subjects with cochlear (ear) or auditory implants * Subjects with history of allergic response to radiocontrast media * Subjects with known history of claustrophobia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of PSMA PET-MR for identification of intra and extrahepatic hepatocellular carcinoma in patients | 18 months | Sensitivity of PSMA PET-MRI for detection of LI-RADS 5 (definitely HCC) lesions on a per-lesion basis with histopathology as the gold standard. We will perform a Radiologic-pathologic correlation comparing HCC PSMA SUVmax with tumor PSMA immunostaining positivity. |
Countries
United States
Outcome results
None listed