PET Imaging of Hepatocellular Carcinoma With 18F-FSPG

Who is this study for? Patients with hepatocellular carcinoma
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Biological, Other
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This clinical trial studies fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) positron emission tomography (PET) in imaging patients with liver cancer before undergoing surgery or transplant. Diagnostic procedures, such as 18F-FSPG PET, may help find and diagnose liver cancer and find out how far the disease has spread.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of HCC with one or more of the following:

‣ Liver mass with non-rim arterial phase hyperenhancement (APHE) and one of the following: 1) 10-19 mm with ≥2 additional major features according to LI-RADS criteria (washout, enhancing capsule, and/or threshold growth), 2) 10-19 mm with washout and visibility at antecedent ultrasound (US) but with no capsule or threshold growth, 3) 10-19 mm with ≥50% size increase in ≤6 months but with no washout or capsule or 4) ≥20 mm with ≥1 additional major feature according to LI-RADS criteria (washout, enhancing capsule, or threshold growth).

⁃ Lesions that meet LI-RADS 4 criteria or

⁃ Suggestive imaging findings plus AFP \> 200 mg/dL or

⁃ Tumor confirmed by arteriography or

⁃ Pathologic confirmation of tumor or

• Diagnosis of a benign abdominal or pelvic tumor with the following characteristics:

‣ Liver mass (≥ 1 cm) that has suggestive imaging findings of a benign liver mass (adenoma, hemangioma, focal nodular hyperplasia).

⁃ Prior SOC MRI or CT of the benign lesion within 8 weeks of enrollment or

• Diagnosis of a malignant non-HCC liver tumor with one or more of the following characteristics:

‣ Liver mass (≥ 1 cm) that is biopsy proven, MRI-confirmed, or CT-confirmed metastatic disease (metastatic colorectal cancer, metastatic pancreatic cancer).

⁃ Liver mass (≥ 1 cm) that is a non-HCC primary malignancy (cholangiocarcinoma).

⁃ Prior SOC MRI or CT of the malignant non-HCC liver tumor within 8 weeks of enrollment or

• Diagnosis of oligometastatic solid tumors in the following disease sites: colorectal, sarcoma, lung, head and neck, ovarian, renal, melanoma, pancreatic, prostate, cervix, breast, uterine and cholangiocarcinoma undergoing local consolidative therapy.

• and

• Each patient must have completed conventional imaging and staging and MRI or CT before initiation of the investigational PET studies.

• and

• Participants with HCC must be a candidate for liver resection, orthotopic liver transplant (OLT), or Y90 radioembolization.

Locations
United States
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Simone S Krebs, MD
SSKrebs@mdanderson.org
713-563-6726
Time Frame
Start Date: 2022-02-15
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 110
Treatments
Experimental: Diagnostic (18F-FSPG PET)
Patients undergo an 18F-FSPG PET scan within 4 weeks of surgery or OLT. Patients may also receive a second 18F-FSPG PET scan following standard-of-care treatment.
Experimental: Diagnostic (11C-Acetate PET or 18F-FDG PET)
Patients may undergo either carbon-11 (11C)-Acetate PET or 18F-FDG PET scans within 4 weeks of surgery or OLT.
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov