18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant

Brief Title

18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant

Official Title

PET Imaging of Hepatocellular Carcinoma With 18F-FSPG

Brief 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.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To evaluate the relationship between 18F-FSPG PET/computed tomography (CT), pathology, and
      cancer metabolism in patients with suspected hepatocellular carcinoma (HCC) scheduled for
      liver resection surgery and orthotopic liver transplant (OLT).

      II. To compare 18F-FSPG PET/CT with standard-of-care (SOC) diagnostic MRI imaging in patients
      with suspected HCC scheduled for liver resection surgery or OLT.

      III. To compare the uptake of 18F-FSPG PET/CT with 11C-acetate PET/CT AND 18F-FDG PET/CT in
      suspected HCC and background liver in patients scheduled for liver resection surgery or OLT.

      IV. To evaluate uptake of 18F-FSPG PET/CT in benign liver lesions compared to background.

      V. To evaluate uptake of 18F-FSPG PET/CT in malignant non-HCC liver tumors.

      OUTLINE:

      Patients undergo 18F-FSPG PET and either carbon-11 (11C)-acetate PET or 18F-FDG PET scans
      within 4 weeks of surgery or OLT.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

18F-FSPG PET standardized uptake value (SUV)

Secondary Outcome

 Metabolic profile

Condition

Adult Hepatocellular Carcinoma

Intervention

Fluorine F 18 L-glutamate Derivative 18F-FSPG

Study Arms / Comparison Groups

 Diagnostic (18F-FSPG PET)

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

80

Start Date

February 15, 2022

Completion Date

May 31, 2025

Primary Completion Date

May 31, 2024

Eligibility Criteria

        Inclusion Criteria:

          1. Diagnosis of HCC with one or more of the following:

               1. 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).

               2. Suggestive imaging findings plus AFP > 200 mg/dL; or

               3. Tumor confirmed by arteriography. or

          2. Diagnosis of a benign liver tumor with the following characteristics:

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

               2. Prior SOC MRI of the benign liver lesion within 4 weeks of enrollment

             or

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

               1. Liver mass (>= 1 cm) that is biopsy proven metastatic disease (metastatic
                  colorectal cancer, metastatic pancreatic cancer).

               2. Liver mass (>= 1 cm) that is a non-HCC primary malignancy (cholangiocarcinoma).

               3. Prior SOC MRI of the malignant non-HCC liver tumor within 4 weeks of enrollment

        and

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

        and

        4. Patients with HCC or cholangiocarcinoma must be a candidate for liver resection or
        orthotopic liver transplant (OLT)

        Exclusion Criteria:

          1. Patients under the age of 18 will be excluded from this study.

          2. Patients who have HCC or cholangiocarcinoma but are not candidates for liver resection
             surgery or OLT

          3. Patients with a known prior malignancy who have received systemic chemotherapy within
             five years. Basal cell carcinoma of the skin, carcinoma in situ of the cervix, prior
             HCC, and patients with liver mass(es) proven to be metastatic disease are not
             excluded.

          4. Pregnant and breastfeeding patients.

          5. Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200
             mg/dL).

          6. Patients with a known Infiltrative variant of HCC.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Lesley Flynt, MD, 713-745-8760, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT02379377

Organization ID

2020-1084

Secondary IDs

NCI-2015-00184

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Lesley Flynt, MD, Principal Investigator, M.D. Anderson Cancer Center

Verification Date

September 2022