Integrated Imaging Strategy to Phenotype Progression of Liver Tumors During and After Chemoembolization
Condition: Liver Cancer; Liver Neoplasm; Hepatocellular Carcinoma; HCC
MeSH terms: Liver Neoplasms
Intervention: [18F] FMISO
Intervention description: [18F] Fluromisonidazole, 1 h-(3-[18F]-fluro-2hydroxyl-propy10-2-nitro-imidazaole is an investigational positron emission tomography (PET) radiopharmaceutical for injection and used to visualize hypoxia imaging agent. Each patient will receive up to 10 mCi of [18F] FMISO PET imaging post TACE procedure.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Cross-Sectional Imaging; Chemoembolization; Radiation Therapy; Tumor Hypoxia; PET Imaging

Summary:

      Background:

      - Treatment for liver cancer can include surgery, transplant, and chemotherapy. It can also
      include other minimally invasive tumor treatments such as transarterial chemoembolization
      (TACE). TACE treatment for liver cancer helps control the cancer but is not considered a
      cure. Researchers want to learn more about the effects of TACE on liver tumors and
      surrounding tissue. To do this, they will use a positive emission test (PET) and a
      radioactive tracer called [18F] FMISO.

      Objectives:

      - To see if [18F] FMISO is useful for evaluating what happens to liver tumors and surrounding
      tissue after TACE.

      Eligibility:

      - People age 18 and older with liver cancer who have been approved to have TACE.

      Design:

        -  Participants will meet with a study researcher to see if they can take part in the
           study.

        -  Participants will have TACE under a separate NCI protocol or at a hospital other than
           the NIH Clinical Center.

        -  Before and after TACE, participants will have a CT and MRI of the abdomen. For these
           scans, they will lie in a machine that takes pictures of their body. They will also have
           blood tests and a physical exam.

        -  The [18F] FMISO imaging study will be performed at NIH only.

        -  Participants will have an intravenous catheter placed in their arm (if they do not have
           one). The [18F] FMISO tracer will be injected.

        -  Participants will have PET-CT scans. Each scan will take about 30 minutes.

        -  Some participants will also have [18F] FMISO and PET-CT scans before TACE.

        -  As part of standard care for TACE, participants will have CT and MRI scans at regular
           intervals. This will evaluate tumor response.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

          -  Patients must have confirmed inoperable primary hepatic malignancy or hepatic dominant
             metastatic - neoplastic disease evidenced by histology or cytology, or characteristic
             enhancement pattern on CT or MRI together with an abnormal serum alpha-fetoprotein
             >200mg/dl in the case of hepatocellular carcinoma.

          -  Patients with hepatocellular carcinoma should conform to intermediate stage disease
             according to the BCLC(16) staging system (Stage A4 or B) and be otherwise eligible to
             receive TACE treatment.

          -  Patients must have had no chemotherapy or radiotherapy to the liver therapy for, their
             malignancy for at least 2 weeks (or until response can be adequately assessed) prior
             to treatment and must have recovered from all clinically significant side effects of
             therapeutic and diagnostic interventions.

          -  Serum creatinine less than or equal to 2.0 mg/dl unless the measured creatinine
             clearance is greater than 60ml/min

          -  Age greater than or equal to18 years

          -  Ability of subject to understand and willingness to sign a written informed consent
             document

          -  Patient must be able to lie still for the procedure

          -  ECOG status less than or equal to 2

          -  In addition, for patients receiving TACE outside NIH:

               -  Patient must have physician willing to collaborate with NIH PI by providing
                  required medical record and digital MR/ CT scan documentation pre and post TACE
                  procedure.

               -  Patient must be willing to sign an Authorization for the Release of Medical
                  Information form

        EXCLUSION CRITERIA:

          -  Patients who have received prior TACE treatment

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to misonidazole or other agents used in study.

          -  Patients with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events.

          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  Patients of childbearing age must not be pregnant. The effects of [(18)F]FMISO on the
             developing human fetus are unknown. Pregnancy is a contraindication for TACE.