Sulfur Colloid SPECT/CT in Measuring Liver Function in Patients With Primary or Metastatic Liver Cancer Undergoing Radiation Therapy or Surgery

PRIMARY OBJECTIVES:

I. Develop new quantitative metrics of baseline technetium Tc-99m sulfur colloid (SC) uptake
on SPECT/CT imaging and correlate with clinical parameters of liver function and clinical
outcomes in liver cancer patients receiving radiation therapy (RT) or surgery.

II. Correlate post-treatment changes in SC uptake on SPECT/CT imaging with changes in
clinical liver function.

SECONDARY OBJECTIVES:

I. Estimate the dose response relationship on multiple spatial scales (global liver, regional
liver, liver image voxel) between radiation dose and changes in SC uptake, both acutely
(mid-RT) and subacutely (1 month post-RT), using SC SPECT/CT imaging.

II. Estimate the degree of radiation response in liver tissue with varying levels of function
(i.e. compare radiation dose response of well compensated livers against less compensated
livers).

III. Correlate SC uptake on SPECT/CT imaging in future liver remnant (FLR) with extent of
liver hypertrophy after surgical resection.

OUTLINE: Patients are assigned to 1 of 2 cohorts depending on which standard of care they are
receiving outside of this study, as part of their cancer treatment: RT or surgery.

All patients have a total of 3 SPECT/CT imaging with 99mTc-SC. The first scan in both cohorts
is routine medical care (not experimental) and takes place prior to initiation of RT or
surgery. Two follow up scans are part of the protocol.

COHORT A (patients receiving radiation therapy per standard cancer treatment): The first
follow up scan occurs at mid-RT, and the second one at 1 month post-RT.

COHORT B (patients undergoing surgery per standard cancer treatment): The first follow-up
scan occurs 3-5 days postoperatively, and the second one at 1 month post-operatively. An
additional intravenous (IV) contrast enhanced CT scan (70 second delay) will be obtained
immediately following the SPECT/CT scan for all 3 SPECT/CT scans.

After completion of study, patients are followed up at 6 months.

Inclusion Criteria:

- Patients with a diagnosis of hepatocellular carcinoma (HCC), intrahepatic
cholangiocarcinoma, or metastatic liver cancer planned to receive definitive doses of
radiation or surgical resection are eligible

- Measurable hepatic disease and/or presence of vascular tumor thrombosis

- Diagnostic CT or magnetic resonance imaging (MRI) scan within 2 months of study entry

- There are no limits on prior therapy; patients are allowed to have prior systemic
therapy, radiation therapy, radiofrequency ablation, catheter-based therapies, and
surgery; patients are allowed to have concurrent chemotherapy with radiation treatment

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients unable to tolerate a SPECT/CT 99mTc-SC scan

- Patients who are not planning to adhere to the required follow up schedule as outlined
in this protocol

- Pregnant women

- Women of childbearing potential and men who are sexually active and not willing/able
to use medically acceptable forms of contraception

- Patients unable to provide informed consent