This pilot trial studies how well single photon emission computed tomography (SPECT)/computed tomography (CT) with technetium Tc-99m sulfur colloid works in measuring liver function in patients with liver cancer that has or has not spread to other place in the body who are undergoing radiation therapy or surgery. Diagnostic procedures, such as sulfur colloid SPECT/CT scans, may measure normal liver tissue before, during and after treatment and help doctors plan better treatment for liver cancer patients.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02881554.
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.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorSmith Apisarnthanarax
