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

Descriptive Information
Brief Title † Sulfur Colloid SPECT/CT in Measuring Liver Function in Patients With Primary or Metastatic Liver Cancer Undergoing Radiation Therapy or Surgery
Official Title † Functional Liver Imaging With Sulfur Colloid SPECT/CT in Primary and Metastatic Liver Cancer Patients Receiving Liver-Directed Treatment: A Pilot Study
Brief Summary 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.
Detailed Description 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. After completion of study, patients are followed up at 6 months.
Study Phase N/A
Study Type † Interventional
Study Design †
Primary Outcome Measure † Changes in SC uptake in SPECT/CT imaging
Secondary Outcome Measure † Changes in SC uptake in SPECT/CT imaging
Condition † Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma Stage IV Liver Cancer Stage IVA Liver Cancer Stage IVB Liver Cancer Vascular Thrombosis
Intervention † ProcedureComputed Tomography
Study Arms / Comparison Groups Diagnostic (SC SPECT/CT) There are 2 cohorts of patients: Those receiving radiation therapy per standard of care (Cohort A) and those undergoing surgery per standard of care (Cohort B). 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. In cohort A, the first follow up scan occurs at mid-RT, and the second one at 1 month post-RT. In cohort B, the first follow-up scan occurs 3-5 days postoperatively, and the second one at 1 month post-operatively.
Publications *

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

Recruitment Information
Recruitment Status † Procedure
Estimated Enrollment † 60
Start Date † December 21, 2016
Completion Date
Primary Completion Date June 1, 2022
Eligibility Criteria † 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
Gender All
Ages 19 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT02881554
Organization ID 9646
Secondary IDs †† NCI-2016-01198, 9646, P30CA015704
Responsible Party Sponsor
Study Sponsor † University of Washington
Collaborators †† National Cancer Institute (NCI)
Investigators † Principal Investigator: Smith Apisarnthanarax, Fred Hutch/University of Washington Cancer Consortium
Information Provided By
Verification Date March 2017
First Received Date † August 23, 2016
Last Updated Date March 30, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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