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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Functional Liver Imaging With Sulfur Colloid SPECT/CT in Primary and Metastatic Liver Cancer Patients Receiving Liver-Directed Treatment: A Pilot Study

Conditions
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Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, Stage IV Liver Cancer, Stage IVA Liver Cancer, Stage IVB Liver Cancer, Vascular Thrombosis

Intervention / Treatment
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* Procedure: Computed Tomography
* Procedure: Single Photon Emission Computed Tomography
* Drug: Technetium Tc-99m Sulfur Colloid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (SC SPECT/CT)<br>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. An additional IV contrast enhanced CT scan (70 second delay) will be obtained immediately following the SPECT/CT scan for all 3 SPECT/CT scans. | Procedure: Computed Tomography<br>* Undergo SC SPECT/CT<br>* Other names: tomography;Procedure: Single Photon Emission Computed Tomography<br>* Undergo SC SPECT/CT<br>* Other names: Tomography, Emission-Computed, Single-Photon;Drug: Technetium Tc-99m Sulfur Colloid<br>* Given IV<br>* Other names: Technetium Tc 99m Sulfur Colloid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in sulfur colloid uptake in single photon emission computed tomography/computed tomography imaging | Post-treatment changes in sulfur colloid uptake on single photon emission computed tomography/computed tomography imaging will be correlated with changes in clinical liver function. Relative changes in the parameters identified at baseline will be tested for correlation to changes in clinical liver function, including Child-Turcotte-Pugh score and albumin-bilirubin grade, as well as their individual constituents. | Baseline to last sulfur colloid single photon emission computed tomography/computed tomography, assessed up to 1 month | 
| Sulfur colloid (SC) uptake on single photon emission computed tomography/computed tomography (SPECT/CT) imaging | To characterize whole-organ liver function, all pre-treatment SPECT/CT images will be analyzed for 1) ratios of maximum, mean, and total liver SC uptake relative to spleen SC uptake (L/S) and 2) volumetric SC parameters such as the functional liver volume formed by 58% maximum image intensity threshold segmentation. Optimal image thresholds for SC SPECT parameter association to Child-Turcotte-Pugh classification (A versus B/C class) will be interrogated by receiver-operator characteristic (ROC) analysis. Image thresholds that yield maximum area under the curve in quantitative parameters such a | Up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in sulfur colloid uptake in single photon emission computed tomography/computed tomography imaging | The images will be processed similarly to the primary endpoints. Regional functional liver changes from scatter, collimator, and attenuation-corrected single photon emission computed tomography/computed tomography images will be modeled as a function of regional radiation dose. Three types of dose-response models will be defined to predict changes in liver function status. | From the second sulfur colloid single photon emission computed tomography/computed tomography scan to the third scan, assessed up to 1 month |