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

Not Applicable

Terminated

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

Interventions: Procedure: Computed Tomography
Procedure: Single Photon Emission Computed Tomography
Drug: Technetium Tc-99m Sulfur Colloid

Registration Number: NCT02881554

Lead Sponsor: University of Washington

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: 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: radiation 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 41

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (SC SPECT/CT)	Computed Tomography	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.
Diagnostic (SC SPECT/CT)	Single Photon Emission Computed Tomography	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.
Diagnostic (SC SPECT/CT)	Technetium Tc-99m Sulfur Colloid	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.

Primary Outcome Measures

Name	Time	Method
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Functional Liver Volume: Cohort A - Radiation	Baseline, mid-treatment at 2 weeks, and post-treatment at 1 month	Functional liver volume ratio (FLV): represents the percent of the anatomic liver which is functioning and is defined as the ratio of liver functional volume (in cc of volume) to the anatomic liver volume (in cc of volume). Since this outcome measure is a ratio, it is unitless. A higher FLV ratio reflects a higher volume of functional liver.
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Liver-to-Spleen Mean: Cohort A - Radiation	Baseline, mid-treatment at 2 weeks, and post-treatment at 1 month	Liver-to-spleen ratio (L/S mean): represents the magnitude of the global liver function and is defined as the ratio of the mean SC counts in the functional liver to the mean SC counts in the spleen. Since this outcome measure is a ratio, it is unitless. A higher L/S mean ratio reflects higher magnitude of liver function.
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Total Liver Function: Cohort A - Radiation	Baseline, mid-treatment at 2 weeks, and post-treatment at 1 month	Total liver function (TLF): represents the integral liver function and is defined by the product of the functional liver volume (FLV) ratio and liver-to-spleen (L/S) mean ratio. Since this outcome measure is a product of ratios, it is unitless. A higher TLF ratio reflects higher liver function. Median differences were estimated using Wilcoxon (Mann-Whitney) tests.
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Spatial Heterogeneity: Cohort A - Radiation	Baseline, mid-treatment at 2 weeks, and post-treatment at 1 month	To characterize spatial distribution of functional liver, the coefficient of variation (CV) within the FLV will be measured (unitless). A higher CV means more variability or heterogeneity in liver function.

Secondary Outcome Measures

Name	Time	Method
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Functional Liver Volume: Cohort B - Surgery	Baseline, perioperative (2-3 days post surgery), and postoperative (1 month post surgery)	Functional liver volume ratio (FLV): represents the percent of the anatomic liver which is functioning and is defined as the ratio of liver functional volume (in cc of volume) to the anatomic liver volume (in cc of volume). Since this outcome measure is a ratio, it is unitless. A higher FLV ratio reflects a higher volume of functional liver.
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Liver-to-Spleen Mean: Cohort B - Surgery	Baseline, perioperative (2-3 days post surgery), and postoperative (1 month post surgery)	Liver-to-spleen ratio (L/S mean): represents the magnitude of the global liver function and is defined as the ratio of the mean SC counts in the functional liver to the mean SC counts in the spleen. Since this outcome measure is a ratio, it is unitless. A higher L/S mean ratio reflects higher magnitude of liver function.
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Total Liver Function: Cohort B - Surgery	Baseline, perioperative (2-3 days post surgery), and postoperative (1 month post surgery)	Total liver function (TLF): represents the integral liver function and is defined by the product of the functional liver volume (FLV) ratio and liver-to-spleen (L/S) mean ratio. Since this outcome measure is a product of ratios, it is unitless. A higher TLF ratio reflects higher liver function. Median differences were estimated using Wilcoxon (Mann-Whitney) tests.

Trial Locations

Locations (2): Fred Hutch/University of Washington Cancer Consortium
🇺🇸
Seattle, Washington, United States
ProCure Proton Therapy Center-Seattle
🇺🇸
Seattle, Washington, United States
Fred Hutch/University of Washington Cancer Consortium
🇺🇸Seattle, Washington, United States