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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01198 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 9646 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| RG3116003 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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Terminated due to low accrual in Cohort B. (Accrual goal for Cohort A was met.)
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (SC SPECT/CT) | Experimental | 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo SC SPECT/CT |
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| Measure | Description | Time Frame |
|---|---|---|
| Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Functional Liver Volume: Cohort A - Radiation | 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. | Baseline, mid-treatment at 2 weeks, and post-treatment at 1 month |
| Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Liver-to-Spleen Mean: Cohort A - Radiation | 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. | Baseline, mid-treatment at 2 weeks, and post-treatment at 1 month |
| Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Total Liver Function: Cohort A - Radiation | 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. | Baseline, mid-treatment at 2 weeks, and post-treatment at 1 month |
| Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Spatial Heterogeneity: Cohort A - Radiation | 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. | Baseline, mid-treatment at 2 weeks, and post-treatment at 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Functional Liver Volume: Cohort B - 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Smith Apisarnthanarax | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States | ||
| ProCure Proton Therapy Center-Seattle |
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| ID | Title | Description |
|---|---|---|
| FG000 | SC SPECT/CT: Cohort A - Radiation | Cohort A includes all subjects receiving radiation therapy per standard of care. 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 radiation treatment (RT) or surgery. Two follow up scans are part of the protocol. The first follow up scan occurs at mid-RT, and the second one at 1-month post-RT. Computed Tomography: Undergo SC SPECT/CT Single Photon Emission Computed Tomography: Undergo SC SPECT/CT Technetium Tc-99m Sulfur Colloid: Given IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2023 |
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| Single Photon Emission Computed Tomography | Procedure | Undergo SC SPECT/CT |
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| Technetium Tc-99m Sulfur Colloid | Drug | Given IV |
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| Baseline, perioperative (2-3 days post surgery), and postoperative (1 month post surgery) |
| Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Liver-to-Spleen Mean: Cohort B - 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. | Baseline, perioperative (2-3 days post surgery), and postoperative (1 month post surgery) |
| Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Total Liver Function: Cohort B - 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. | Baseline, perioperative (2-3 days post surgery), and postoperative (1 month post surgery) |
| Seattle |
| Washington |
| 98133 |
| United States |
| FG001 | SC SPECT/CT: Cohort B - Surgery | Cohort B includes all subjects undergoing surgery per standard of care. 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. 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. Computed Tomography: Undergo SC SPECT/CT Single Photon Emission Computed Tomography: Undergo SC SPECT/CT Technetium Tc-99m Sulfur Colloid: Given IV |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SC SPECT/CT: Cohort A - Radiation | Cohort A includes all subjects receiving radiation therapy per standard of care. 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. The first follow up scan occurs at mid-RT, and the second one at 1-month post-RT. Computed Tomography: Undergo SC SPECT/CT Single Photon Emission Computed Tomography: Undergo SC SPECT/CT Technetium Tc-99m Sulfur Colloid: Given IV |
| BG001 | SC SPECT/CT: Cohort B - Surgery | Cohort B includes all subjects undergoing surgery per standard of care. 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. 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. Computed Tomography: Undergo SC SPECT/CT Single Photon Emission Computed Tomography: Undergo SC SPECT/CT Technetium Tc-99m Sulfur Colloid: Given IV |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Functional Liver Volume: Cohort A - Radiation | 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. | Only participants in Cohort A with evaluable treatment scans were assessed for this outcome. | Posted | Median | Full Range | ratio | Baseline, mid-treatment at 2 weeks, and post-treatment at 1 month |
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| Primary | Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Liver-to-Spleen Mean: Cohort A - Radiation | 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. | Only participants in Cohort A with evaluable treatment scans were assessed for this outcome. | Posted | Median | Full Range | ratio | Baseline, mid-treatment at 2 weeks, and post-treatment at 1 month |
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| Primary | Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Total Liver Function: Cohort A - Radiation | 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. | Only participants in Cohort A with evaluable treatment scans were assessed for this outcome. | Posted | Median | Full Range | ratio | Baseline, mid-treatment at 2 weeks, and post-treatment at 1 month |
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| Primary | Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Spatial Heterogeneity: Cohort A - Radiation | 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. | Only participants in Cohort A with evaluable treatment scans were assessed for this outcome. | Posted | Median | Full Range | ratio | Baseline, mid-treatment at 2 weeks, and post-treatment at 1 month |
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| Secondary | Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Functional Liver Volume: Cohort B - 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. | Cohort B - Only patients undergoing surgery | Posted | Median | Full Range | ratio | Baseline, perioperative (2-3 days post surgery), and postoperative (1 month post surgery) |
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| Secondary | Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Liver-to-Spleen Mean: Cohort B - 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. | Cohort B - Only patients undergoing surgery | Posted | Median | Full Range | ratio | Baseline, perioperative (2-3 days post surgery), and postoperative (1 month post surgery) |
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| Secondary | Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Total Liver Function: Cohort B - 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. | Cohort B - Only patients undergoing surgery | Posted | Median | Full Range | ratio | Baseline, perioperative (2-3 days post surgery), and postoperative (1 month post surgery) |
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Serious and Other AEs and All-Cause Mortality were assessed for up to 5 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SC SPECT/CT: Cohort A - Radiation | Cohort A includes all subjects receiving radiation therapy per standard of care. 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. The first follow up scan occurs at mid-RT, and the second one at 1-month post-RT. Computed Tomography: Undergo SC SPECT/CT Single Photon Emission Computed Tomography: Undergo SC SPECT/CT Technetium Tc-99m Sulfur Colloid: Given IV | 22 | 36 | 0 | 36 | 0 | 36 |
| EG001 | SC SPECT/CT: Cohort B - Surgery | Cohort B includes all subjects undergoing surgery per standard of care. 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. 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. Computed Tomography: Undergo SC SPECT/CT Single Photon Emission Computed Tomography: Undergo SC SPECT/CT Technetium Tc-99m Sulfur Colloid: Given IV | 1 | 3 | 0 | 3 | 0 | 3 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Smith Apisarnthanarax, Principal Investigator | University of Washington | +1 206 598-4100 | apisarn@uw.edu |
| Apr 3, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D018281 | Cholangiocarcinoma |
| D008113 | Liver Neoplasms |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014965 | X-Rays |
| D017785 | Photons |
| D013671 | Technetium Tc 99m Sulfur Colloid |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D004601 | Elementary Particles |
| D008027 | Light |
| D055620 | Optical Phenomena |
| D011840 | Radiation, Nonionizing |
| D013457 | Sulfur Compounds |
| D007287 | Inorganic Chemicals |
| D017556 | Technetium Compounds |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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