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NCT02881554

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

Terminated NA Results posted Last updated 29 October 2025
What this trial tests

NA trial testing Computed Tomography in Hepatocellular Carcinoma in 41 participants. Terminated before completion.

Timeline
21 December 2016
Primary endpoint
31 July 2024
9 February 2025

Quick facts

Lead sponsorUniversity of Washington
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment41
Start date21 December 2016
Primary completion31 July 2024
Estimated completion9 February 2025
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Washington

Who can join

19 and older, any sex, with Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Functional Liver Volume: Cohort A - Radiation Primary · 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.

Baseline FLV Ratio
GroupValue95% CI
SC SPECT/CT: Cohort A - Radiation0.360.01 – 0.63
Mid-Treatment FLV Ratio
GroupValue95% CI
SC SPECT/CT: Cohort A - Radiation0.340.00 – 0.67
Post-Treatment FLV Ratio
GroupValue95% CI
SC SPECT/CT: Cohort A - Radiation0.250.00 – 0.58
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Liver-to-Spleen Mean: Cohort A - Radiation Primary · 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.

Baseline L/S Ratio
GroupValue95% CI
SC SPECT/CT: Cohort A - Radiation1.110.37 – 2.83
Mid-Treatment L/S Ratio
GroupValue95% CI
SC SPECT/CT: Cohort A - Radiation0.960.38 – 2.83
Post-Treatment L/S Ratio
GroupValue95% CI
SC SPECT/CT: Cohort A - Radiation0.710.22 – 2.76
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Total Liver Function: Cohort A - Radiation Primary · 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.

Baseline TLF Ratio
GroupValue95% CI
All Patients0.410.00 – 1.78
Child-Pugh A Patients0.440.05 – 1.78
Child-Pugh B/C Patients0.180.00 – 0.55
Mid-Treatment TLF Ratio
GroupValue95% CI
All Patients0.290.00 – 1.29
Child-Pugh A Patients0.390.11 – 1.29
Child-Pugh B/C Patients0.150.00 – 0.72
Post-Treatment TLF Ratio
GroupValue95% CI
All Patients0.180.00 – 1.60
Child-Pugh A Patients0.290.03 – 1.60
Child-Pugh B/C Patients0.090.00 – 0.38
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Spatial Heterogeneity: Cohort A - Radiation Primary · 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.

Baseline CV Ratio
GroupValue95% CI
SC SPECT/CT: Cohort A - Radiation0.380.28 – 0.69
Mid-Treatment CV Ratio
GroupValue95% CI
SC SPECT/CT: Cohort A - Radiation0.400.29 – 0.89
Post-Treatment CV Ratio
GroupValue95% CI
SC SPECT/CT: Cohort A - Radiation0.540.35 – 0.84
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Functional Liver Volume: Cohort B - Surgery Secondary · 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.

Preoperative FLV Ratio
GroupValue95% CI
SC SPECT/CT: Cohort B - Surgery0.520.39 – 0.58
Perioperative FLV Ratio
GroupValue95% CI
SC SPECT/CT: Cohort B - Surgery0.590.52 – 0.67
Postoperative FLV Ratio
GroupValue95% CI
SC SPECT/CT: Cohort B - Surgery0.540.53 – 0.64
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Liver-to-Spleen Mean: Cohort B - Surgery Secondary · 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.

Preoperative L/S Ratio
GroupValue95% CI
SC SPECT/CT: Cohort B - Surgery1.531.48 – 2.08
Perioperative L/S Ratio
GroupValue95% CI
SC SPECT/CT: Cohort B - Surgery1.231.10 – 2.78
Postoperative L/S Ratio
GroupValue95% CI
SC SPECT/CT: Cohort B - Surgery1.710.91 – 2.57
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Total Liver Function: Cohort B - Surgery Secondary · 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.

Preoperative TLF Ratio
GroupValue95% CI
SC SPECT/CT: Cohort B - Surgery0.890.57 – 1.09
Perioperative TLF Ratio
GroupValue95% CI
SC SPECT/CT: Cohort B - Surgery0.730.64 – 1.63
Postoperative TLF Ratio
GroupValue95% CI
SC SPECT/CT: Cohort B - Surgery1.10.49 – 1.37

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Radiation-Induced Liver Disease and Modern Radiotherapy.
    Koay EJ, Owen D, Das P. · · 2018 · cited 117× · PMID 30309642 · DOI 10.1016/j.semradonc.2018.06.007
  2. Nanoparticle-Based Activatable Probes for Bioimaging.
    Ma T, Xia T. · · 2021 · cited 6× · PMID 33724732 · DOI 10.1002/adbi.202000193

Verify or expand the search:

Other trials of Computed Tomography

Trials testing the same drug.

Other recruiting trials for Hepatocellular Carcinoma

Currently open trials in the same condition.

Other University of Washington trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02881554.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing