Trial Outcomes & Findings for Sulfur Colloid SPECT/CT in Measuring Liver Function in Patients With Primary or Metastatic Liver Cancer Undergoing Radiation Therapy or Surgery (NCT NCT02881554)
NCT ID: NCT02881554
Last Updated: 2025-10-29
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Baseline, mid-treatment at 2 weeks, and post-treatment at 1 month
Results posted on
2025-10-29
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
3
|
|
Overall Study
COMPLETED
|
36
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Sulfur Colloid SPECT/CT in Measuring Liver Function in Patients With Primary or Metastatic Liver Cancer Undergoing Radiation Therapy or Surgery
Baseline characteristics by cohort
| Measure |
SC SPECT/CT: Cohort A - Radiation
n=38 Participants
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
|
SC SPECT/CT: Cohort B - Surgery
n=3 Participants
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
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Continuous
|
71.87 years
n=5 Participants
|
74.67 years
n=7 Participants
|
72.07 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
3 participants
n=7 Participants
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, mid-treatment at 2 weeks, and post-treatment at 1 monthPopulation: Only participants in Cohort A with evaluable treatment scans were assessed for this outcome.
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.
Outcome measures
| Measure |
SC SPECT/CT: Cohort A - Radiation
n=36 Participants
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
|
Child-Pugh A Patients
Sub-population of patients with Child-Pugh A liver function who received 3 SPECT/CT imaging with 99mTc-SC: baseline, mid-treatment, and post-treatment.
|
Child-Pugh B/C Patients
Sub-population of patients with Child-Pugh B and C liver function who received 3 SPECT/CT imaging with 99mTc-SC: baseline, mid-treatment, and post-treatment.
|
|---|---|---|---|
|
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Functional Liver Volume: Cohort A - Radiation
Baseline FLV Ratio
|
0.36 ratio
Interval 0.01 to 0.63
|
—
|
—
|
|
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Functional Liver Volume: Cohort A - Radiation
Mid-Treatment FLV Ratio
|
0.34 ratio
Interval 0.0 to 0.67
|
—
|
—
|
|
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Functional Liver Volume: Cohort A - Radiation
Post-Treatment FLV Ratio
|
0.25 ratio
Interval 0.0 to 0.58
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, mid-treatment at 2 weeks, and post-treatment at 1 monthPopulation: Only participants in Cohort A with evaluable treatment scans were assessed for this outcome.
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.
Outcome measures
| Measure |
SC SPECT/CT: Cohort A - Radiation
n=36 Participants
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
|
Child-Pugh A Patients
Sub-population of patients with Child-Pugh A liver function who received 3 SPECT/CT imaging with 99mTc-SC: baseline, mid-treatment, and post-treatment.
|
Child-Pugh B/C Patients
Sub-population of patients with Child-Pugh B and C liver function who received 3 SPECT/CT imaging with 99mTc-SC: baseline, mid-treatment, and post-treatment.
|
|---|---|---|---|
|
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Liver-to-Spleen Mean: Cohort A - Radiation
Baseline L/S Ratio
|
1.11 ratio
Interval 0.37 to 2.83
|
—
|
—
|
|
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Liver-to-Spleen Mean: Cohort A - Radiation
Mid-Treatment L/S Ratio
|
0.96 ratio
Interval 0.38 to 2.83
|
—
|
—
|
|
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Liver-to-Spleen Mean: Cohort A - Radiation
Post-Treatment L/S Ratio
|
0.71 ratio
Interval 0.22 to 2.76
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, mid-treatment at 2 weeks, and post-treatment at 1 monthPopulation: Only participants in Cohort A with evaluable treatment scans were assessed for this outcome.
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.
Outcome measures
| Measure |
SC SPECT/CT: Cohort A - Radiation
n=36 Participants
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
|
Child-Pugh A Patients
n=22 Participants
Sub-population of patients with Child-Pugh A liver function who received 3 SPECT/CT imaging with 99mTc-SC: baseline, mid-treatment, and post-treatment.
|
Child-Pugh B/C Patients
n=11 Participants
Sub-population of patients with Child-Pugh B and C liver function who received 3 SPECT/CT imaging with 99mTc-SC: baseline, mid-treatment, and post-treatment.
|
|---|---|---|---|
|
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Total Liver Function: Cohort A - Radiation
Baseline TLF Ratio
|
0.41 ratio
Interval 0.0 to 1.78
|
0.44 ratio
Interval 0.05 to 1.78
|
0.18 ratio
Interval 0.0 to 0.55
|
|
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Total Liver Function: Cohort A - Radiation
Mid-Treatment TLF Ratio
|
0.29 ratio
Interval 0.0 to 1.29
|
0.39 ratio
Interval 0.11 to 1.29
|
0.15 ratio
Interval 0.0 to 0.72
|
|
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Total Liver Function: Cohort A - Radiation
Post-Treatment TLF Ratio
|
0.18 ratio
Interval 0.0 to 1.6
|
0.29 ratio
Interval 0.03 to 1.6
|
0.09 ratio
Interval 0.0 to 0.38
|
PRIMARY outcome
Timeframe: Baseline, mid-treatment at 2 weeks, and post-treatment at 1 monthPopulation: Only participants in Cohort A with evaluable treatment scans were assessed for this outcome.
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.
Outcome measures
| Measure |
SC SPECT/CT: Cohort A - Radiation
n=36 Participants
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
|
Child-Pugh A Patients
Sub-population of patients with Child-Pugh A liver function who received 3 SPECT/CT imaging with 99mTc-SC: baseline, mid-treatment, and post-treatment.
|
Child-Pugh B/C Patients
Sub-population of patients with Child-Pugh B and C liver function who received 3 SPECT/CT imaging with 99mTc-SC: baseline, mid-treatment, and post-treatment.
|
|---|---|---|---|
|
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Spatial Heterogeneity: Cohort A - Radiation
Baseline CV Ratio
|
0.38 ratio
Interval 0.28 to 0.69
|
—
|
—
|
|
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Spatial Heterogeneity: Cohort A - Radiation
Mid-Treatment CV Ratio
|
0.40 ratio
Interval 0.29 to 0.89
|
—
|
—
|
|
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Spatial Heterogeneity: Cohort A - Radiation
Post-Treatment CV Ratio
|
0.54 ratio
Interval 0.35 to 0.84
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, perioperative (2-3 days post surgery), and postoperative (1 month post surgery)Population: Cohort B - Only patients undergoing 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.
Outcome measures
| Measure |
SC SPECT/CT: Cohort A - Radiation
n=3 Participants
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
|
Child-Pugh A Patients
Sub-population of patients with Child-Pugh A liver function who received 3 SPECT/CT imaging with 99mTc-SC: baseline, mid-treatment, and post-treatment.
|
Child-Pugh B/C Patients
Sub-population of patients with Child-Pugh B and C liver function who received 3 SPECT/CT imaging with 99mTc-SC: baseline, mid-treatment, and post-treatment.
|
|---|---|---|---|
|
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Functional Liver Volume: Cohort B - Surgery
Preoperative FLV Ratio
|
0.52 ratio
Interval 0.39 to 0.58
|
—
|
—
|
|
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Functional Liver Volume: Cohort B - Surgery
Perioperative FLV Ratio
|
0.59 ratio
Interval 0.52 to 0.67
|
—
|
—
|
|
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Functional Liver Volume: Cohort B - Surgery
Postoperative FLV Ratio
|
0.54 ratio
Interval 0.53 to 0.64
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, perioperative (2-3 days post surgery), and postoperative (1 month post surgery)Population: Cohort B - Only patients undergoing 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.
Outcome measures
| Measure |
SC SPECT/CT: Cohort A - Radiation
n=3 Participants
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
|
Child-Pugh A Patients
Sub-population of patients with Child-Pugh A liver function who received 3 SPECT/CT imaging with 99mTc-SC: baseline, mid-treatment, and post-treatment.
|
Child-Pugh B/C Patients
Sub-population of patients with Child-Pugh B and C liver function who received 3 SPECT/CT imaging with 99mTc-SC: baseline, mid-treatment, and post-treatment.
|
|---|---|---|---|
|
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Liver-to-Spleen Mean: Cohort B - Surgery
Preoperative L/S Ratio
|
1.53 ratio
Interval 1.48 to 2.08
|
—
|
—
|
|
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Liver-to-Spleen Mean: Cohort B - Surgery
Perioperative L/S Ratio
|
1.23 ratio
Interval 1.1 to 2.78
|
—
|
—
|
|
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Liver-to-Spleen Mean: Cohort B - Surgery
Postoperative L/S Ratio
|
1.71 ratio
Interval 0.91 to 2.57
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, perioperative (2-3 days post surgery), and postoperative (1 month post surgery)Population: Cohort B - Only patients undergoing 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.
Outcome measures
| Measure |
SC SPECT/CT: Cohort A - Radiation
n=3 Participants
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
|
Child-Pugh A Patients
Sub-population of patients with Child-Pugh A liver function who received 3 SPECT/CT imaging with 99mTc-SC: baseline, mid-treatment, and post-treatment.
|
Child-Pugh B/C Patients
Sub-population of patients with Child-Pugh B and C liver function who received 3 SPECT/CT imaging with 99mTc-SC: baseline, mid-treatment, and post-treatment.
|
|---|---|---|---|
|
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Total Liver Function: Cohort B - Surgery
Perioperative TLF Ratio
|
0.73 ratio
Interval 0.64 to 1.63
|
—
|
—
|
|
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Total Liver Function: Cohort B - Surgery
Preoperative TLF Ratio
|
0.89 ratio
Interval 0.57 to 1.09
|
—
|
—
|
|
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Total Liver Function: Cohort B - Surgery
Postoperative TLF Ratio
|
1.1 ratio
Interval 0.49 to 1.37
|
—
|
—
|
Adverse Events
SC SPECT/CT: Cohort A - Radiation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 22 deaths
SC SPECT/CT: Cohort B - Surgery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Smith Apisarnthanarax, Principal Investigator
University of Washington
Phone: +1 206 598-4100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place