Hepatocellular CarcinomaNCT02881554
Sulfur Colloid SPECT/CT in Measuring Liver Function in Patients With Primary or Metastatic Liver Cancer Undergoing Radiation Therapy or Surgery
A study testing Computed Tomography, Single Photon Emission Computed Tomography and Technetium Tc-99m Sulfur Colloid in people with Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma, run by University of Washington at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, Stage IV Liver Cancer
- What is being tested?
- Computed Tomography, Single Photon Emission Computed Tomography and Technetium Tc-99m Sulfur Colloid
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Dec 2016to 9 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
ProCure Proton Therapy Center-Seattle
Seattle, Washington, 98133
About this study
Official title: Functional Liver Imaging With Sulfur Colloid SPECT/CT in Primary and Metastatic Liver Cancer Patients Receiving Liver-Directed Treatment: A Pilot Study
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, Stage IV Liver Cancer, Stage IVA Liver Cancer, Stage IVB Liver Cancer, Vascular Thrombosis
- Being tested
- Computed Tomography, Single Photon Emission Computed Tomography, Technetium Tc-99m Sulfur Colloid
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma, Liver Neoplasms, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography
Undergo SC SPECT/CT
Single Photon Emission Computed TomographyProcedure or surgery
Also called Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, single-photon emission computed tomography, SPECT
Undergo SC SPECT/CT
Technetium Tc-99m Sulfur ColloidDrug
Also called Tc 99m Sulfur Colloid, Tc-99m SC, Technetium Tc 99m Sulfur Colloid
Given IV
| Study group | Role | What they receive |
|---|---|---|
| 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.
* 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. Receives: Procedure: Computed Tomography; Procedure: Single Photon Emission Computed Tomography; Drug: Technetium Tc-99m Sulfur Colloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, mid-treatment at 2 weeks, and post-treatment at 1 month
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, perioperative (2-3 days post surgery), and postoperative (1 month post surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study start21 Dec 2016
- Primary completion31 Jul 2024
- Study completion9 Feb 2025
Why it stopped: Terminated due to low accrual in Cohort B. (Accrual goal for Cohort A was met.)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Smith Apisarnthanarax, University of Washington
- Investigators
- Smith Apisarnthanarax, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881554
- Sponsor's protocol ID
- 9646
- Other IDs
- NCI-2016-01198, 9646, RG3116003
- Status last verified
- Oct 2025
- First submitted
- 23 Aug 2016
- Last updated
- 29 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Liver Imaging With Sulfur Colloid SPECT/CT in Primary and Metastatic Liver Cancer Patients Receiving Liver-Directed Treatment: A Pilot Study
- ClinicalTrials.gov ID
- NCT02881554
- Acronym / sponsor ID
- 9646
- Conditions
- Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, Stage IV Liver Cancer, Stage IVA Liver Cancer, Stage IVB Liver Cancer, Vascular Thrombosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to low accrual in Cohort B. (Accrual goal for Cohort A was met.)
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 21 Dec 2016 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 9 Feb 2025 (actual)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Posted 29 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (SC SPECT/CT) | Experimental | Procedure: Computed Tomography, Procedure: Single Photon Emission Computed Tomography, Drug: Technetium Tc-99m Sulfur ColloidThere 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, Computerized TomographyUndergo SC SPECT/CT | Procedure or surgery | Diagnostic (SC SPECT/CT) |
| Single Photon Emission Computed TomographyAlso: Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, single-photon emission computed tomography, SPECTUndergo SC SPECT/CT | Procedure or surgery | Diagnostic (SC SPECT/CT) |
| Technetium Tc-99m Sulfur ColloidAlso: Tc 99m Sulfur Colloid, Tc-99m SC, Technetium Tc 99m Sulfur ColloidGiven IV | Drug | Diagnostic (SC SPECT/CT) |
Primary outcome
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Functional Liver Volume: Cohort A - Radiation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Functional Liver Volume: Cohort B - Surgery
Time frame: 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
Time frame: 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
Time frame: Baseline, perioperative (2-3 days post surgery), and postoperative (1 month post surgery)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Smith Apisarnthanarax principal investigator
Fred Hutch/University of Washington Cancer Consortium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed Tomography, Single Photon Emission Computed Tomography and Technetium Tc-99m Sulfur Colloid in people with Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal Changes in Liver Function as Measured by SC SPECT/CT Functional Liver Volume: Cohort A - Radiation (time frame: Baseline, mid-treatment at 2 weeks, and post-treatment at 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.