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

NCT02881554 | Terminated Results

• 3 other identifiers: 9646NCI-2016-01198RG3116003
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (1)

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.

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

Interventions

Computed Tomography PROCEDURE

Undergo SC SPECT/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography

Diagnostic (SC SPECT/CT)

Single Photon Emission Computed Tomography PROCEDURE

Undergo SC SPECT/CT

Also known as: Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon

Diagnostic (SC SPECT/CT)

Technetium Tc-99m Sulfur Colloid DRUG

Given IV

Also known as: Tc 99m Sulfur Colloid, Tc-99m SC, Technetium Tc 99m Sulfur Colloid

Diagnostic (SC SPECT/CT)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (2)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

ProCure Proton Therapy Center-Seattle

Seattle, Washington, 98133, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Cholangiocarcinoma; Liver Neoplasms; Thrombosis

Interventions

X-Rays; Photons; Technetium Tc 99m Sulfur Colloid

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Elementary Particles; Light; Optical Phenomena; Radiation, Nonionizing; Sulfur Compounds; Inorganic Chemicals; Technetium Compounds

Results Point of Contact

• Title: Dr. Smith Apisarnthanarax, Principal Investigator
• Organization: University of Washington

apisarn@uw.edu

+1 206 598-4100

Study Officials

• Smith Apisarnthanarax

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: August 29, 2016
• Study Start: December 21, 2016
• Primary Completion: July 31, 2024
• Study Completion: February 9, 2025
• Last Updated: October 29, 2025
• Results First Posted: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)