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

February 22, 2024 updated by: University of Washington

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.

Study Overview

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: 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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Smith Apisarnthanarax
  • Phone Number: 206-598-4100
  • Email: apisarn@uw.edu

Study Locations

    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutch/University of Washington Cancer Consortium
        • Contact:
          • Smith Apisarnthanarax
          • Phone Number: 206-598-4100
          • Email: apisarn@uw.edu
        • Principal Investigator:
          • Smith Apisarnthanarax
      • Seattle, Washington, United States, 98133
        • Recruiting
        • ProCure Proton Therapy Center-Seattle
        • Contact:
          • Smith Apisarnthanarax
          • Phone Number: 206-598-4100
          • Email: apisarn@uw.edu
        • Principal Investigator:
          • Smith Apisarnthanarax

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (SC SPECT/CT)

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.
Undergo SC SPECT/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • tomography
  • CT SCAN
Undergo SC SPECT/CT
Other Names:
  • 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
Given IV
Other Names:
  • Tc 99m Sulfur Colloid
  • Tc-99m SC
  • Technetium Tc 99m Sulfur Colloid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in sulfur colloid uptake in single photon emission computed tomography/computed tomography imaging
Time Frame: Baseline to last sulfur colloid single photon emission computed tomography/computed tomography, assessed up to 1 month
Post-treatment changes in sulfur colloid uptake on single photon emission computed tomography/computed tomography imaging will be correlated with changes in clinical liver function. Relative changes in the parameters identified at baseline will be tested for correlation to changes in clinical liver function, including Child-Turcotte-Pugh score and albumin-bilirubin grade, as well as their individual constituents.
Baseline to last sulfur colloid single photon emission computed tomography/computed tomography, assessed up to 1 month
Sulfur colloid (SC) uptake on single photon emission computed tomography/computed tomography (SPECT/CT) imaging
Time Frame: Up to 1 month
To characterize whole-organ liver function, all pre-treatment SPECT/CT images will be analyzed for 1) ratios of maximum, mean, and total liver SC uptake relative to spleen SC uptake (L/S) and 2) volumetric SC parameters such as the functional liver volume formed by 58% maximum image intensity threshold segmentation. Optimal image thresholds for SC SPECT parameter association to Child-Turcotte-Pugh classification (A versus B/C class) will be interrogated by receiver-operator characteristic (ROC) analysis. Image thresholds that yield maximum area under the curve in quantitative parameters such a
Up to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in sulfur colloid uptake in single photon emission computed tomography/computed tomography imaging
Time Frame: From the second sulfur colloid single photon emission computed tomography/computed tomography scan to the third scan, assessed up to 1 month
The images will be processed similarly to the primary endpoints. Regional functional liver changes from scatter, collimator, and attenuation-corrected single photon emission computed tomography/computed tomography images will be modeled as a function of regional radiation dose. Three types of dose-response models will be defined to predict changes in liver function status.
From the second sulfur colloid single photon emission computed tomography/computed tomography scan to the third scan, assessed up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Smith Apisarnthanarax, Fred Hutch/University of Washington Cancer Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 23, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (Estimated)

August 29, 2016

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 9646 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
  • NCI-2016-01198 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • RG3116003 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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