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

Primary Purpose

Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, Stage IV Liver Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography
Single Photon Emission Computed Tomography
Technetium Tc-99m Sulfur Colloid
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fred Hutch/University of Washington Cancer ConsortiumRecruiting
  • ProCure Proton Therapy Center-SeattleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (SC SPECT/CT)

Arm Description

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.

Outcomes

Primary Outcome Measures

Changes in sulfur colloid uptake in single photon emission computed tomography/computed tomography imaging
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.
Sulfur colloid (SC) uptake on single photon emission computed tomography/computed tomography (SPECT/CT) imaging
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

Secondary Outcome Measures

Changes in sulfur colloid uptake in single photon emission computed tomography/computed tomography imaging
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.

Full Information

First Posted
August 23, 2016
Last Updated
September 6, 2023
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT02881554
Brief Title
Sulfur Colloid SPECT/CT in Measuring Liver Function in Patients With Primary or Metastatic Liver Cancer Undergoing Radiation Therapy or Surgery
Official Title
Functional Liver Imaging With Sulfur Colloid SPECT/CT in Primary and Metastatic Liver Cancer Patients Receiving Liver-Directed Treatment: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2016 (Actual)
Primary Completion Date
December 1, 2026 (Anticipated)
Study Completion Date
December 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Washington

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, Stage IV Liver Cancer, Stage IVA Liver Cancer, Stage IVB Liver Cancer, Vascular Thrombosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (SC SPECT/CT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography
Intervention Description
Undergo SC SPECT/CT
Intervention Type
Procedure
Intervention Name(s)
Single Photon Emission Computed Tomography
Other Intervention Name(s)
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
Intervention Description
Undergo SC SPECT/CT
Intervention Type
Drug
Intervention Name(s)
Technetium Tc-99m Sulfur Colloid
Other Intervention Name(s)
Tc 99m Sulfur Colloid, Tc-99m SC, Technetium Tc 99m Sulfur Colloid
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Changes in sulfur colloid uptake in single photon emission computed tomography/computed tomography imaging
Description
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.
Time Frame
Baseline to last sulfur colloid single photon emission computed tomography/computed tomography, assessed up to 1 month
Title
Sulfur colloid (SC) uptake on single photon emission computed tomography/computed tomography (SPECT/CT) imaging
Description
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
Time Frame
Up to 1 month
Secondary Outcome Measure Information:
Title
Changes in sulfur colloid uptake in single photon emission computed tomography/computed tomography imaging
Description
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.
Time Frame
From the second sulfur colloid single photon emission computed tomography/computed tomography scan to the third scan, assessed up to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Smith Apisarnthanarax
Phone
206-598-4100
Email
apisarn@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Smith Apisarnthanarax
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Smith Apisarnthanarax
Phone
206-598-4100
Email
apisarn@uw.edu
First Name & Middle Initial & Last Name & Degree
Smith Apisarnthanarax
Facility Name
ProCure Proton Therapy Center-Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Smith Apisarnthanarax
Phone
206-598-4100
Email
apisarn@uw.edu
First Name & Middle Initial & Last Name & Degree
Smith Apisarnthanarax

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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