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Trial record 1 of 1 for:    NCT02881554
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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

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ClinicalTrials.gov Identifier: NCT02881554
Recruitment Status : Recruiting
First Posted : August 29, 2016
Last Update Posted : March 1, 2023
Sponsor:
Information provided by (Responsible Party):
University of Washington

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma Stage IV Liver Cancer Stage IVA Liver Cancer Stage IVB Liver Cancer Vascular Thrombosis Procedure: Computed Tomography Procedure: Single Photon Emission Computed Tomography Drug: Technetium Tc-99m Sulfur Colloid Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Functional Liver Imaging With Sulfur Colloid SPECT/CT in Primary and Metastatic Liver Cancer Patients Receiving Liver-Directed Treatment: A Pilot Study
Actual Study Start Date : December 21, 2016
Estimated Primary Completion Date : July 1, 2025
Estimated Study Completion Date : July 1, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Procedure: Computed Tomography
Undergo SC SPECT/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography

Procedure: Single Photon Emission Computed Tomography
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

Drug: Technetium Tc-99m Sulfur Colloid
Given IV
Other Names:
  • Tc 99m Sulfur Colloid
  • Tc-99m SC
  • Technetium Tc 99m Sulfur Colloid


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881554


Contacts
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Contact: Smith Apisarnthanarax 206-598-4100 apisarn@uw.edu

Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Smith Apisarnthanarax    206-598-4100    apisarn@uw.edu   
Principal Investigator: Smith Apisarnthanarax         
ProCure Proton Therapy Center-Seattle Recruiting
Seattle, Washington, United States, 98133
Contact: Smith Apisarnthanarax    206-598-4100    apisarn@uw.edu   
Principal Investigator: Smith Apisarnthanarax         
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Smith Apisarnthanarax Fred Hutch/University of Washington Cancer Consortium
More Information
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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT02881554    
Other Study ID Numbers: 9646
NCI-2016-01198 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9646 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
RG3116003 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: March 1, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Liver Neoplasms
Cholangiocarcinoma
Thrombosis
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
Technetium Tc 99m Sulfur Colloid
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action