ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02881554
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02881554
Recruitment Status : Recruiting
First Posted : August 29, 2016
Last Update Posted : June 19, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

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:

PRIMARY OBJECTIVES:

I. Develop new quantitative metrics of baseline technetium Tc-99m sulfur colloid (SC) uptake on SPECT/CT imaging and correlate with clinical parameters of liver function and clinical outcomes in liver cancer patients receiving radiation therapy (RT) or surgery.

II. Correlate post-treatment changes in SC uptake on SPECT/CT imaging with changes in clinical liver function.

SECONDARY OBJECTIVES:

I. Estimate the dose response relationship on multiple spatial scales (global liver, regional liver, liver image voxel) between radiation dose and changes in SC uptake, both acutely (mid-RT) and subacutely (1 month post-RT), using SC SPECT/CT imaging.

II. Estimate the degree of radiation response in liver tissue with varying levels of function (i.e. compare radiation dose response of well compensated livers against less compensated livers).

III. Correlate SC uptake on SPECT/CT imaging in future liver remnant (FLR) with extent of liver hypertrophy after surgical resection.

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  (Clinical Trial)
Estimated Enrollment : 60 participants
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 : June 1, 2022


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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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


Locations
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
National Cancer Institute (NCI)
Investigators
Principal Investigator: Smith Apisarnthanarax Fred Hutch/University of Washington Cancer Consortium

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT02881554     History of Changes
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 )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Thrombosis
Liver Neoplasms
Cholangiocarcinoma
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