- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02881554
Sulfur Colloid SPECT/CT in Measuring Liver Function in Patients With Primary or Metastatic Liver Cancer Undergoing Radiation Therapy or Surgery
Functional Liver Imaging With Sulfur Colloid SPECT/CT in Primary and Metastatic Liver Cancer Patients Receiving Liver-Directed Treatment: A Pilot Study
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
|
Undergo SC SPECT/CT
Other Names:
Undergo SC SPECT/CT
Other Names:
Given IV
Other Names:
|
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
Sponsor
Investigators
- Principal Investigator: Smith Apisarnthanarax, Fred Hutch/University of Washington Cancer Consortium
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Embolism and Thrombosis
- Thrombosis
- Cholangiocarcinoma
- Liver Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Technetium Tc 99m Sulfur Colloid
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)?
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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