Clinical trial NCT02881554: 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
Overall status: TERMINATED
Phase: NA
Conditions: Hepatocellular Carcinoma
Intrahepatic Cholangiocarcinoma
Stage IV Liver Cancer
Stage IVA Liver Cancer
Stage IVB Liver Cancer
Vascular Thrombosis
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2016-08-29
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Changes in sulfur colloid uptake in single photon emission computed tomography/computed tomography imaging
timeFrame: Baseline to last sulfur colloid single photon emission computed tomography/computed tomography, assessed up to 1 month
measure: Sulfur colloid (SC) uptake on single photon emission computed tomography/computed tomography (SPECT/CT) imaging
timeFrame: Up to 1 month
Secondary outcomes:
measure: Changes in sulfur colloid uptake in single photon emission computed tomography/computed tomography imaging
timeFrame: From the second sulfur colloid single photon emission computed tomography/computed tomography scan to the third scan, assessed up to 1 month
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
city: Seattle
country: United States
facility: ProCure Proton Therapy Center-Seattle
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Smith Apisarnthanarax
role: PRINCIPAL_INVESTIGATOR
References: