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

University of Washington

Status: Terminated

Conditions: Vascular Thrombosis; Stage IVB Liver Cancer; Stage IV Liver Cancer; Intrahepatic Cholangiocarcinoma; Hepatocellular Carcinoma; Stage IVA Liver Cancer

Treatments: Procedure: Single Photon Emission Computed Tomography; Procedure: Computed Tomography; Drug: Technetium Tc-99m Sulfur Colloid

Study type: Interventional

Funder types: Other

Identifiers

NCT02881554

9646 (Other Identifier)

NCI-2016-01198 (Registry Identifier)

RG3116003 (Other Identifier)

Details and patient eligibility

About

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.

Full 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: radiation 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.

Enrollment: 41 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Diagnostic (SC SPECT/CT)

Experimental group

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.

Treatment:

Drug: Technetium Tc-99m Sulfur Colloid

Procedure: Computed Tomography

Procedure: Single Photon Emission Computed Tomography