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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-21

Study Completion Date

2025-02-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Correlation Between CT Perfusion and Post Y-90 TARE PET/CT Dosimetry

NCT02558205

Hepatocellular Carcinoma

WITHDRAWN

Radiation Therapy in Treating Patients With Hepatocellular Carcinoma, Cholangiocarcinoma, or Liver Metastasis Who Have Impaired Liver Function

NCT02626312

Cholangiocarcinoma Cirrhosis Hepatocellular Carcinoma +1 more

ACTIVE_NOT_RECRUITING PHASE1

Radiation Therapy With Sorafenib for TACE-Resistant Hepatocellular Carcinoma

NCT01618253

Hepatocellular Carcinoma Hepatocellular Cancer Hepatoma +1 more

WITHDRAWN PHASE1

Sorafenib Concurrent With Yttrium-90 Transarterial Radioembolization in Patients With Advanced Hepatocellular Cancer

NCT02288507

Hepatocellular Cancer

WITHDRAWN PHASE1

Contrast-Enhanced Ultrasound in Diagnosing Patients With Liver Cancer Undergoing Yttrium-90 Radioembolization

NCT03300401

Hepatocellular Carcinoma

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type PROCEDURE

Undergo SC SPECT/CT

Single Photon Emission Computed Tomography

Intervention Type PROCEDURE

Undergo SC SPECT/CT

Technetium Tc-99m Sulfur Colloid

Intervention Type DRUG

Given IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Computed Tomography

Undergo SC SPECT/CT

Intervention Type PROCEDURE

Single Photon Emission Computed Tomography

Undergo SC SPECT/CT

Intervention Type PROCEDURE

Technetium Tc-99m Sulfur Colloid

Given IV

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CAT CAT Scan Computerized Axial Tomography Computerized Tomography CT CT SCAN tomography 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 Tc 99m Sulfur Colloid Tc-99m SC Technetium Tc 99m Sulfur Colloid

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No