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Sulfur Colloid SPECT/CT for Liver Cancer

N/A

Waitlist Available

Led By Smith Apisarnthanarax

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Patients unable to provide informed consent

Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 month

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well SPECT/CT with technetium Tc-99m sulfur colloid works in measuring liver function in patients with liver cancer.

Who is the study for?

This trial is for patients with liver cancer, including hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or metastatic liver cancer. They must be planning to receive radiation or surgery and have had a CT or MRI scan within the last 2 months. Participants need to understand and sign consent forms and agree to follow-up schedules. Pregnant women, those not using contraception when needed, and anyone unable to tolerate SPECT/CT scans are excluded.

What is being tested?

The trial tests how well a diagnostic procedure called sulfur colloid SPECT/CT with technetium Tc-99m can measure liver function in patients undergoing treatment for primary or metastatic liver cancer. It aims to help doctors plan more effective treatments by assessing normal liver tissue before, during, and after therapy.

What are the potential side effects?

While this study focuses on measuring liver function rather than treating the disease directly, potential side effects may include discomfort from the imaging process itself such as feeling claustrophobic inside the scanner or having an allergic reaction to contrast agents used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have liver cancer and am planned for high-dose radiation or surgery.

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I have liver cancer or a blood clot caused by cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand and give consent for my treatment.

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I am not using birth control and can become pregnant or cause pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sulfur colloid (SC) uptake on single photon emission computed tomography/computed tomography (SPECT/CT) imaging

Secondary study objectives

Changes in sulfur colloid uptake in single photon emission computed tomography/computed tomography imaging

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (SC SPECT/CT)Experimental Treatment3 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2740

Single Photon Emission Computed Tomography

2008

Completed Phase 4

~320