Sulfur Colloid SPECT/CT for Liver Cancer

Recruiting at 1 trial location

Overseen By Smith Apisarnthanarax

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Pregnancy, Inability to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Varies based on treatment type

48 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Smith Apisarnthanarax

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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.

Inclusion Criteria

You have had a CT or MRI scan within the past 2 months.

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

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

Exclusion Criteria

Patients who are not planning to adhere to the required follow up schedule as outlined in this protocol

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment Imaging

Initial SPECT/CT scan performed as routine medical care before initiation of radiation therapy or surgery

1 week

1 visit (in-person)

Treatment

Participants undergo radiation therapy or surgery as part of their standard cancer treatment

Varies based on treatment type

Follow-up Imaging

Two follow-up SPECT/CT scans to assess liver function changes, with additional IV contrast enhanced CT scan

1 month

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Technetium Tc-99m Sulfur Colloid

Trial Overview 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.

Participant Groups

Group I: Diagnostic (SC SPECT/CT) Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+