Sulfur Colloid SPECT/CT for Liver Cancer

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well a special imaging scan, called SPECT/CT, measures liver function in people with liver cancer undergoing radiation or surgery. The goal is to determine how these scans can help doctors plan better treatments by examining normal liver tissue before, during, and after treatment. The imaging uses Technetium Tc-99m Sulfur Colloid, a radiopharmaceutical. Suitable participants have liver cancer that may or may not have spread and are scheduled for either radiation therapy or surgery. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve future liver cancer treatments.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It allows for prior and concurrent treatments, so you may not need to stop them, but it's best to discuss this with the trial team.

What prior data suggests that this diagnostic procedure is safe for liver cancer patients?

Research has shown that Technetium Tc-99m sulfur colloid is usually well-tolerated for imaging, such as liver scans. This radioactive substance helps doctors assess the function of the liver and other organs. Most patients experience no serious side effects. However, rare cases of severe allergic reactions, including some fatal ones, have occurred. While these reactions are uncommon, awareness is crucial. Overall, its widespread use in diagnosing various conditions demonstrates the treatment's safety for medical imaging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Sulfur Colloid SPECT/CT for liver cancer because it offers a new way to visualize and monitor the disease. Unlike standard imaging methods, this technique uses Technetium Tc-99m Sulfur Colloid, which helps create detailed 3D images of liver tumors, potentially improving the precision of treatment planning. The ability to conduct multiple scans—before, during, and after treatment—means doctors can track how liver cancer responds in real-time, offering a more personalized approach to patient care. This innovative imaging could lead to better treatment outcomes by allowing adjustments to therapy based on how well the cancer is responding.

What evidence suggests that sulfur colloid SPECT/CT is effective for measuring liver function in liver cancer patients?

Research has shown that technetium Tc-99m sulfur colloid SPECT/CT is a promising method for assessing liver function in liver cancer patients. In this trial, participants will undergo SPECT/CT imaging to evaluate liver function after treatments such as radioembolization and surgery. This imaging technique allows doctors to see how different parts of the liver function, aiding in better treatment planning. By providing detailed images, it identifies healthy liver tissue and tracks changes over time, making it a valuable tool in managing liver cancer treatment. ^{1 3 6 7 8}

Who Is on the Research Team?

Smith Apisarnthanarax

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6726919/

Tc-99m sulfur colloid SPECT-CT and assessment of ... Tc-99 m SC SPECT-CT is a novel helper used to assess the differential liver function after Y90 radioembolization of HCC and before segmentectomy and lobectomy ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02881554

Study Details | NCT02881554 | Sulfur Colloid SPECT/CT in ... This pilot trial studies how well single photon emission computed tomography (SPECT)/computed tomography (CT) with technetium Tc-99m sulfur colloid works in ...

3. redjournal.org redjournal.org/article/S0360-3016(16)31338-4/fulltext

Outcomes of Patients With Hepatocellular Carcinoma and ... Hepatocellular carcinoma (HCC) remains a disease with poor overall survival. High dose radiation can provide a high local control rates and ...

4. jnm.snmjournals.org jnm.snmjournals.org/content/54/12/2055

99m Tc-Sulfur Colloid SPECT - Journal of Nuclear Medicine Conclusion: Dual-tracer 99mTc-MAA–99mTc-SC fusion SPECT offers a physiology-based imaging tool with significant prognostic power that may lead ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4731431/

Clinical impact of 99mTc-MAA SPECT/CT-based dosimetry in ... 99m Tc-MAA SPECT/CT-based dosimetry is of major interest in radioembolization conducted with radiolabeled microspheres.

6. go.drugbank.com go.drugbank.com/drugs/DB09397

Technetium Tc-99m sulfur colloid Anaphylactic reactions including rare fatalities have occurred following intravenously administered Technetium Tc 99m Sulfur Colloid. Radiation- ...

7. radiopaedia.org radiopaedia.org/articles/tc-99m-sulfur-colloid-4?lang=us

Tc-99m sulfur colloid | Radiology Reference Article Characteristics · photon energy: 140 keV · physical half-life: 6 hours · biological half-life: 2 to 3 minutes · normal distribution: liver: 85%.

8. mayoclinic.org mayoclinic.org/drugs-supplements/technetium-tc-99m-sulfurcolloid-injection-route-route-not-applicable/description/drg-20075776

Technetium tc 99m sulfurcolloid (injection route, route not ... Technetium Tc 99m sulfur colloid injection is used to find lymph node tumors in patients with breast cancer. It also helps your doctor see an image of your ...