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Sulfur Colloid SPECT/CT for Liver Cancer

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 month

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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

~2720

Single Photon Emission Computed Tomography

2008

Completed Phase 4

~310

Technetium Tc-99m Sulfur Colloid

2016

Completed Phase 2

~160

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,741 Previous Clinical Trials

1,847,706 Total Patients Enrolled

Smith ApisarnthanaraxPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

Media Library

Single Photon Emission Computed Tomography Clinical Trial Eligibility Overview. Trial Name: NCT02881554 — N/A

Blood Clot Research Study Groups: Diagnostic (SC SPECT/CT)

Blood Clot Clinical Trial 2023: Single Photon Emission Computed Tomography Highlights & Side Effects. Trial Name: NCT02881554 — N/A

Single Photon Emission Computed Tomography 2023 Treatment Timeline for Medical Study. Trial Name: NCT02881554 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you elaborate on past research involving Single Photon Emission Computed Tomography?

"Currently, 4 investigations investigating Single Photon Emission Computed Tomography are in progress with 1 study being in its concluding Phase 3. Santa Monica is a hub for these experiments; however, there are 7 distinct centres currently running trials concerning this imaging technique."

Answered by AI

How many participants is the study looking to recruit?

"Correct. Records on clinicaltrials.gov demonstrate that this scientific investigation, which was originally posted in December 2016, is actively recruiting participants. In total, 60 individuals need to be registered from 2 different medical facilities."

Answered by AI

In what scenarios is Single Photon Emission Computed Tomography typically employed?

"Single Photon Emission Computed Tomography is a commonly prescribed intervention for hypovolaemia. It may also be used to assess drainage procedure, pulmonary aspiration of gastric contents, and functioning reticuloendothelial cells in the liver, spleen and bone marrow."

Answered by AI

Is this particular experiment a pathbreaking endeavor?

"Since 2008, Single Photon Emission Computed Tomography has been the object of rigorous clinical studies. The very first study was funded by NuRx Pharmaceuticals, Inc., and enrolled 65 participants. After receiving Phase 2 drug approval in 2008, it is now being tested across 5 cities located within one nation through 4 separate trials."

Answered by AI

Are recruitment efforts still underway for this clinical trial?

"Indeed, the details posted on clinicaltrials.gov demonstrate that this trial is now enlisting volunteers. The study was initially put up on December 21st 2016 and recently modified on August 16th 2022; they are seeking 60 participants from two different facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2016. "Sulfur Colloid SPECT/CT in Measuring Liver Function in Patients With Primary or Metastatic Liver Cancer Undergoing Radiation Therapy or Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02881554.

All > Intrahepatic Cholangiocarcinoma > Bile Duct Cancer