Technetium Tc-99m Sulfur Colloid for Carcinoma, Hepatocellular

Phase-Based Estimates
1
Effectiveness
1
Safety
ProCure Proton Therapy Center-Seattle, Seattle, WA
Carcinoma, Hepatocellular+9 More
Technetium Tc-99m Sulfur Colloid - Drug
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Hepatocellular

Study Summary

This study is evaluating whether a type of imaging test may help doctors plan better treatment for patients with liver cancer.

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Eligible Conditions

  • Carcinoma, Hepatocellular
  • Thrombus
  • Liver Neoplasms
  • Cholangiocarcinoma
  • Stage IVB Liver Cancer
  • Stage IV Liver Cancer
  • Stage IVA Liver Cancer
  • Vascular Thrombosis
  • Intrahepatic Cholangiocarcinoma
  • Thrombosis
  • Hepatocellular Carcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Technetium Tc-99m Sulfur Colloid will improve 1 primary outcome and 1 secondary outcome in patients with Carcinoma, Hepatocellular. Measurement will happen over the course of From the second sulfur colloid single photon emission computed tomography/computed tomography scan to the third scan, assessed up to 1 month.

Month 1
Changes in sulfur colloid uptake in single photon emission computed tomography/computed tomography imaging
Up to 1 month
Sulfur colloid (SC) uptake on single photon emission computed tomography/computed tomography (SPECT/CT) imaging

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Diagnostic (SC SPECT/CT)

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Technetium Tc-99m Sulfur Colloid is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

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.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~3460
Single Photon Emission Computed Tomography
2008
Completed Phase 4
~260
Gelatin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 month
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 1 month for reporting.

Closest Location

ProCure Proton Therapy Center-Seattle - Seattle, WA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Measurable hepatic disease and/or presence of vascular tumor thrombosis
for all patients A diagnostic CT scan or MRI will be performed on all patients within 2 months of study entry. show original
There are no limits on what therapies patients can receive prior to surgery show original
are both necessary for a person to be able to participate in a research study show original
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

Patient Q&A Section

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

Is technetium tc-99m sulfur colloid safe for people?

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Technetium tc-99m sulfur colloid, administered to patients for the detection of liver tumors and nodular liver disease, is as safe as conventional agents for liver surgery.

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What is carcinoma, hepatocellular?

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Carcinoma, hepatocellular is the most common type of malignancy of the liver diagnosed in the U.S.! There are many subtypes of hepatocellular carcinoma, each with characteristic imaging appearance and response to therapy.

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What are the signs of carcinoma, hepatocellular?

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The signs of HCC may not be pathognomatic in patients of the background of cirrhosis. In patients with hepatitis B virus the signs of HCC may consist of irregularly elevated serum AFP with rapid oncotic changes of the nodules, as well as with infiltration of the vessels with large tumor cells. HCC is a malignancy of hepatocytes. In patients with viral hepatitis without HCC in the background of cirrhosis the signs consist of rapid oncotic changes of liver nodules, as well as of diffuse hepatocyte necrosis with infiltration of intraparenchymal vessels with tumor cells and large vessel infiltration (with hepatocellular carcinoma).

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What are common treatments for carcinoma, hepatocellular?

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Many cases of HCV and HCV/HIV-associated cancers can be treated with antiviral drugs, including IFN alpha or its analog, or statins. Although statins have not been extensively used in HCV/HIV-associated cancers, their use should be recommended in light of recent studies showing its potential efficacy for anticancer effect.

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How many people get carcinoma, hepatocellular a year in the United States?

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We found 2.9 percent had carcinoma, hepatocellular in a year for males (2.7%) and 1.5 percent had carcinoma, hepatocellular in a year for females (0.9%). This rate should be compared to similar studies in developing countries. For other causes of cancers in the United States, rates were very different than those found for carcinoma, hepatocellular.

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Can carcinoma, hepatocellular be cured?

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Hepatomegaly is the leading cause of death due to liver carcinoma, and this may be reduced by chemotherapy or hepatic resection. It may be feasible for hepatic carcinoma to be cured.

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What causes carcinoma, hepatocellular?

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Hepatic carcinoma is a complex disease caused by a number of hereditary factors, environmental exposures and epigenetic changes to DNA. In rare cases it may be associated with chronic infection and inflammation. Carcinoma, hepatocytic is thought to be a multifactorial disease; its pathogenesis involves a complex and integrated interaction between chemical and genetic predisposition and environmental factors (see carcinogenesis).

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Is technetium tc-99m sulfur colloid typically used in combination with any other treatments?

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There is relatively little data related to the use of Tc-99m SL. However, Tc-99m SL frequently is used together with some type of other treatment. For instance, in one publication, SL scanning was used in combination with treatment procedures and clinical investigations. It is possible that the use of the Tc-99m SL is related to imaging or therapy and is not solely used to assess the patient. There seems to be much more overlap in the indications for and applications of Tc-99m SL scanning than has been reported and discussed in current literature. Despite the limitations of retrospective surveys, the results of this study are consistent with those from previous studies.

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What does technetium tc-99m sulfur colloid usually treat?

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Sulfur colloid rarely treats malignancies; the imaging pattern of this agent in patients with malignancies is characterized both by the imaging pattern of the malignancy itself and by the imaging pattern of the blood pool.

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How quickly does carcinoma, hepatocellular spread?

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Findings from a recent study demonstrates that carcinoma, hepatocellular spread occurs earlier in patients with cirrhosis who complain of abdominal or epigastric pain than that in patients without cirrhosis or ascites. No significant correlation was found in patients who complain of vomiting, anemia, jaundice or spleen enlargement.

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Have there been other clinical trials involving technetium tc-99m sulfur colloid?

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The most important conclusion of the present study is that sclerosing hepatic hemangiomas appear not to be an uncommon incidental finding on planar imaging and CT. Sclerosing hemangiomas occur in the central portion of the liver and should not be diagnosed as benign liver lesions or hepatocellular tumors while a Tc99mSO4 scan is being performed for other reasons.

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How does technetium tc-99m sulfur colloid work?

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The injected microbubbles are eliminated as fast as possible from the kidneys without detectable deposition. The high renal uptake and the lack of accumulation in the kidneys after 1 h show that the retention of Tc-99m in the tubules is short and depends on the particle size of the microbubbles. Nevertheless, a substantial kidney uptake of Tc-99m sulphur colloid can be observed up to 72 hours after injection. This finding is also observed in the liver, where the uptake of Tc-99m sulphur colloid by hepatic cells is higher than in the kidneys. This may explain why only minimal accumulation of the microbubbles in kidneys is detected after injection of small particles such as microbubbles.

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