Magnetic Resonance Elastography for Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TX
Carcinoma+8 More
Magnetic Resonance Elastography - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new imaging technique may help doctors determine if a treatment is working for patients with liver cancer.

See full description

Eligible Conditions

  • Carcinoma
  • Stage IVB Hepatocellular Carcinoma AJCC v8
  • Stage IIIA Hepatocellular Carcinoma AJCC v8
  • Stage IV Hepatocellular Carcinoma AJCC v8
  • Advanced Adult Hepatocellular Carcinoma
  • Stage III Hepatocellular Carcinoma AJCC v8
  • Stage IIIB Hepatocellular Carcinoma AJCC v8
  • Stage IVA Hepatocellular Carcinoma AJCC v8

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Magnetic Resonance Elastography will improve 2 primary outcomes and 3 secondary outcomes in patients with Carcinoma. Measurement will happen over the course of Baseline to 6 weeks.

18 months
Overall survival
Time to tumor progression
Baseline to 18 months
Change in tumor size and enhancement
Baseline to 6 weeks
Change in magnetic resonance elastography (MRE) liver tumor stiffness
Change in percent non-viable/necrotic tumor

Trial Safety

Trial Design

1 Treatment Group

Diagnostic (MRI/MRE)
1 of 1
Experimental Treatment

This trial requires 50 total participants across 1 different treatment group

This trial involves a single treatment. Magnetic Resonance Elastography 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 (MRI/MRE)Patients undergo standard of care MRI and MRE over 30-90 minutes within 5 days of liver biopsy before receiving any medical treatment for HCC, at 6 weeks after medical treatment for HCC, and then every 12 weeks for up to 24 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 2
~1120

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 18 months for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

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:
Liver cancer.
Available tumor and liver parenchyma tissue (biopsy-proven HCC).
No contraindications to MRI (such implanted ferromagnetic or pump devices, metallic fragments in eye), as indicated on our departmental MRI screening form.
Able to undergo informed consent.
Not pregnant.

Patient Q&A Section

What are the signs of carcinoma, hepatocellular?

"Among patients with cirrhosis, more than 40% have HCC. HCC in cirrhotics may appear clinically as abdominal pain, ascites, and/or hepatic masses. The most common type of HCC in cirrhotics is AFP-positive HCC. In cases with AFP-negative HCC, a large platelet count, a low serum albumin level, or poor liver function should be considered. In any case, however, the diagnosis of HCC in patients with cirrhosis requires a careful consideration of the clinical features, which may suggest the presence of a primary underlying hepatic neoplasm." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma, hepatocellular?

"In the United States, only an estimated 2% of patients with hepatocellular carcinoma have hepatitis B virus infection. The leading cause is hepatitis C virus, and only a third of individuals with chronic hepatitis C will develop liver cirrhosis." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma, hepatocellular?

"Patients with carcinoma, hepatocellular have an excellent prognosis if they are eligible for treatment with curative intent. Patients generally have to undergo chemotherapy, often combined with radiation, for local-regional control, while they are undergoing a systemic course of chemotherapy and hormonal therapy for metastatic disease. Although the extent of surgical resection may not be possible, some patients may be considered for locoregional therapy with the goal of achieving local control." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, hepatocellular?

"Carcinoma, hepatocellular is the most common type of [liver cancer](https://www.withpower.com/clinical-trials/liver-cancer) worldwide, and is the second-most common cause of liver cancer, following viral hepatitis. It is more common in men and is typically associated with a history of excessive alcohol consumption. The most common symptom of carcinoma, hepatocellular is a painful right upper quadrant abdominal mass. Patients with a history of chronic hepatitis B infection are particularly at risk of developing this type of cancer." - Anonymous Online Contributor

Unverified Answer

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

"There are approximately 21,540 cases of hepatocellular carcinoma diagnosed a year in the United States. Around 6,000 of these will be liver-related and 3,000 will metastasize." - Anonymous Online Contributor

Unverified Answer

Can carcinoma, hepatocellular be cured?

"The use of modern adjuvant therapy can yield 50% 5-year survival for patients with localized HCC. Patients with tumors up to 2.5 cm may show excellent local control, even with curative resection. The ability to cure patients is significantly linked to favorable tumor characteristics and early stage at time of surgery. Patients less than 40 years have an excellent overall survival after resection of HCC, especially in those without distant metastases." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of carcinoma, hepatocellular?

"There is growing evidence that obesity is associated with an increased risk of developing hepatocellular carcinoma. These observations may result from the fact that excess body fat is a risk factor for insulin resistance which in turn increases the risk of developing hepatocarcinogenesis. Therefore, any weight reduction may therefore contribute to a reduction in the risk of developing hepatocellular carcinoma." - Anonymous Online Contributor

Unverified Answer

Does carcinoma, hepatocellular run in families?

"No evidence was found for an aggregate increased risk of hepatocellular carcinoma (HCC) in the whole family of HBV-infected subjects but these findings may in part be explained by the clustering of HCC in familial cases. This familial clustering of HCC may in part be explained by a strong relationship between HCC and HBV infection, and family history of HCC may therefore only be helpful to identify HCC, but should not be used as a criterion to discontinue HBV vaccination." - Anonymous Online Contributor

Unverified Answer

How quickly does carcinoma, hepatocellular spread?

"Results from a recent clinical trial, patients with HCC developed HCC as a result of an acute form of carcinoma-related cirrhosis. HCC was usually associated with HCC-related cirrhosis 3 months, 1 year, or 2 years before clinical diagnosis of malignancy. After adjusting for tumor stage, age, and concurrent treatments, we found only a weak, nonsignificant relationship between HCC and initial diagnosis of cancer-related cirrhosis within 10 months. Results from a recent clinical trial indicate that a significant portion of those with HCC may not have HCC-related cirrhosis or would be diagnosed with HCC if their cirrhosis were not treated with antiviral and anti-fibrotic medications." - Anonymous Online Contributor

Unverified Answer

How does magnetic resonance elastography work?

"The application of MRE to the liver increases the visualization of lesions that can be detected using an ultrasound elastography at other sites. The use of MRE for the pretreatment evaluation of HCC patients is not a new treatment option, but the feasibility in other imaging modalities had limited evidence. Thus, our findings should be validated in a future study to examine the diagnostic role of MRE." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for carcinoma, hepatocellular?

"Survival time varies between different sites of origin of carcinoma, and among individual patients with specific risk factors. Although overall survival does not vary significantly by risk and site of origin, some subgroups have an improved survival rate compared to others. Those with extrahepatic spread, stage IV disease or more than two metastases are at a substantially increased hazard of death. Cancer 2015;121:1435-1444." - Anonymous Online Contributor

Unverified Answer

Is magnetic resonance elastography safe for people?

"The use of magnetic resonance elastography in people is well tolerable and may provide useful information on the stiffness of liver and spleen lesions. Magnetic resonance elastography is technically feasible and can be performed in selected patients with suspected liver cancer and, in part, with MRI safety and quality criteria." - Anonymous Online Contributor

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