CLINICAL TRIAL

Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid for Carcinoma, Hepatocellular

Recruiting · 18+ · All Sexes · La Jolla, CA

This study is evaluating whether a new type of MRI scan may be useful for detecting liver cancer.

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About the trial for Carcinoma, Hepatocellular

Eligible Conditions
Fibrosis · Liver Cirrhosis · Liver Cancer · Carcinoma, Hepatocellular · Hepatocellular Carcinoma · Cirrhosis of the Liver · Carcinoma

Treatment Groups

This trial involves 2 different treatments. Gadolinium Ethoxybenzyl Diethylenetriamine Pentaacetic Acid is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Subject has been fully informed and has personally signed and dated the written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) documents.
Adult subjects of any gender and any ethnic group with liver cirrhosis of any etiology
Subject is able and willing to complete required research procedures (screening/enrollment, clinical evaluation, safety procedures, lab collection if needed, research AMRI exam, research US exam) and the three optional surveys (if subject opts in for that) within specified time windows, and is willing to allow the study team to review clinical data including but not limited to other clinical radiology reports and images.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: up to one year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: up to one year.
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid will improve 2 primary outcomes in patients with Carcinoma, Hepatocellular. Measurement will happen over the course of up to 12 months from completion of imaging.

Reader reliability of screening modalities
UP TO 12 MONTHS FROM COMPLETION OF IMAGING
the inter- and intra-reader reliability of full AMRI vs. simulated unenhanced AMRI vs. US for HCC screening
Comparison of full AMRI, simulated unenhanced AMRI, and US for HCC detection
UP TO ONE YEAR
per-patient sensitivity, specificity, positive predictive (PPV), negative predictive value (NPV) and accuracy of full AMRI vs. simulated unenhanced AMRI vs. US for HCC screening

Who is running the study

Principal Investigator
C. S.
Prof. Claude Sirlin, Professor
University of California, San Diego

Patient Q & A Section

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

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

Hepatocellular carcinoma is the most common form of cancer in the United States. The incidence rate of HCC has increased steadily since 1960, and the number presenting with the disease is increasing.

Anonymous Patient Answer

Can carcinoma, hepatocellular be cured?

Although resection has a high curability rate (over seventy-five percent) for early stage patients who do not have cirrhosis, the local residual rate is much higher (over eighty percent), especially for those with cirrhosis.

Anonymous Patient Answer

What are the signs of carcinoma, hepatocellular?

Cirrhosis is a sign of cirrhosis and is usually a result of chronic alcoholism. Signs associated with liver cirrhosis include abdominal swelling, ascites, dark urine, hepatic encephalopathy, abdominal pain, or jaundice. Other nonspecific signs may include muscle tenderness, ascites, edema or swelling of the ankles due to pleural fluid, enlarged liver and enlarged spleen. Other nonspecific signs associated with liver cancer include itching, fever and weight loss.\n

Anonymous Patient Answer

What is carcinoma, hepatocellular?

There is a great deal of variability in clinical characteristics of this carcinoma; therefore, diagnostic accuracy is a significant issue. Although metastatic hepatocellular carcinoma has been previously considered a rare event, we have demonstrated a growing spectrum of disease presentation that has significant clinical management ramifications.

Anonymous Patient Answer

What causes carcinoma, hepatocellular?

In contrast to the current hypotheses, this study suggests that there is no association between liver cirrhosis and hepatocellular carcinoma, in the Taiwanese Taiwanese population.

Anonymous Patient Answer

What are common treatments for carcinoma, hepatocellular?

Common treatment for carcinoma, hepatocellular includes: surgery, radiotherapy, chemotherapy, embolization and biotherapy. There are no curative treatments for carcinoma, hepatocellular, so physicians seek to achieve long-term survival.

Anonymous Patient Answer

What is the primary cause of carcinoma, hepatocellular?

Based on this study, carcinoma, hepatocellular is primarily a disease of older persons, with an incidence of 7.5 per 100,000 person-years for females and 7.8 per 100,000 for males. On average, the likelihood of an occurrence for a given age group can be calculated as the log-normal distribution. The cumulative probability of carcinoma, hepatocellular occurring during the lifetime of a person whose age is 65 years is 0.719; this calculation implies that 0.719 X (0.716 - 0.719) = 73.78% chance of occurrence.

Anonymous Patient Answer

How serious can carcinoma, hepatocellular be?

A meta-regression analysis showed that liver cancer has 2-fold or higher risk of developing malignant neoplasm, and the proportion of advanced stage HCC is 20-30% higher in the metastasis group than the non-metastasis group.

Anonymous Patient Answer

What is the average age someone gets carcinoma, hepatocellular?

[Carcinoma, hepatocellular, at all ages is similar in incidence at (1.0-4.5 yr). A gradual and inverse association of this cancer with increasing age is observed in Caucasians, but in the Black population, the incidence of carcinoma, hepatocellular, increases. (Black: 1.1 yr vs. Black: 0.7 yr; p > 0.05; White: 1.9 yr vs. White: 0.7 yr; p > 0.

Anonymous Patient Answer

How quickly does carcinoma, hepatocellular spread?

The extent of tumour infiltration and metastasis to liver at the time of CCLM diagnosis are important prognostic factors that can be used to stratify prognostic risk groups in patients with hepatocellular carcinoma undergoing curative treatment.

Anonymous Patient Answer

What are the chances of developing carcinoma, hepatocellular?

It is important to recognize the signs and symptoms of liver disease that can help identify patients at an increased risk of developing malignant disease. In addition, clinicians should remember that even though the presence of atypical symptoms (i.e. fatigue, dizziness, jaundice) may hint towards a possible diagnosis, liver cancer can also present with these atypical symptoms.

Anonymous Patient Answer

What is the survival rate for carcinoma, hepatocellular?

In the present study, an overall 5-year survival rate for HCC was 46%. The prognosis (especially the prognosis of the curative hepatectomy) was slightly different between patient groups with and without cirrhosis. Thus, the resection of the liver may prevent cirrhosis progression to HCC.

Anonymous Patient Answer
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