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Hepatocellular CarcinomaNCT05716620

Utility of Abbreviated Magnetic Resonance Imaging as a Screening Tool for Hepatocellular Carcinoma in Cirrhotic Patients

An observational study of Hepatocellular Carcinoma, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this study is Utility of abbrevational magnetic resonance imaging as a screening tool for hepatocellular carcinoma in cirrhotic patients. The primary objective of the study is: HCC detection rate of US vs AMRI in cirrhotic patients The secondary objective of the study are: False referral rate of US vs… Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
MRI
How many people
380 participants
Where
1 siteIndia
Study dates
8 Feb 2022to 7 Feb 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients will be evaluated by two rounds of screening 6 months apart using paired US and non- enhanced AMRI. First round of screening will be performed within 6 months of a negative imaging prior to recruitment in patients who fulfill the inclusion and exclusion criteria discussed above. US and AMRI will be performed on the same day. US will be performed prior to MRI. US \& AMRI will be performed by the two radiologists independently. Fasting status will not be mandatory.Radiologists will be blinded to clinical details including the risk of HCC, tumor markers and to the results of other imaging tests.

Who may be able to join

  • Age>40 years
  • Presence of cirrhosis
  • Annual risk of HCC >5%
  • No HCC on pre-enrollment imaging not more than 6 months back.
  • Risk factors including diabetes mellitus, metabolic syndrome, family history of HCC.

Who cannot join

  • Child C status
  • Diagnosed or follow up case of HCC
  • Other malignancies
  • Pregnancy, lactation
  • Contraindications to MRI (pacemaker, cochlear implant, claustrophobia)
  • Chronic renal disease or contrast allergy precluding administration of intravenous MRI contrast agent (for reference standard)

Trial locations and contacts

1 site in 1 country.

PANKAJ GUPTA contact

8194896927 ext. 01722756508

pankajgupta959@gmail.com

India1 site, 1 recruiting

  • Post Graduate Institute of Medical Education and Research

    Chandigarh, Punjab, 160012

    Pankaj Gupta, 8194896927

    Recruiting

Other trials in India

About this study

The goal of this study is Utility of abbrevational magnetic resonance imaging as a screening tool for hepatocellular carcinoma in cirrhotic patients.

The primary objective of the study is:

  • HCC detection rate of US vs AMRI in cirrhotic patients

The secondary objective of the study are:

  • False referral rate of US vs AMRI: false referral will be defined as lack of HCC on complete MRI despite a positive US or AMRI.
  • Positive predictive value of US vs AMRI: The positive predictive value will be defined as the number of patients with true positive results in patients with positive US/AMRI.

Participants will be evaluated by two rounds of screening 6 months apart using paired US and non-enhanced AMRI.

Read the detailed description

Hepatocellular carcinoma (HCC) is the fifth most common cancer and is the second leading cause of cancer related death. The most important risk factor is cirrhosis of any etiology, particularly chronic hepatitis b and hepatitis c virus infection. Curative treatment (resection, transplant, or ablation) can be offered to patients diagnosed with early HCC. As the disease remains asymptomatic, most HCCs are diagnosed at an intermediate to terminal stage. Screening is an effective strategy to diagnose early HCC. The current guidelines recommend bi-annual screening with ultrasound (US) with or without alpha- fetoprotein (AFP). The overall sensitivity for detection of HCC using US screening is 60% while it is only 22% for detection of very early and early HCC. This results in many patients having progression of HCC despite being on screening program. Although computed tomography (CT) is widely available, the cumulative radiation dose from multiple screening CT scans makes CT screening unsuitable. Magnetic resonance imaging (MRI) has a high sensitivity and specificity for diagnosis of HCC owing to its high contrast resolution. A recent study showed significantly better sensitivity of HCC detection during screening using contrast enhanced MRI (CE-MRI) as compared with US. The use of CE-MRI entails high cost and risk of nephrogenic systemic fibrosis and is not well suited for screening from the health economics standpoint. Recently abbreviated MRI (AMRI) has been proposed as an acceptable alternative to US for HCC screening. AMRI involves acquisition of only a few MRI sequences rather than the complete MRI. This results in lesser table time and in turn reduced cost. However, most of the data is from retrospective studies. We propose a prospective study to evaluate the role of AMRI for HCC screening.

Being tested
MRI
Keywords
HCC, cirrhosis, chronic liver disease, hepatitis B & C
Medical subject headings
Carcinoma, Hepatocellular, Fibrosis, Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRIDiagnostic test

    Also called USG

    USG and MRI will be performed on the same day. US will be performed prior to MRI. There will be two rounds of screening 6 months apart using paired US and non-enhanced AMRI.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HCC detection rate of US vs AMRI in cirrhotic patients

    number of HCCs detected by US / AMRI divided by the actual number of HCCs based reference standard

    Measured: Day 7 from the time of enrolment till 12 month's scan

Secondary outcomes (5)

  1. False referral rate

    number of false positive results divided by the sum of true negative and false- positive results

    Measured: Day 7 from the time of enrolment till 12 month's scan

  2. Sensitivity, specificity of US vs AMRI

    Sensitivity, specificity of US vs AMRI

    Measured: Day 7 from the time of enrolment till 12 month's scan

  3. positive predictive value of US vs AMRI

    positive predictive value of US vs AMRI

    Measured: Day 7 from the time of enrolment till 12 month's scan

  4. negative predictive value of US vs AMRI

    negative predictive value of US vs AMRI

    Measured: Day 7 from the time of enrolment till 12 month's scan

  5. Survival of patients

    Patients who develop HCC during the 1-year follow up period using Kaplan Meier survival analysis.

    Measured: Day 7 from the time of enrolment till 12 month's scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2023
  2. Study start8 Feb 2022
  3. Primary completion7 Feb 2025 (estimated)
  4. Study completion7 Feb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
380 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05716620
Sponsor's protocol ID
10295
Status last verified
Jan 2023
First submitted
29 Jan 2023
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Center MM, Jemal A. International trends in liver cancer incidence rates. Cancer Epidemiol Biomarkers Prev. 2011 Nov;20(11):2362-8. doi: 10.1158/1055-9965.EPI-11-0643. Epub 2011 Sep 15.

    PubMed 21921256

  • Kalra N, Gupta P, Chawla Y, Khandelwal N. Locoregional treatment for hepatocellular carcinoma: The best is yet to come. World J Radiol. 2015 Oct 28;7(10):306-18. doi: 10.4329/wjr.v7.i10.306.

    PubMed 26516427

  • Roayaie S, Obeidat K, Sposito C, Mariani L, Bhoori S, Pellegrinelli A, Labow D, Llovet JM, Schwartz M, Mazzaferro V. Resection of hepatocellular cancer </=2 cm: results from two Western centers. Hepatology. 2013 Apr;57(4):1426-35. doi: 10.1002/hep.25832. Epub 2013 Jan 25.

    PubMed 22576353

  • Kanwal F, Singal AG. Surveillance for Hepatocellular Carcinoma: Current Best Practice and Future Direction. Gastroenterology. 2019 Jul;157(1):54-64. doi: 10.1053/j.gastro.2019.02.049. Epub 2019 Apr 12.

    PubMed 30986389

  • Singal A, Volk ML, Waljee A, Salgia R, Higgins P, Rogers MA, Marrero JA. Meta-analysis: surveillance with ultrasound for early-stage hepatocellular carcinoma in patients with cirrhosis. Aliment Pharmacol Ther. 2009 Jul;30(1):37-47. doi: 10.1111/j.1365-2036.2009.04014.x. Epub 2009 Apr 8.

    PubMed 19392863

  • Tzartzeva K, Obi J, Rich NE, Parikh ND, Marrero JA, Yopp A, Waljee AK, Singal AG. Surveillance Imaging and Alpha Fetoprotein for Early Detection of Hepatocellular Carcinoma in Patients With Cirrhosis: A Meta-analysis. Gastroenterology. 2018 May;154(6):1706-1718.e1. doi: 10.1053/j.gastro.2018.01.064. Epub 2018 Feb 6.

    PubMed 29425931

  • Kim YK, Kim YK, Park HJ, Park MJ, Lee WJ, Choi D. Noncontrast MRI with diffusion-weighted imaging as the sole imaging modality for detecting liver malignancy in patients with high risk for hepatocellular carcinoma. Magn Reson Imaging. 2014 Jul;32(6):610-8. doi: 10.1016/j.mri.2013.12.021. Epub 2014 Jan 13.

    PubMed 24702980

  • Nakamoto A, Yamamoto K, Sakane M, Nakai G, Higashiyama A, Juri H, Yoshikawa S, Narumi Y. Reduction of the radiation dose and the amount of contrast material in hepatic dynamic CT using low tube voltage and adaptive iterative dose reduction 3-dimensional. Medicine (Baltimore). 2018 Aug;97(34):e11857. doi: 10.1097/MD.0000000000011857.

    PubMed 30142778

  • Mazhar SM, Shiehmorteza M, Kohl CA, Middleton MS, Sirlin CB. Nephrogenic systemic fibrosis in liver disease: a systematic review. J Magn Reson Imaging. 2009 Dec;30(6):1313-22. doi: 10.1002/jmri.21983.

    PubMed 19937937

  • Gupta P, Singh S, Gulati A, Mudgil P, Kalra N, Dutta N, Aggarwal Y, Bhujade H, Chaluvashetty S, Premkumar M, Taneja S, Verma N, De A, Sharma V, Sandhu MS, Singh V, Duseja A. Noncontrast abbreviated MRI demonstrates superior diagnostic accuracy compared to ultrasound for hepatocellular carcinoma detection: Interim results from a prospective surveillance trial. Hepatology. 2026 May 11. doi: 10.1097/HEP.0000000000001788. Online ahead of print.

    PubMed 42113186

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact PANKAJ GUPTA (8194896927 ext. 01722756508, pankajgupta959@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HCC detection rate of US vs AMRI in cirrhotic patients (time frame: Day 7 from the time of enrolment till 12 month's scan). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05716620, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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Clinical Trial NCT05716620 | AzTrials