Hepatocellular CarcinomaNCT06168357
Role of Abbreviated MRI in Follow-up of Hepatocellular Carcinoma .
An observational study of Hepatocellular Carcinoma, run by Assiut University.
Trial summary
Role of ADC value and DWI in abbreviated MRI compared to post-contrast CT in follow-up of HCC after TACE. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 85 years
- All sexes
- Adult, Older adult
Study population: Patients who underwent TACE for unresectable HCC with patent portal vein based on Doppler, no ascites, and satisfactory liver function. Age between 20-year old and 85-year old.
Who may be able to join
- Patients who underwent TACE for unresectable HCC with patent portal vein based on Doppler, no ascites, and satisfactory liver function.
- Age between 20-year old and 85-year old
Who cannot join
- Estimated GFR less than 60 Previous history of severe allergic reaction to the iodinated contrast agent Patients with claustrophobia who can't undergo MR examination. Patients having cochlear implants or cardiac pacemaker
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Role of Abbreviated MRI in Follow-up of Hepatocellular Carcinoma Following Locoregional Treatment.
Role of ADC value and DWI in abbreviated MRI compared to post-contrast CT in follow-up of HCC after TACE.
Read the detailed description
Hepatocellular carcinoma (HCC) is the 5th most common cancer in the world and the most common in Egypt .
Trans-arterial chemoembolization (TACE) is the treatment recommended for unresectable HCC according to Barcelona clinic liver cancer staging and is widely used .
HCC is nourished only by the hepatic artery, so TACE causes ischemia and coagulative necrosis. However; viable neoplastic tissue residual may be seen after TACE. Assessment of post-TACE tumor response is important in determining treatment success and in guiding future therapy .
Many studies have assessed the diagnostic performance of multiphasic contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI) in diagnosis of HCC with noted higher sensitivity of MRI compared to CT. CT or MRI are recommended for assessment of response after treatment as well .
Diffusion-weighted imaging (DWI) and apparent diffusion coefficient (ADC) are functional MRI techniques that detect signal changes in tissues due to water proton motion. The intact membranes of viable tumor cells restrict water diffusion, whereas necrotic tumor cells with disrupted cell membranes exhibit increased water diffusion and which differentiate the biological activity of HCC
- Conditions
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between tumor enhancement in arterial phase expressed as Hounsfield unit number and ADC value.
correlation between tumor enhancement in arterial phase expressed as Hounsfield unit number and ADC value.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study startJan 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nour Mokhles Farah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168357
- Sponsor's protocol ID
- Role of MRI in HCC
- Status last verified
- Nov 2023
- First submitted
- 5 Dec 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
Publications
Liu Z, Fan JM, He C, Li ZF, Xu YS, Li Z, Liu HF, Lei JQ. Utility of diffusion weighted imaging with the quantitative apparent diffusion coefficient in diagnosing residual or recurrent hepatocellular carcinoma after transarterial chemoembolization: a meta-analysis. Cancer Imaging. 2020 Jan 6;20(1):3. doi: 10.1186/s40644-019-0282-9.
PubMed 31907050European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):182-236. doi: 10.1016/j.jhep.2018.03.019. Epub 2018 Apr 5. No abstract available.
PubMed 29628281Sung PS, Choi MH, Yang H, Lee SK, Chun HJ, Jang JW, Choi JY, Yoon SK, Choi JI, Lee YJ, Bae SH. Diffusion-Weighted Magnetic Resonance Imaging in Hepatocellular Carcinoma as a Predictor of a Response to Cisplatin-Based Hepatic Arterial Infusion Chemotherapy. Front Oncol. 2020 Nov 19;10:600233. doi: 10.3389/fonc.2020.600233. eCollection 2020.
PubMed 33330098Gluskin JS, Chegai F, Monti S, Squillaci E, Mannelli L. Hepatocellular Carcinoma and Diffusion-Weighted MRI: Detection and Evaluation of Treatment Response. J Cancer. 2016 Jul 13;7(11):1565-70. doi: 10.7150/jca.14582. eCollection 2016.
PubMed 27471573Wang WT, Yang L, Yang ZX, Hu XX, Ding Y, Yan X, Fu CX, Grimm R, Zeng MS, Rao SX. Assessment of Microvascular Invasion of Hepatocellular Carcinoma with Diffusion Kurtosis Imaging. Radiology. 2018 Feb;286(2):571-580. doi: 10.1148/radiol.2017170515. Epub 2017 Sep 22.
PubMed 28937853Ludwig JM, Camacho JC, Kokabi N, Xing M, Kim HS. The Role of Diffusion-Weighted Imaging (DWI) in Locoregional Therapy Outcome Prediction and Response Assessment for Hepatocellular Carcinoma (HCC): The New Era of Functional Imaging Biomarkers. Diagnostics (Basel). 2015 Nov 30;5(4):546-63. doi: 10.3390/diagnostics5040546.
PubMed 26854170Surov A, Pech M, Omari J, Fischbach F, Damm R, Fischbach K, Powerski M, Relja B, Wienke A. Diffusion-Weighted Imaging Reflects Tumor Grading and Microvascular Invasion in Hepatocellular Carcinoma. Liver Cancer. 2021 Feb;10(1):10-24. doi: 10.1159/000511384. Epub 2021 Jan 27.
PubMed 33708636
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Abbreviated MRI in Follow-up of Hepatocellular Carcinoma Following Locoregional Treatment.
- ClinicalTrials.gov ID
- NCT06168357
- Acronym / sponsor ID
- Role of MRI in HCC
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Role of ADC value and DWI in abbreviated MRI compared to post-contrast CT in follow-up of HCC after TACE.
Detailed description
Hepatocellular carcinoma (HCC) is the 5th most common cancer in the world and the most common in Egypt .
Trans-arterial chemoembolization (TACE) is the treatment recommended for unresectable HCC according to Barcelona clinic liver cancer staging and is widely used .
HCC is nourished only by the hepatic artery, so TACE causes ischemia and coagulative necrosis. However; viable neoplastic tissue residual may be seen after TACE. Assessment of post-TACE tumor response is important in determining treatment success and in guiding future therapy .
Many studies have assessed the diagnostic performance of multiphasic contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI) in diagnosis of HCC with noted higher sensitivity of MRI compared to CT. CT or MRI are recommended for assessment of response after treatment as well .
Diffusion-weighted imaging (DWI) and apparent diffusion coefficient (ADC) are functional MRI techniques that detect signal changes in tissues due to water proton motion. The intact membranes of viable tumor cells restrict water diffusion, whereas necrotic tumor cells with disrupted cell membranes exhibit increased water diffusion and which differentiate the biological activity of HCC
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent TACE for unresectable HCC with patent portal vein based on Doppler, no ascites, and satisfactory liver function. Age between 20-year old and 85-year old.
Key inclusion criteria (2 listed)
- Patients who underwent TACE for unresectable HCC with patent portal vein based on Doppler, no ascites, and satisfactory liver function.
- Age between 20-year old and 85-year old
Key exclusion criteria (1 listed)
- Estimated GFR less than 60 Previous history of severe allergic reaction to the iodinated contrast agent Patients with claustrophobia who can't undergo MR examination. Patients having cochlear implants or cardiac pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between tumor enhancement in arterial phase expressed as Hounsfield unit number and ADC value.
Time frame: Baseline
correlation between tumor enhancement in arterial phase expressed as Hounsfield unit number and ADC value.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Results publication: PubMed 31907050Liu Z, Fan JM, He C, Li ZF, Xu YS, Li Z, Liu HF, Lei JQ. Utility of diffusion weighted imaging with the quantitative apparent diffusion coefficient in diagnosing residual or recurrent hepatocellular carcinoma after transarterial chemoembolization: a meta-analysis. Cancer Imaging. 2020 Jan 6;20(1):3. doi: 10.1186/s40644-019-0282-9.
- Results publication: PubMed 29628281European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):182-236. doi: 10.1016/j.jhep.2018.03.019. Epub 2018 Apr 5. No abstract available.
- Results publication: PubMed 33330098Sung PS, Choi MH, Yang H, Lee SK, Chun HJ, Jang JW, Choi JY, Yoon SK, Choi JI, Lee YJ, Bae SH. Diffusion-Weighted Magnetic Resonance Imaging in Hepatocellular Carcinoma as a Predictor of a Response to Cisplatin-Based Hepatic Arterial Infusion Chemotherapy. Front Oncol. 2020 Nov 19;10:600233. doi: 10.3389/fonc.2020.600233. eCollection 2020.
- Results publication: PubMed 27471573Gluskin JS, Chegai F, Monti S, Squillaci E, Mannelli L. Hepatocellular Carcinoma and Diffusion-Weighted MRI: Detection and Evaluation of Treatment Response. J Cancer. 2016 Jul 13;7(11):1565-70. doi: 10.7150/jca.14582. eCollection 2016.
- Results publication: PubMed 28937853Wang WT, Yang L, Yang ZX, Hu XX, Ding Y, Yan X, Fu CX, Grimm R, Zeng MS, Rao SX. Assessment of Microvascular Invasion of Hepatocellular Carcinoma with Diffusion Kurtosis Imaging. Radiology. 2018 Feb;286(2):571-580. doi: 10.1148/radiol.2017170515. Epub 2017 Sep 22.
- Results publication: PubMed 26854170Ludwig JM, Camacho JC, Kokabi N, Xing M, Kim HS. The Role of Diffusion-Weighted Imaging (DWI) in Locoregional Therapy Outcome Prediction and Response Assessment for Hepatocellular Carcinoma (HCC): The New Era of Functional Imaging Biomarkers. Diagnostics (Basel). 2015 Nov 30;5(4):546-63. doi: 10.3390/diagnostics5040546.
- Results publication: PubMed 33708636Surov A, Pech M, Omari J, Fischbach F, Damm R, Fischbach K, Powerski M, Relja B, Wienke A. Diffusion-Weighted Imaging Reflects Tumor Grading and Microvascular Invasion in Hepatocellular Carcinoma. Liver Cancer. 2021 Feb;10(1):10-24. doi: 10.1159/000511384. Epub 2021 Jan 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Assiut University.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nour Mokhles Farah, Resident doctor (01212872901, Nmokhles492@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between tumor enhancement in arterial phase expressed as Hounsfield unit number and ADC value. (time frame: Baseline). 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 NCT06168357, which also lists 7 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 13 Dec 2023.