NCT06168357

Brief Summary

Role of ADC value and DWI in abbreviated MRI compared to post-contrast CT in follow-up of HCC after TACE.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
17mo left

Started Jan 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Jan 2024Sep 2027

First Submitted

Initial submission to the registry

December 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Expected
Last Updated

December 13, 2023

Status Verified

November 1, 2023

Enrollment Period

1.7 years

First QC Date

December 5, 2023

Last Update Submit

December 5, 2023

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 31907050RESULT

  • European 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.

    PMID: 29628281RESULT

  • Sung 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.

    PMID: 33330098RESULT

  • Gluskin 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.

    PMID: 27471573RESULT

  • Wang 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.

    PMID: 28937853RESULT

  • Ludwig 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.

    PMID: 26854170RESULT

  • Surov 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.

    PMID: 33708636RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Nour Mokhles Farah, Resident doctor

CONTACT

01212872901Nmokhles492@gmail.com

Mostafa Ahmed Sayed, Lecturer

CONTACT

01092300511most.rad@aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

December 5, 2023

First Posted

December 13, 2023

Study Start

January 1, 2024

Primary Completion

September 30, 2025

Study Completion (Estimated)

September 30, 2027

Last Updated

December 13, 2023

Record last verified: 2023-11