Clinical trial · Observational
3T MRI to Predict TACE Response of HCC
Combination of Dynamic Contrast-enhanced and Diffusion-weighted Imaging and Magnetic Resonance Spectroscopy in 3T MRI to Early Predict Treatment Efficacy in Patients Receiving Transarterial Chemoembolization for Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a prospective clinical study using DCE-MRI, DWI and MRS in 3T scanner to evaluate tumors in patients with unresectable HCC after TACE. A total of 100 subjects will be recruited. MRI will be performed before TACE (day 0), day 14, and day 28 to assess the tumor responses. After day 28, all subjects will receive standard clinical care and be follow-up for 1 year. The imaging parameters will be compared among each MRI and correlate with patients' outcome. The investigators hypothesis that it might be helpful to combine DCE-MRI, DWI, and MRS for assessment of tumor response after TACE and predict patients' prognosis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- TACE patients, for HCC
- description
- unresectable HCC patients
Primary outcomes (1)
- measure
- tumor response
- timeFrame
- change of tumor size from baseline to at 6 months
- description
- change of tumor size from baseline to at 6 months
Secondary outcomes (1)
- measure
- change of baseline MRI parameters
- timeFrame
- change of MRI parameters from baseline to at 6 months
- description
- comparsion of MRI parameters from baseline to 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Prior Informed Consent Form 2. Patients who had undergone surgery for the treatment of HCC are allowed. 3. At least one measurable tumor, according to RECIST version 1.1. 4. Age more than 20 years. 5. ECOG performance status 0 or 1. 6. Life expectancy more than 3 months. 7. Child-Pugh class A. 8. Unresectable, multinodular tumors 9. Confirmed Diagnosis of HCC 10. At least one uni-dimensional lesion measurable according to the Modified RECIST criteria by MRI 11. Adequate bone marrow, liver and renal function Exclusion Criteria: 1. History of TACE 2. Diffuse infiltrative HCC or presence of main portal vein invasion or extrahepatic metastasis 3. Any contraindications for hepatic embolization procedures:, including hepatofugal blood flow, large intrahepatic or porto-systemic shunt, impaired clotting test, renal failure requiring hemo-or peritoneal dialysis 4. Any contraindication for MRI, including known contrast allergy, electronically operated implants or devices, and claustrophobia. 5. Other acute or chronic medical, psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and is inappropriate for this study by the judgment of the investigator 6. Known history of HIV infection 7. Concurrent primary extrahepatic cancer 8. Pregnant or breast-feeding subjects
References
Publications (0)
Data not yet available