Clinical trial · Interventional
3-Tesla MRI Response to TACE in HCC (Liver Cancer)
Multi-Parametric 3 Tesla Magnetic Resonance Imaging (MRI) of Response to Transarterial Chemoembolization (TACE) in Patients With Hepatocellular Carcinoma (HCC)
NCT02057874CI-TRIAL-00033724terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding unavailable
Summary
Brief summary (as posted)
This pilot clinical trial examines how well different imaging biomarkers acquired using 3-Telsa magnetic resonance imaging (MRI) methods perform in determining treatment response to transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma. Compared to conventional imaging, multi-parametric 3-Tesla MRI offers the ability to quantitatively measure tissue structural, functional, cellular, and molecular properties, providing a more robust, clinically relevant method for assessing cancer response to therapy.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Primary Hepatocellular Carcinoma | Adult Hepatocellular Carcinoma | ALIAS | 0.90 |
| Advanced Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Localized Resectable Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Localized Unresectable Adult Primary Liver Cancer | — | UNRESOLVED | — |
| Stage A Adult Primary Liver Cancer (BCLC) | — | UNRESOLVED | — |
| Stage B Adult Primary Liver Cancer (BCLC) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3 Tesla Magnetic Resonance Imaging | Device | — | UNRESOLVED |
| Magnevist® (Intravenous (IV) administration of MRI contrast agent) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (3T MRI)
- description
- Patients undergo 3T MRI at baseline (=\< 2 weeks before TACE) and at 2-4 weeks, 4-8 weeks, and 12 weeks after TACE. Each 3T MRI session will utilize a sequence of the following modalities: CEST-MRI, MT-MRI, DW-MRI, and DCE-MRI.
- interventionNames
- Device: 3 Tesla Magnetic Resonance Imaging
- Drug: Magnevist® (Intravenous (IV) administration of MRI contrast agent)
Primary outcomes (1)
- measure
- Correlation of Changes in Imaging Biomarkers (Ktrans, ADC, MTR, and APTasym) as Measured by DCE-, DW-, MT-, and CEST-MRI at 3 Tesla, Respectively, With Changes in Tumor Volume (mRECIST).
- timeFrame
- Baseline to up to 12 weeks post-TACE
- description
- The following will be longitudinally measured using 3 Tesla (3T) magnetic resonance imaging (MRI) prior to transarterial chemoembolization (TACE) and 2-4, 4-8, and 12 weeks following TACE: 1) the volume transfer coefficient (Ktrans), measured by dynamic contrast-enhanced (DCE) MRI; 2) the apparent diffusion coefficient (ADC), measured by diffusion-weighted (DW) MRI; 3) the magnetization transfer ratio (MTR), measured by magnetization transfer (MT) MRI; and 4) the amide proton transfer asymmetry (APTasym), measured by chemical exchange saturation transfer (CEST) MRI. We will use a general linear model (GLM) approach to measure the association between changes in each of the above imaging metrics (relative to pretreatment baseline) and changes in tumor volume (according to standard-of-care modified RECIST) at 3 or 6 month follow-up, accounting for the effect of potential confounders, e.g., age and size of the tumor at baseline.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must have signed an institutional review board (IRB)-approved informed consent document * Subjects must have verified unresectable hepatocellular carcinoma (HCC), diagnosed on the basis of clinical and imaging criteria * Subjects must be classified as TNM stage I, II, or III; alternatively, subjects may be classified as Barcelona Clinic Liver Cancer (BCLC) stage A or B * Subjects must be scheduled to undergo transarterial chemoembolization (TACE) * Subjects must have at least 1 lesion being targeted by TACE that is \> 2 cm in the longest cross-sectional (axial plane) diameter * Subjects must satisfy one of the following conditions pertaining to their eligibility to undergo orthotopic liver transplantation (OLT): * HCC that is within Milan Criteria, i.e., TACE is indicated as a "bridge" to OLT (Group I); or * HCC that is outside Milan Criteria, i.e., TACE is indicated as a means of "down-staging" into transplant eligibility (Group II) Exclusion Criteria: * Subjects who have received prior treatment for HCC (prior surgical procedures not related to HCC are allowed) * Subjects who have undergone prior radioembolization * Subjects with a central venous line * Subjects who have any type of biomedical implant, device and/or ferromagnetic material that can be displaced, perturbed, or otherwise malfunction due to mechanical, electronic, or magnetic means; these items may include: * Metallic fragments or shrapnel (such as from war wounds) * Cerebral aneurysm clips, biopsy marker clips * Vascular access ports (as are used with intravenous chemotherapy) * Cochlear implants, pacemakers, neurostimulators, biostimulators, and electronic infusion pumps \*\*Implanted materials other than those verified as being rated "magnetic resonance \[MR\] Safe" or "MR Conditional 6" will not be allowed on study * Creatinine \>= 1.5 times upper limit of normal * Estimated glomerular filtration rate (eGFR) \< 30 mL/min * Subjects who are pregnant or nursing * Subjects who have had past allergic or other adverse reactions to intravenous injection of Magnevist® (gadopentetate dimeglumine) or other gadolinium-containing contrast agents * Subjects who exhibit noticeable anxiety, claustrophobia, or vertigo when moved into the scanner * Subjects incapable of giving informed written consent, for the following reasons: * Inability to adhere to the experimental protocols for any reason * Inability to communicate with the research team * Mental disability, altered mental status, confusion, or psychiatric disorders * Prisoners or others susceptible to coercion
References
Publications (0)
Data not yet available
No reference posted for this study.