Clinical trial NCT02057874: 3-Tesla MRI Response to TACE in HCC (Liver Cancer)
Official title: Multi-Parametric 3 Tesla Magnetic Resonance Imaging (MRI) of Response to Transarterial Chemoembolization (TACE) in Patients With Hepatocellular Carcinoma (HCC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Resectable Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Stage A Adult Primary Liver Cancer (BCLC)
Stage B Adult Primary Liver Cancer (BCLC)
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-02-07
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
measure: Correlation of Changes in Ktrans, ADC, MTR, and APTasym (Measured by DCE-, DW-, MT-, and CEST-MRI at 3 Tesla, Respectively) With Time-to-progression (TTP).
timeFrame: Baseline to up to 6 months post-TACE
measure: Correlation of Changes in Ktrans, ADC, MTR, and APTasym (Measured by DCE-, DW-, MT-, and CEST-MRI at 3 Tesla, Respectively) With Changes in the Ratio of Viable-to-necrotic Tumor Volume
timeFrame: Baseline to up to 12 weeks post-TACE
measure: Correlation of Ktrans, ADC, MTR, and APTasym (Measured by DCE-, DW-, MT-, and CEST-MRI at 3 Tesla, Respectively) With Pathological Response Within Explanted Tissue Following Orthotopic Liver Transplant (OLT)
timeFrame: Subset of patients undergoing OLT: within 12 hours following surgery
measure: Correlation of Changes in Ktrans, ADC, MTR, and APTasym (Measured by DCE-, DW-, MT-, and CEST-MRI at 3 Tesla, Respectively) With Overall Survival (OS)
timeFrame: Baseline to up to 6 months post-TACE
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: David L Gorden, MD
role: PRINCIPAL_INVESTIGATOR
References: