Contrast-Enhanced CT and MRI in Diagnosing and Staging Liver Cancer Using UNOS Policy

NCT01082224 | Unknown DMC

• 4 other identifiers: CDR0000667125ACRIN-6690U01CA080098U01CA079778
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 9

Brief Summary

RATIONALE: Diagnostic procedures, such as contrast-enhanced CT scan and contrast-enhanced MRI, may help find liver cancer and find out how far the disease has spread. PURPOSE: This clinical trial is studying contrast-enhanced CT scan and contrast-enhanced MRI in diagnosing and staging liver cancer in patients with chronic liver disease.

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinoma; localized unresectable adult primary liver cancer; recurrent adult primary liver cancer

Outcome Measures

Primary Outcomes (1)

• Sensitivity of contrast-enhanced CT scan vs contrast-enhanced MRI for diagnosing hepatocellular carcinoma (HCC)

  Within 90 Days Before Transplantation

Secondary Outcomes (5)

• Positive predictive value (PPV) of CT scan vs MRI for diagnosing HCC

  Within 90 Days Before Transplantation

• Lesion-level sensitivity and PPV of contrast CT scan vs contrast MRI

  Within 90 Days Before Transplantation

• Sensitivity and specificity of multiphase contrast-enhanced CT scan vs MRI for diagnosing residual or recurrent HCC

  Within 90 Days Before Transplantation

• Accuracy of imaging-based diagnosis and staging of HCC in clinical practice using the new OPTN liver-imaging criteria compared with the reference standard of pathologic diagnosis and staging at the time of explantation

  Within 90 Days Before Transplantation

• Diagnostic value of sensitivity and PPV when patients are stratified by AFP level (elevated vs normal)

  Within 90 Days Before Transplantation

Study Arms (1)

Waitlisted with HCC-Exception Points

EXPERIMENTAL

Participants undergo CT and MRI every 90 days for the trial with iodinated contrast dye and motexafin gadolinium, during liver transplant wait listing. Possible Eovist-enhanced MRI substudy participation

Drug: iodinated contrast dye; Drug: motexafin gadolinium; Other: Eovist-enhanced MRI

Interventions

iodinated contrast dye DRUG

iodinated Radiocontrast dye for imaging enhancement

Also known as: iodinated radiographic dye

Waitlisted with HCC-Exception Points

motexafin gadolinium DRUG

motexafin gadolinium

Also known as: Xcytrin

Waitlisted with HCC-Exception Points

Eovist-enhanced MRI OTHER

A sub-study introduces the Eovist contrast agent for MRI scans at the same time points as the parent policy-assessment trial.

Waitlisted with HCC-Exception Points

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Presence of ≥ 1 focal liver lesion(s) compatible with imaging diagnosis of stage II hepatocellular carcinoma (HCC) (Organ Procurement and Transplantation Network \[OPTN\] Class 5B liver lesion) on contrast-enhanced CT scan and/or contrast-enhanced MRI OR 2 or 3 focal liver lesions, each between \> 1 and \< 3 cm diameter, if each is compatible with imaging diagnosis of HCC on contrast-enhanced CT imaging and/or contrast-enhanced MRI * Imaging findings must be within the Milan criteria * Listed on the regional OPTN/United Network for Organ Sharing (UNOS) liver transplant wait list with HCC-exception MELD points * Listed with the intent to undergo either deceased donor transplantation or live donor adult liver transplantation * No evidence of any of the following: * Extrahepatic tumor * Unifocal tumor mass \> 5 cm in diameter * Multifocal tumors ≥ 4 in number * Multiple (≤ 3) HCC with ≥ 1 tumor ≥ 3 cm in diameter PATIENT CHARACTERISTICS: * No renal failure, as determined by estimated GFR (eGFR) \< 30 mL/min * No renal insufficiency, as determined by eGFR 30-60 mL/min * Not pregnant * Negative pregnancy test * Able to comply with breathing and other imaging-related instructions resulting in ability to obtain diagnostic-quality CT scan or MRI studies (OPTN Class 0) * None of the following conditions that would make the patient unsuitable to undergo MRI with extracellular gadolinium-based contrast agent that does not have dominant hepatobiliary excretion: * Claustrophobia (unless alleviated with sedative treatment) * Presence of metallic objects or implanted medical devices in body per institutional safety standards * Sickle cell disease * Weight greater than that allowable by the MRI table * None of the following conditions that would make the patient unsuitable to undergo CT scan with an iodinated contrast agent: * Iodinated contrast allergy * Weight greater than that allowable by the CT table * No known allergy-like reaction to contrast media (iodinated or extracellular gadolinium that does not have dominant hepatobiliary excretion) or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology and unwilling to undergo pre-treatment PRIOR CONCURRENT THERAPY: * No local ablative therapy to the liver before study enrollment * No prior or concurrent sorafenib (or comparable antiangiogenic therapy) * Patients planning to undergo local ablative therapy after transplant listing and study enrollment are eligible provided they undergo CT scan and MRI within 28-60 days after completing the last ablative therapy session * Patients planning to receive transcatheter arterial chemoembolization (TACE) or combination therapy with TACE and thermal ablation are eligible provided they complete the entire treatment scheme per institutional standard of care before undergoing CT scan and MRI

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• American College of Radiology Imaging Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (9)

UAB Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Lahey Clinic Medical Center - Burlington

Burlington, Massachusetts, 01805, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Washington University, St. Louis

St Louis, Missouri, 63130, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

The Methodist Hospital for Liver Disease and Transplant

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Wald C, Nalesnik M, Pomfret EA, et al.: ACRIN 6690: can contemporary imaging reduce false-positive rate in liver transplant (LT) allocation? A multicenter comparison of CT and MRI for diagnosis of hepatocellular carcinoma (HCC). [Abstract] J Clin Oncol 29 (Suppl 15): A-TPS177, 2011.

  RESULT

• Mitchell DG, Bruix J, Sherman M, Sirlin CB. LI-RADS (Liver Imaging Reporting and Data System): summary, discussion, and consensus of the LI-RADS Management Working Group and future directions. Hepatology. 2015 Mar;61(3):1056-65. doi: 10.1002/hep.27304. Epub 2014 Dec 12.

  PMID: 25041904 DERIVED

Related Links

• ClinicalTrials.gov database

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

motexafin gadolinium

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Christoph Wald, MD, PhD

  Lahey Clinic Medical Center - Burlington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: March 8, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

US (9)