Contrast-Enhanced CT and MRI in Diagnosing and Staging Liver Cancer Using UNOS Policy (ACRIN 6690)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by American College of Radiology Imaging Network
Sponsor:
Collaborator:
Information provided by (Responsible Party):
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT01082224
First received: March 5, 2010
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Liver Cancer
Drug: iodinated contrast dye
Drug: motexafin gadolinium
Other: Eovist-enhanced MRI

Study Type: Interventional
Study Design: Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Prospective, Multicenter Comparison of Multiphase Contrast-Enhanced CT and Multiphase Contrast-Enhanced MRI for Diagnosis of Hepatocellular Carcinoma and Liver Transplant Allocation

Resource links provided by NLM:


Further study details as provided by American College of Radiology Imaging Network:

Primary Outcome Measures:
  • Sensitivity of contrast-enhanced CT scan vs contrast-enhanced MRI for diagnosing hepatocellular carcinoma (HCC) [ Time Frame: Within 90 Days Before Transplantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Positive predictive value (PPV) of CT scan vs MRI for diagnosing HCC [ Time Frame: Within 90 Days Before Transplantation ] [ Designated as safety issue: No ]
  • Lesion-level sensitivity and PPV of contrast CT scan vs contrast MRI [ Time Frame: Within 90 Days Before Transplantation ] [ Designated as safety issue: No ]
  • Sensitivity and specificity of multiphase contrast-enhanced CT scan vs MRI for diagnosing residual or recurrent HCC [ Time Frame: Within 90 Days Before Transplantation ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Within 90 Days Before Transplantation ] [ Designated as safety issue: No ]
  • Diagnostic value of sensitivity and PPV when patients are stratified by AFP level (elevated vs normal) [ Time Frame: Within 90 Days Before Transplantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 440
Study Start Date: December 2010
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Participants Waitlisted with HCC-Exception Points
Participants undergo CT and MRI every 90 days for the trial, during liver transplant wait listing. The primary objective is to assess the two modalities as radiologists apply the updated liver transplantation policy, which integrates the same imaging parameters as are being measured in ACRIN 6690. This trial will define how well the policy is functioning to improve stewardship in liver allocation.
Drug: iodinated contrast dye Drug: motexafin gadolinium Other: Eovist-enhanced MRI
A sub-study introduces the Eovist contrast agent for MRI scans at the same time points as the parent policy-assessment trial.

Detailed Description:

OBJECTIVES:

Primary

  • To compare the sensitivity of multiphase contrast-enhanced CT scan to that of multiphase contrast-enhanced MRI using non-specific contrast agents for diagnosing hepatocellular carcinoma (HCC) in patients with chronic liver disease.

Secondary

  • To compare the positive predictive value (PPV) of CT scan to that of MRI for diagnosing HCC.
  • To compare the lesion-level sensitivity and PPV of CT scan and MRI as interpreted by radiologists at the respective transplant centers.
  • To compare the sensitivity and specificity of multiphase contrast-enhanced CT scan vs MRI for diagnosing residual or recurrent HCC after local ablative therapy in patients listed for liver transplant.
  • To determine the accuracy of imaging-based diagnosis and staging of HCC in clinical practice using the new Organ Procurement and Transplantation Network (OPTN) liver-imaging criteria compared with the reference standard of pathologic diagnosis and staging at the time of explantation.
  • To explore whether the comparisons of sensitivity and PPV are affected by stratifying patients by AFP level (elevated vs normal). (Exploratory)

Tertiary

  • To assess the sensitivity and PPV of MRI and CT interpreted at the participating sites on the basis of all available information and sequences and compare the sensitivity and PPV of the two modalities interpreted using the main study criterion. (Exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to AFP level (elevated vs normal).

Patients undergo CT scan with iodinated contrast agent and MRI with extracellular gadolinium contrast agent (both standard-of-care and study-related) at baseline and at 90-day intervals while on the liver transplant wait list.

After transplantation, the explanted liver will be analyzed for biomarkers and other studies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082224

Locations
United States, Alabama
UAB Comprehensive Cancer Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Clinical Trials Office - UAB Comprehensive Cancer Center    205-934-0309      
United States, Arizona
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259-5499
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
United States, California
USC/Norris Comprehensive Cancer Center and Hospital Recruiting
Los Angeles, California, United States, 90089-9181
Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente    323-865-0451      
United States, Massachusetts
Lahey Clinic Medical Center - Burlington Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Clinical Trials Office - Lahey Clinic Medical Center - Burling    781-744-8027      
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109-0942
Contact: Clinical Trials Office - University of Michigan Comprehensive    800-865-1125      
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers    800-474-9892      
Sponsors and Collaborators
American College of Radiology Imaging Network
Investigators
Principal Investigator: Christoph Wald, MD, PhD Lahey Clinic Medical Center - Burlington
  More Information

Additional Information:
Publications:
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.

Responsible Party: American College of Radiology Imaging Network
ClinicalTrials.gov Identifier: NCT01082224     History of Changes
Other Study ID Numbers: CDR0000667125, ACRIN-6690, CA80098
Study First Received: March 5, 2010
Last Updated: August 19, 2013
Health Authority: United States: NCI

Keywords provided by American College of Radiology Imaging Network:
adult primary hepatocellular carcinoma
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Motexafin gadolinium
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Contrast Media
Diagnostic Uses of Chemicals
Photosensitizing Agents
Dermatologic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 01, 2014