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Liver CancerACRIN6690NCT01082224

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

A study testing iodinated contrast dye, motexafin gadolinium and Eovist-enhanced MRI in people with Liver Cancer, run by American College of Radiology Imaging Network at 9 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Cancer
What is being tested?
iodinated contrast dye, motexafin gadolinium and Eovist-enhanced MRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
9 sitesUnited States
Study dates
Dec 2010to Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • UAB Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Lahey Clinic Medical Center - Burlington

    Burlington, Massachusetts, 01805

  • The Methodist Hospital for Liver Disease and Transplant

    Houston, Texas, 77030

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • Washington University, St. Louis

    St Louis, Missouri, 63130

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Liver Cancer
Being tested
iodinated contrast dye, motexafin gadolinium, Eovist-enhanced MRI
Keywords
adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer
Medical subject headings
Liver Neoplasms, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iodinated contrast dyeDrug

    Also called iodinated radiographic dye

    iodinated Radiocontrast dye for imaging enhancement

  • motexafin gadoliniumDrug

    Also called Xcytrin

    motexafin gadolinium

  • Eovist-enhanced MRIOther

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

Study groups in NCT01082224
Study groupRoleWhat they receive
Waitlisted with HCC-Exception PointsExperimentalParticipants 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
Receives: Drug: iodinated contrast dye; Drug: motexafin gadolinium; Other: Eovist-enhanced MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Within 90 Days Before Transplantation

Secondary outcomes (5)

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

    Measured: Within 90 Days Before Transplantation

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

    Measured: Within 90 Days Before Transplantation

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

    Measured: Within 90 Days Before Transplantation

  4. 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

    Measured: Within 90 Days Before Transplantation

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

    Measured: Within 90 Days Before Transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
440 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01082224
Sponsor's protocol ID
CDR0000667125
Other IDs
ACRIN-6690, U01CA080098, U01CA079778
Acronym
ACRIN6690
Status last verified
Jul 2023
First submitted
5 Mar 2010
Last updated
7 Jul 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Data sharing plan is available on-line at https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx

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.

  • 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.

    PubMed 25041904

Questions about this trial

What is this clinical trial studying?

A study testing iodinated contrast dye, motexafin gadolinium and Eovist-enhanced MRI in people with Liver Cancer, run by American College of Radiology Imaging Network at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity of contrast-enhanced CT scan vs contrast-enhanced MRI for diagnosing hepatocellular carcinoma (HCC) (time frame: Within 90 Days Before Transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01082224, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.

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