Clinical trial · Interventional
Contrast-Enhanced CT and MRI in Diagnosing and Staging Liver Cancer Using UNOS Policy
A Prospective, Multicenter Comparison of Multiphase Contrast-Enhanced CT and Multiphase Contrast-Enhanced MRI for Diagnosis of Hepatocellular Carcinoma and Liver Transplant Allocation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eovist-enhanced MRI | Other | — | UNRESOLVED |
| iodinated contrast dye | Drug | — | UNRESOLVED |
| motexafin gadolinium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Waitlisted with HCC-Exception Points
- description
- 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
- interventionNames
- Drug: iodinated contrast dye
- Drug: motexafin gadolinium
- Other: Eovist-enhanced MRI
Primary outcomes (1)
- measure
- Sensitivity of contrast-enhanced CT scan vs contrast-enhanced MRI for diagnosing hepatocellular carcinoma (HCC)
- timeFrame
- Within 90 Days Before Transplantation
Secondary outcomes (5)
- measure
- Positive predictive value (PPV) of CT scan vs MRI for diagnosing HCC
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTWald 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.
- DERIVEDMitchell 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