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

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American College of Radiology Imaging Network
• Collaborator: National Cancer Institute (NCI)
• Treatments: Liver Extracts; Motexafin gadolinium

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