Contrast-Enhanced CT and MRI in Diagnosing and Staging Liver Cancer Using UNOS Policy (NCT01082224) | Clinical Trial Compass
UnknownNot Applicable
Contrast-Enhanced CT and MRI in Diagnosing and Staging Liver Cancer Using UNOS Policy
United States440 participantsStarted 2010-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 hepato…
What they're measuring
1
Sensitivity of contrast-enhanced CT scan vs contrast-enhanced MRI for diagnosing hepatocellular carcinoma (HCC)
Timeframe: Within 90 Days Before Transplantation
Trial details
NCT IDNCT01082224
SponsorAmerican College of Radiology Imaging Network