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).
Year: 2011
Type: conference-abstract
Abstract: TPS177 Background: New imaging criteria suggested by Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS) for computed tomography (CT) and magnetic resonance imaging (MRI) may accurately diagnose and stage HCC in patients with end-stage disease listed for LT. A large-scale clinical trial is needed to examine the utility of new liver imaging policy guidelines for deceased donor (DD) liver allocation. Data suggest current CT/MRI imaging criteria are inadequate, since 20% of LT recipients diagnosed with HCC by current criteria did not have HCC on explant (Freeman et al. Liver Transpl. 2006:1504-11). This trial compares the accuracy of radiologic staging of HCC by CT and MRI with the reference standard of explant pathology and compares the sensitivity and accuracy of CT and MRI to each other in diagnosing HCC in patients with cirrhosis. Optimally, the new policy will reduce false positive rate of imaging diagnosis of HCC and guide appropriate DD liver allocation. Methods: The trial cohort will comprise 440 participants from 30 ACRIN-qualified transplant centers in the 11 U.S. OPTN transplant regions. Eligible patients are diagnosed with HCC and initially listed for LT with priority HCC-exception MELD (Model for End-Stage Liver Disease) points within 30 days of trial enrollment. Participants will undergo CT and MRI every 90 days. The serial imaging series immediately prior to LT will be read using the new OPTN/UNOS policy and then compared with explant pathology. The primary aim will compare the sensitivity of CT to that of MRI for diagnosing HCC, at lesion and patient levels, in patients with cirrhosis awaiting LT. Additional aims will compare: positive predictive value of CT and MRI in diagnosing HCC, interpretations by radiologists at participating centers, and sensitivity and specificity of CT versus MRI for diagnosing residual or recurrent HCC after local ablative therapy. Exploratory analysis will examine the affects of AFP level on other trial analyses.
Source: Journal of Clinical Oncology
Authors: C. Wald, M. Nalesnik, E. A. Pomfret, M. Russo, M. A. Rosen, D. M. Hartfeil, P. Fox, M. L. Heckel, C. Gatsonis
Language: English
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W2563859128