Preoperative characterisation of clear-cell renal carcinoma using iodine-124-labelled antibody chimeric G250 ((124)I-cG250) and PET in patients with renal masses: a phase I trial Journal Article

  

Authors:	Divgi, C. R.; Pandit-Taskar, N.; Jungbluth, A. A.; Reuter, V. E.; Gonen, M.; Ruan, S.; Pierre, C.; Nagel, A.; Pryma, D. A.; Humm, J.; Larson, S. M.; Old, L. J.; Russo, P.
Article Title:	Preoperative characterisation of clear-cell renal carcinoma using iodine-124-labelled antibody chimeric G250 ((124)I-cG250) and PET in patients with renal masses: a phase I trial
Abstract:	Background: Preoperative identification of tumour type could have important implications for the choice of treatment for renal cancers. Antibody cG250 reacts against carbonic anhydrase-IX, which is over-expressed in clear-cell renal carcinomas. We aimed to assess whether iodine-124-labelled antibody chimeric G250 (124I-cG250) PET predicts clear-cell renal carcinoma, the most common and aggressive renal tumour. Methods: 26 patients with renal masses who were scheduled to undergo surgical resection by laparotomy received a single intravenous infusion of 185 MBq/10 mg of 124I-cG250 over 20 min in this open-label pilot study. Surgery was scheduled 1 week after 124I-cG250 infusion. PET and CT scanning of the abdomen, including the kidneys, within 3 h before surgery was planned for all patients. The obtained images were graded as positive (defined as a tumour-to-healthy-kidney ratio >3 to 1) or negative for antibody uptake, and the surgeon was informed of the scan results before surgery. After surgery, resected tumours were histopathologically classified as clear-cell renal carcinoma or otherwise. The trial is registered on the clinical trials site of the National Cancer Institute website http://clinicaltrials.gov/ct/show/NCT00199888. Findings: One patient received inactive antibody and was excluded from analysis. 15 of 16 clear-cell carcinomas were identified accurately by antibody PET, and all nine non-clear-cell renal masses were negative for the tracer. The sensitivity of 124I-cG250 PET for clear-cell kidney carcinoma in this trial was 94% (95% CI 70-100%); the negative predictive value was 90% (55-100%), and specificity and positive predictive accuracy were both 100% (66-100% and 78-100%, respectively). Interpretation: PET with 124I-cG250 can identify accurately clear-cell renal carcinoma; a negative scan is highly predictive of a less aggressive phenotype. Stratification of patients with renal masses by 124I-cG250 PET can identify aggressive tumours and help decide treatment. © 2007 Elsevier Ltd. All rights reserved.
Keywords:	adult; controlled study; human tissue; aged; middle aged; unclassified drug; clinical trial; disease course; drug tolerability; histopathology; postoperative period; preoperative care; positron emission tomography; diagnostic accuracy; laparotomy; preoperative evaluation; sensitivity and specificity; phenotype; computer assisted tomography; controlled clinical trial; diagnosis, differential; prediction; kidney carcinoma; kidney neoplasms; nephrectomy; drug hypersensitivity; confidence interval; antibodies, monoclonal; kidney; carcinoma, renal cell; iodine radioisotopes; diagnostic value; pilot study; pilot projects; positron-emission tomography; radiopharmaceutical agent; single drug dose; open study; phase 1 clinical trial; clear cell carcinoma; infusions, intravenous; monoclonal antibody g250 i 124
Journal Title:	Lancet Oncology
Volume:	8
Issue:	4
ISSN:	1470-2045
Publisher:	Elsevier Science, Inc.
Date Published:	2007-04-01
Start Page:	304
End Page:	310
Language:	English
DOI:	10.1016/s1470-2045(07)70044-x
PUBMED:	17395103
PROVIDER:	scopus
DOI/URL:	http://www.scopus.com/inward/record.url?eid=2-s2.0-33947504376&partnerID=40&md5=2f0af032f9ab699e2f0c09d347198f02
Notes:	--- - "Cited By (since 1996): 96" - "Export Date: 17 November 2011" - "CODEN: LOANB" - "Source: Scopus"

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