Intra-arterial versus standard intravenous administration of lutetium-177-DOTA-octreotate in patients with NET liver metastases: study protocol for a multicenter, randomized controlled trial (LUTIA trial)

Trials

Adriaan Moelker¹  Marnix G. E. H. Lam¹  Arthur J. A. T. Braat¹  Sander C. Ebbers¹  Maarten W. Barentsz¹  Marcel P. M. Stokkel¹ 

[1] Department of Radiology and Nuclear Medicine, University Medical Center Utrecht;

关键词: Intra-arterial;    PRRT;    NET;    Neuroendocrine tumor;    Neuroendocrine neoplasm;    Lutetium-177-DOTATATE;   

DOI  :  10.1186/s13063-019-3888-0

来源: DOAJ

【 摘 要 】

Abstract Background Lutetium-177-DOTA-octreotate (177Lu-DOTATATE) significantly increases survival and response rates in patients with grade I and grade II neuroendocrine tumors (NETs). However, survival and response rates are significantly lower in patients with bulky liver metastases. Increasing the tumor-absorbed dose in liver metastases may improve response to 177Lu-DOTATATE. The LUTIA (Lutetium Intra-Arterial) study aims to increase the tumor-absorbed dose in liver metastases by intra-arterial (IA) administration of 177Lu-DOTATATE, compared to conventional intravenous (IV) administration. Methods A multicenter, within-patient randomized controlled trial (RCT) in 26 patients with progressive, liver-dominant, unresectable grade I or grade II NET will be conducted. Patients with bilobar bulky disease will be randomly allocated to receive IA treatment into either the left or the right hepatic artery. Using this approach, one liver lobe will be treated intra-arterially (first-pass effect), while the contralateral lobe will receive an intravenous treatment as a second-pass effect. The primary endpoint of this study is the difference in tumor-to-non-tumor ratio of 177Lu-DOTATATE uptake between the two liver lobes on post-treatment SPECT/CT (IA versus IV). Secondary endpoints include absorbed dose in both liver lobes, tumor response, dose-response relationship, toxicity, uptake in extrahepatic lesions, and renal uptake. Discussion This multicenter, within-patient RCT will investigate whether IA administration of 177Lu-DOTATATE results in a higher activity concentration in liver metastases compared to IV administration. Trial registration ClinicalTrials.gov, NCT03590119. Registered on 17 July 2018.

【 授权许可】

Unknown