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)

Ebbers, Sander C.; Braat, Arthur J. A. T.; Moelker, Adriaan; Stokkel, Marcel P. M.; Lam, Marnix G. E. H.; Barentsz, Maarten W.

doi:10.1186/s13063-019-3888-0

Cited by 33 publications

(27 citation statements)

References 41 publications

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“…Unparalleled attempts to develop radiolabeled receptor-binding somatostatin analogues for the treatment of neuroendocrine tumors have occurred in recent decades, and these efforts have facilitated the evolution of PRRT and paved the way for the development of other receptor-targeting peptides. [96,[116][117][118]. The highest number of patients treated with locoregional administration of 213 Bi has been gathered with the treatment of grade II to IV glioma with radiolabeled DOTA-Substance P analog (substance-P binds to GPCR neurokinin type 1 receptor).…”

Section: Intracerebral Substance-p Prrtmentioning

confidence: 99%

Bismuth-213 for Targeted Radionuclide Therapy: From Atom to Bedside

Ahenkorah¹,

Cassells²,

Deroose³

et al. 2021

Preprint

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Besides external high-energy photon or proton beam therapy, targeted radionuclide therapy (TRNT) is an alternative approach to deliver radiation to cancer cells. TRNT is distributed within the body by the vascular system and allows targeted irradiation of a primary tumor and all its metastases, resulting in substantially less collateral damage to normal tissues as compared to ex-ternal beam radiotherapy (EBRT). It is a systemic cancer therapy, tackling systemic spread of the disease, which is the cause of death in most cancer patients. The α-emitting radionuclide bis-muth-213 (213Bi) has interesting properties and can be considered as a magic bullet for TRNT. The benefits and drawbacks of targeted alpha therapy with 213Bi are discussed in this review, covering the entire chain from radionuclide production to bedside. First, the radionuclide properties and production of 225Ac and its daughter 213Bi are discussed, followed by the fundamental chemical properties of bismuth. Next, an overview of available acyclic and macrocyclic bifunctional chelators for bismuth, and general considerations for designing a 213Bi-radiopharmaceutical are provided. Finally, we will provide an overview of preclinical and clinical studies involving 213Bi-radiopharmaceuticals, as well as the future perspectives of this promising cancer treatment option.

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Section: Intracerebral Substance-p Prrtmentioning

confidence: 99%

Bismuth-213 for Targeted Radionuclide Therapy: From Atom to Bedside

Ahenkorah¹,

Cassells²,

Deroose³

et al. 2021

Preprint

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“…In a non-randomized crossover-like diagnostic imaging study by Haberkorn et al, Ga-68 DOTATOC PET/CT was performed after both IV and IA administration; the standardized uptake values of DOTATOC in neuroendocrine tumors were approximately 3.75 times higher after IA administration [9]. An ongoing study in patients with neuroendocrine tumors, the LUTIA (Lutetium Intra-Arterial) study, aims to increase the tumor-absorbed dose in liver metastases IA vs IV administration of 177 Lu-Dotate [10]. This study will compare 177 Lu-Dotate activity in tumors in the IA-treated lobe with that in the IV-treated contralateral lobe, whereby the investigators will speci cally evaluate whether there is a difference in tumor-to-non-tumor activity concentration ratio on post-treatment SPECT/CT between IAand IV-treated liver lobes.…”

Section: Discussionmentioning

confidence: 99%

Selective Intra-Arterial 177Lu-PSMA Therapy for Castration Resistant Prostate Cancer: Preliminary Results of a Pilot Study

Sayman

Gülşen

Sağer

et al. 2021

Preprint

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Purpose177Lu-PSMA is a promising therapy for patients with metastatic castration resistant prostate cancer patients (mCRPC). To our knowledge, no study has compared the pharmacokinetic profiles of 177Lu-PSMA therapy delivered intra-arterially. We aimed to compare the feasibility and safety of selective intra-arterial (IA) administration vs conventional intravenous (IV) administration of 177Lu-PSMA in mCRPC. MethodsIn this within-patient pilot study, four patients (median age, 62.5; range, 53-72) with mCRPC who were referred to our clinic between January 2018 and September 2019 for treatment with 177Lu-PSMA. Patients were treated in two visits; in each visit receiving half of the total empiric therapeutic dose of 200 mCi, IV at the first visit and IA at the second visit. They were followed upto 8 weeks using routine parameters such as hematological status, renal function, and serum PSA levels. For each patient, organ biodistribution in lesions, kidneys, liver, bone marrow, prostate, and whole body was calculated for both administration routes according to the Medical Internal Radiation Dose (MIRD) schema. Mean absorbed doses (MAD) across all patients were compared between both administration routes. ResultsThe MAD of all metastatic lesions was significantly higher by IA vs IV administration (1.59 vs 1.20 MGy/MBq; p=0.024). The prostate gland had a lower MAD between IA and IV administrations, but the difference was not significant (0.27 vs 0.36 MGy/MBq; p=0.22). Patients tolerated IA administration very well without unexpected side effects. ConclusionThese preliminary results of an ongoing study showed that IA 177Lu-PSMA therapy is feasible and safe to treat metastatic lesions, potentially having a higher delivery efficacy compared to IV administration.This study is approved by Cerrahpasa Medical Faculty ethics committee on March 5, 2019 and retrospectively registered with file no: 83045809-604.01.02.

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“…Several non-controlled studies have evaluated the administration of different radiopharmaceuticals through the hepatic artery (e.g., 177Lu-DOTATATE, 90Y-DOTATOC, etc.) with promising results [148][149][150][151][152]. Currently, the randomized LUTIA study is comparing the tumor-absorbed dose in liver metastases after intra-arterial admin-istration of 177Lu-DOTATATE to that achieved after conventional intravenous administration [152].…”

Section: Somatostatin Receptors and Other Unique Targets In Nets 41 Rmentioning

confidence: 99%

“…with promising results [148][149][150][151][152]. Currently, the randomized LUTIA study is comparing the tumor-absorbed dose in liver metastases after intra-arterial admin-istration of 177Lu-DOTATATE to that achieved after conventional intravenous administration [152]. The results of this trial are awaited with great interest and may potentially lead to the development of a large phase 3 trial to investigate the long-term outcome of IA PRRT.…”

Section: Somatostatin Receptors and Other Unique Targets In Nets 41 Rmentioning

confidence: 99%

Targeted Cancer Therapy: What’s New in the Field of Neuroendocrine Neoplasms?

Salvia

Espinosa-Olarte

Riesco-Martinez

et al. 2021

Cancers

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Neuroendocrine tumors (NETs) are a heterogeneous family of neoplasms of increasing incidence and high prevalence due to their relatively indolent nature. Their wide anatomic distribution and their characteristic ability to secrete hormonally active substances pose unique challenges for clinical management. They are also characterized by the common expression of somatostatin receptors, a target that has been extremely useful for diagnosis and treatment (i.e., somatostatin analogues (SSAs) and peptide-receptor radionuclide therapy (PRRT)). Chemotherapy is of limited use for NETs of non-pancreatic origin, and the only approved targeted agents for advanced progressive NETs are sunitinib for those of pancreatic origin, and everolimus for lung, gastrointestinal and pancreatic primaries. Despite recent therapeutic achievements, thus, systemic treatment options remain limited. In this review we will discuss the state-of-the-art targeted therapies in the field of NETs, and also future perspectives of novel therapeutic drugs or strategies in clinical development, including recently presented results from randomized trials of yet unapproved antiangiogenic agents (i.e., pazopanib, surufatinib and axitinib), PRRT including both approved radiopharmaceuticals (177Lu-Oxodotreotide) and others in development (177Lu-Edotreotide, 177Lu-Satoreotide Tetraxetan), immunotherapy and other innovative targeted strategies (antibody-drug conjugates, bites,…) that shall soon improve the landscape of personalized treatment options in NET patients.

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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)

Cited by 33 publications

References 41 publications

Bismuth-213 for Targeted Radionuclide Therapy: From Atom to Bedside

Bismuth-213 for Targeted Radionuclide Therapy: From Atom to Bedside

Selective Intra-Arterial 177Lu-PSMA Therapy for Castration Resistant Prostate Cancer: Preliminary Results of a Pilot Study

Targeted Cancer Therapy: What’s New in the Field of Neuroendocrine Neoplasms?

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