Evidence map›Paper›PMID 35858849›Full record

ArticleBMC cancer2022

ArTisaN trial protocol: a single Centre, open-label, phase II trial of the safety and efficacy of TheraSphere selective internal radiation therapy (SIRT) in the treatment of inoperable metastatic (liver) neuroendocrine neoplasia (NENs).

Rohini Sharma, Susanna Slater, Joanne Evans, Maria Martinez, Caroline Ward, Hooshang Izadi, Florian Wernig, Rob Thomas

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04362436 (A Phase II Assessment of the Safety and Efficacy of TheraSphere® Selective Internal Radiation Therapy), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 50% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04362436 phase2completednot on this map

A Phase II Assessment of the Safety and Efficacy of TheraSphere® Selective Internal Radiation Therapy (SIRT) in the Treatment of Metastatic (Liver) Neuroendocrine Tumours (NETs)

TypeinterventionalSponsorImperial College LondonRan2019 to 2023Enrolled24ConditionsNeuroendocrine Tumors, Liver MetastasesArmsTheraSpheres Selective Internal Radiation Therapy (SIRT)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Rohini SharmaDivision of Surgery and Cancer, Hammersmith Hospital, Imperial College London, Du Cane Road, London, W12 0NN, UK. r.sharma@imperial.ac.uk.ORCID http://orcid.org/0000-0003-2441-549X
Susanna SlaterDepartment of Oncology, Hammersmith Hospital, Imperial College NHS Healthcare Trust, Du Cane Road, London, W12 0HS, UK.
Joanne EvansDepartment of Oncology, Hammersmith Hospital, Imperial College NHS Healthcare Trust, Du Cane Road, London, W12 0HS, UK.
Maria MartinezDivision of Surgery and Cancer, Hammersmith Hospital, Imperial College London, Du Cane Road, London, W12 0NN, UK.
Caroline WardDivision of Surgery and Cancer, Hammersmith Hospital, Imperial College London, Du Cane Road, London, W12 0NN, UK.
Hooshang IzadiDepartment of Mechanical Engineering and Mathematical Sciences, Oxford Brookes University, Oxford, UK.
Florian WernigDepartment of Endocrinology, Hammersmith Hospital, Imperial College NHS Healthcare Trust, Du Cane Road, London, W12 0HS, UK.
Rob ThomasDepartment of Interventional Radiology, Hammersmith Hospital, Imperial College NHS Healthcare Trust, Du Cane Road, London, W12 0HS, UK.
Imperial College Healthcare NHS Trust · GBHammersmith Hospital · GBOxford Brookes University · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNeuroendocrine neoplasias (NENs) are a rare type of malignancy that arise from the cells of the neuroendocrine system. Most patients present with advanced, unresectable disease, typically with metastases to the liver. The presence of liver metastases dictates prognosis and there has been a number of studies investigating therapies that reduce the burden of liver disease. Selective Internal Radiation Therapy (SIRT) allows the delivery of targeted high dose radiation directly to tumours, with relative sparing of the surrounding liver tissue. Here, we describe the design and rationale of ArtTisaN, a phase II study to assess efficacy and tolerability of SIRT using TheraSpheres for the management of liver metastases secondary to NENs.

methodsTwenty-four eligible participants will be recruited to receive SIRT with TheraSpheres. The primary objective is to determine the objective response rate to treatment, defined as the rate of best overall response in the treated liver volume. In addition, total hepatic response and overall response will be assessed according to RECIST 1.1. The second co-primary objective is to determine the incidence of adverse and serious adverse device events. The secondary objectives are progression free survival, overall survival and quality of life. Additional exploratory objectives include investigation of circulating biomarkers of response and identification of a radiomic signature of response. DISCUSSION: This trial will provide prospective evidence on the efficacy of SIRT using TheraSpheres for the management of liver metastases.

trial registrationNCT04362436 .

Indexed as

Liver NeoplasmsNeuroendocrine TumorsBrachytherapyClinical Trials, Phase II as TopicHumansProspective StudiesQuality of LifeRadiopharmaceuticalsTreatment OutcomeRadiopharmaceuticalsNeuroendocrine neoplasiaQuality of lifeResponseSafetySelective internal radiotherapy

Identifiers

PMID35858849
PMCPMC9297626
OpenAlexW4285900252

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.