Evidence map›Paper›PMID 37612610›Full record

ArticleBMC cancer2023

Study protocol for a multicenter randomised controlled trial on the (cost)effectiveness of biopsy combined with same-session MR-guided LITT versus biopsy alone in patients with primary irresectable glioblastoma (EMITT trial).

Céline L G Neutel, Ilaria Viozzi, Christiaan G Overduin, Anne Rijpma, Janneke P C Grutters, Gerjon Hannink, Pieter van Eijsden, Pierre A Robe, Maroeska M Rovers, Mark Ter Laan

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05318612 (), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.4field-weighted citation impact, top 17% 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.

NCT05318612 phase3active not recruitingnot on this map

(Cost)Effectiveness of MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma: a Prospective Multicenter Randomized Controlled Trial (EMITT)

TypeinterventionalSponsorRadboud University Medical CenterRan2022 to 2027Enrolled238ConditionsPrimary GlioblastomaArmsLaser Interstitial Thermal Therapy (LITT), Biopsy
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
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  5. Review
  6. Review
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

10 authors at 3 institutions in 1 country.

Céline L G Neutel *Department of Neurosurgery, Radboud University Medical Center, Nijmegen, The Netherlands.
Ilaria Viozzi *Department of Neurosurgery, Radboud University Medical Center, Nijmegen, The Netherlands.
Christiaan G OverduinDepartment of Medical Imaging, Radboud University Medical Center, Nijmegen, The Netherlands.
Anne RijpmaDepartment of Neurosurgery, Radboud University Medical Center, Nijmegen, The Netherlands.
Janneke P C GruttersDepartment for Health Evidence, Radboud University Medical Center, Nijmegen, The Netherlands.
Gerjon HanninkDepartment of Medical Imaging, Radboud University Medical Center, Nijmegen, The Netherlands.
Pieter van EijsdenDepartment of Neurosurgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Pierre A RobeDepartment of Neurosurgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Maroeska M RoversDepartment of Medical Imaging, Radboud University Medical Center, Nijmegen, The Netherlands.
Mark Ter LaanDepartment of Neurosurgery, Radboud University Medical Center, Nijmegen, The Netherlands. Mark.terLaan@radboudumc.nl.
Radboud University Nijmegen · NLRadboud University Medical Center · NLUniversity Medical Center Utrecht · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGlioblastoma (GBM) is the most common primary, malignant brain tumour with a 5-year survival of 5%. If possible, a glioblastoma is resected and further treated with chemoradiation therapy (CRT), but resection is not feasible in about 30% of cases. Current standard of care in these cases is a biopsy followed by CRT. Magnetic resonance (MR) imaging-guided laser interstitial thermal therapy (LITT) has been suggested as a minimally invasive alternative when surgery is not feasible. However, high-quality evidence directly comparing LITT with standard of care is lacking, precluding any conclusions on (cost-)effectiveness. We therefore propose a multicenter randomized controlled study to assess the (cost-)effectiveness of MR-guided LITT as compared to current standard of care (EMITT trial). METHODS AND ANALYSIS: The EMITT trial will be a multicenter pragmatic randomized controlled trial in the Netherlands. Seven Dutch hospitals will participate in this study. In total 238 patients will be randomized with 1:1 allocation to receive either biopsy combined with same-session MR-guided LITT therapy followed by CRT or the current standard of care being biopsy followed by CRT. The primary outcomes will be health-related quality of life (HR-QoL) (non-inferiority) using EORTC QLQ-C30 + BN20 scores at 5 months after randomization and overall survival (superiority). Secondary outcomes comprise cost-effectiveness (healthcare and societal perspective) and HR-QoL of life over an 18-month time horizon, progression free survival, tumour response, disease specific survival, longitudinal effects, effects on adjuvant treatment, ablation percentage and complication rates. DISCUSSION: The EMITT trial will be the first RCT on the effectiveness of LITT in patients with glioblastoma as compared with current standard of care. Together with the Dutch Brain Tumour Patient association, we hypothesize that LITT may improve overall survival without substantially affecting patients' quality of life.

trial registrationThis trial is registered at ClinicalTrials.gov (NCT05318612).

Indexed as

GlioblastomaHyperthermia, InducedAdjuvants, ImmunologicBiopsyEquivalence Trials as TopicHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicQuality of LifeRandomized Controlled Trials as TopicAdjuvants, ImmunologicAblationBrain neoplasmsGlioblastomaLaser ablationLaser therapyMagnetic resonance-guided laser-induced thermal therapy

Identifiers

PMID37612610
PMCPMC10463911
OpenAlexW4386092791

What OpenQuestion holds

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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.