Evidence map›Paper›PMID 38772998›Full record

Observational studyEuropean journal of nuclear medicine and molecular imaging2024

Lutetium [

Secondo Lastoria, Marcello Rodari, Maddalena Sansovini, Sergio Baldari, Antonio D'Agostini, Anna Rita Cervino, Angelina Filice, Matteo Salgarello, Germano Perotti, Alberto Nieri and 11 more

Registry-linked trialAbstract readObservational StudyMulticenter Study
In one paragraph

Observational study in European journal of nuclear medicine and molecular imaging, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04727723 (Two Steps Italian Prospective obsErvationAL Study Assessing the Effectiveness and Outcomes Associated With LUtathera), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

NCT04727723 completednot on this map

Two Steps Italian Prospective obsErvationAL Study Assessing the Effectiveness and Outcomes Associated With LUtathera (177Lu) Oxodotreotide Treatment in Adult Subjects With Unresectable or Metastatic, Progressive, Well Differentiated (G1 and G2), Somatostatin Receptor Positive Gastroenteropancreatic-neuroendocrine Tumours (GEP-NETs) - REAL-LU

TypeobservationalSponsorNovartis PharmaceuticalsRan2021 to 2026Enrolled164ConditionsGastroenteropancreatic Neuroendocrine TumorArmsLutathera®
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. 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

21 authors.

Secondo LastoriaDivision of Nuclear Medicine, IRCCS Istituto Nazionale Tumori, "Fondazione Senatore Giovanni Pascale", Naples, Italy.ORCID 0000-0002-6649-9903
Marcello RodariNuclear Medicine Unit, IRCCS-Humanitas Clinical and Research Hospital, Rozzano, MI, Italy.ORCID 0000-0002-9419-8964
Maddalena SansoviniNuclear Medicine Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST), "Dino Amadori", Meldola, Italy.ORCID 0000-0002-7699-262X
Sergio BaldariDepartment of Biomedical and Dental Sciences and Morpho-Functional Imaging, University of Messina, Messina, Italy. sbaldari@unime.it.ORCID 0000-0002-4652-725X
Antonio D'AgostiniU.O.C. Medicina Nucleare-Ospedale "S.M. Goretti", Latina, Italy.
Anna Rita CervinoNuclear Medicine Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.ORCID 0000-0001-8201-1587
Angelina FiliceNuclear Medicine Unit, AUSL-IRCCS of Reggio Emilia, Reggio Emilia, Italy.ORCID 0000-0001-8483-1933
Matteo SalgarelloNuclear Medicine Department, Sacrocuore-Don Calabria Hospital, Negrar di Valpolicella, Italy.ORCID 0000-0001-8005-3986
Germano PerottiNuclear Medicine Unit, Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy.ORCID 0000-0002-2675-8384
Alberto NieriNuclear Medicine Unit, Onco-Hematological Department, University Hospital of Ferrara, Ferrara, Italy.ORCID 0000-0002-0952-1350
Davide CampanaOncology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.ORCID 0000-0002-4615-7340
Riccardo Emanuele PelleritoNuclear Medicine Unit, Ordine Mauriziano Hospital, Turin, Italy.
Elena PomposelliSC Medicina Nucleare, Azienda Ospedaliera-Universitaria SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.
Valeria GaudieriDepartment of Advanced Biomedical Sciences, University ''Federico II'' of Naples, Naples, Italy.ORCID 0000-0002-0560-2997
Giovanni StortoIRCCS CROB Referral Cancer Center of Basilicata, Rionero in Vulture (Pz), Italy.ORCID 0000-0002-6168-5598
Chiara Maria GranaRadiometabolic Therapy, Nuclear Medicine, IRCCS European Institute of Oncology, Milan, Italy.ORCID 0000-0002-3808-2174
Alberto SignoreNuclear Medicine Unit, Department of Medical-Surgical Sciences and Translational Medicine, University Hospital Sant'Andrea, "Sapienza" University of Rome, Rome, Italy.ORCID 0000-0001-8923-648X
Giuseppe BoniNuclear Medicine Therapy Unit, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.ORCID 0000-0001-6924-5450
Francesco DondiNuclear Medicine, ASST Spedali Civili di Brescia, Brescia, Italy.ORCID 0000-0003-4839-9033
Gabriele SimontacchiSODc Radiotherapy, Department of Oncology, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.ORCID 0000-0002-4005-6637
Ettore SeregniNuclear Medicine Unit, IRCCS-Fondazione Istituto Nazionale dei Tumori, Milan, Italy.ORCID 0000-0002-5097-049X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeGastroenteropancreatic -neuroendocrine tumours (GEP-NETs) are commonly treated with surgical resection or long-term therapies for tumour growth control. Lutetium [

methodsOverall duration of REAL-LU will be approximately 48 months, with 12- and 36-month recruitment and follow-up periods, respectively. The primary objective is to evaluate [

resultsAmong 161 evaluable patients, mean age was 64.7 ± 10.3 years at study entry, 83.8% presented with no clinical signs of disease at physical examination, and most had minor disease symptoms. All patients had metastatic disease, most commonly in the liver (83.9%) with a median of two metastatic sites. In 90.7% of patients, the disease was stage IV, and 68.3% had ≥ 1 target lesion. [

conclusionThe characteristics of patients who received [177Lu]Lu-DOTA-TATE in Italy are similar to those of the GEP-NET population of NETTER 1 with trial but with a higher proportion of patients with a grade 2 (71%). With regard to the tumor grade profile, our study cohort appears to be closer to that of NETTER-2 study population which included patients with G2 or G3 advanced GEP-NETs (i.e. Ki-67 ≥ 10% and ≤ 55%). Further analysis of effectiveness and safety can be anticipated as REAL-LU data mature. STUDY REGISTRATION: ClinicalTrials.gov, NCT04727723; Study Registration Date: 25 January, 2021; https://clinicaltrials.gov/study/NCT04727723?cond=NCT04727723&rank=1.

Indexed as

Intestinal NeoplasmsNeuroendocrine TumorsOctreotidePancreatic NeoplasmsStomach NeoplasmsAdultAgedFemaleHumansItalyLutetiumMaleMiddle AgedOrganometallic CompoundsProspective StudiesQuality of LifeLutetiumlutetium Lu 177 dotatateOctreotideOrganometallic CompoundsRadiopharmaceuticals[177Lu]Lu-DOTA-TATEGastroenteropancreatic-neuroendocrine tumoursItalyPeptide receptor radionuclide therapyREAL-LUReal-world

Identifiers

PMID38772998
PMCPMC11368969

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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.