Evidence map›Paper›PMID 38652200›Full record

Trial reportAnnals of surgical oncology2024

Radio-Guided Surgery with a New-Generation β-Probe for Radiolabeled Somatostatin Analog, in Patients with Small Intestinal Neuroendocrine Tumors.

Emilio Bertani, Francesco Mattana, Francesco Collamati, Mahila E Ferrari, Vincenzo Bagnardi, Samuele Frassoni, Eleonora Pisa, Riccardo Mirabelli, Silvio Morganti, Nicola Fazio and 2 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Annals of surgical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05448157 (68Ga-DOTATOC Radio-Guided Surgery With β-Probe in GEP-NET), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 10% 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.

NCT05448157 unknown statusnot on this map

68Ga-DOTATOC Radio-Guided Surgery With β-Probe in GEP-NET

TypeobservationalSponsorEuropean Institute of OncologyRan2022 to 2023Enrolled20ConditionsNeuroendocrine Tumor Carcinoid, Neuroendocrine Tumor of Pancreas, Gep Net
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. 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

12 authors at 5 institutions in 1 country.

Emilio BertaniNeuroendocrine Surgery Tumor Unit, IEO, European Institute of Oncology IRCCS, Milan, Italy. emilio.bertani@ieo.it.
Francesco MattanaDivision of Nuclear Medicine, IEO, European Institute of Oncology IRCCS, Milan, Italy.
Francesco CollamatiIstituto Nazionale di Fisica Nucleare INFN, Sezione di Roma, Rome, Italy.
Mahila E FerrariDivision of Medical Physics, IEO, European Institute of Oncology IRCCS, Milan, Italy.
Vincenzo BagnardiDepartment of Statistics and Quantitative Methods, University of Milan-Bicocca, Milan, Italy.
Samuele FrassoniDepartment of Statistics and Quantitative Methods, University of Milan-Bicocca, Milan, Italy.
Eleonora PisaDivision of Pathology, IEO, European Institute of Oncology IRCCS, Milan, Italy.
Riccardo MirabelliIstituto Nazionale di Fisica Nucleare INFN, Sezione di Roma, Rome, Italy.
Silvio MorgantiIstituto Nazionale di Fisica Nucleare INFN, Sezione di Roma, Rome, Italy.
Nicola FazioDivision of Gastrointestinal and Neuroendocrine Tumors Medical Treatment IEO, European Institute of Oncology IRCCS, Milan, Italy.
Uberto Fumagalli RomarioDivision of Digestive Surgery, IEO, European Institute of Oncology IRCCS, Milan, Italy.
Francesco CeciDivision of Nuclear Medicine, IEO, European Institute of Oncology IRCCS, Milan, Italy.
European Institute of Oncology · ITIstituto Nazionale di Fisica Nucleare · ITUniversity of Milano-Bicocca · ITSapienza University of Rome · ITUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRadio-guided surgery (RGS) holds promise for improving surgical outcomes in neuroendocrine tumors (NETs). Previous studies showed low specificity (SP) using γ-probes to detect radiation emitted by radio-labeled somatostatin analogs.

objectiveWe aimed to assess the sensitivity (SE) and SP of the intraoperative RGS approach using a β-probe with a per-lesion analysis, while assessing safety and feasibility as secondary objectives.

methodsThis prospective, single-arm, single-center, phase II trial (NCT05448157) enrolled 20 patients diagnosed with small intestine NETs (SI-NETs) with positive lesions detected at

resultsThe intraoperative RGS approach was feasible in all cases without adverse effects. Of 134 specimens, the AUC was 0.928, with a TBR cut-off of 1.35 yielding 89.3% SE and 86.4% SP. The median absorbed dose for the surgery staff was 30 µSv (range 12-41 µSv).

conclusionThis study reports optimal accuracy in detecting lesions of SI-NETs using the intraoperative RGS approach with a novel β-probe. The method was found to be safe, feasible, and easily reproducible in daily clinical practice, with minimal radiation exposure for the staff. RGS might potentially improve radical resection rates in SI-NETs. CLINICAL TRIALS REGISTRATION: CLINICALTRIALS: gov/ct2/show/NCT05448157 ].

Indexed as

Intestinal NeoplasmsIntestine, SmallNeuroendocrine TumorsOctreotidePositron Emission Tomography Computed TomographyRadiopharmaceuticalsSurgery, Computer-AssistedAdultAgedBeta ParticlesFeasibility StudiesFemaleFollow-Up StudiesHumansMaleMiddle AgedGa(III)-DOTATOCOctreotideOrganometallic CompoundsRadiopharmaceuticalsSomatostatin68Ga-DOTA-TOCLymph-node metastasesNeuroendocrine tumorsRadical surgeryRadio-guided surgeryβ-probe

Identifiers

PMID38652200
OpenAlexW4395036695

What OpenQuestion holds

Textmetadata
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.