Evidence map›Paper›PMID 39641193›Full record

Trial reportNuclear medicine communications2025

Safety observations in neuroblastoma patients undergoing 18 F- m FBG PET.

Neeta Pandit-Taskar, Ellen Basu, Eloisa Balquin, P David Mozley, Arnold F Jacobson, Shakeel Modak

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

Trial report in Nuclear medicine communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02348749 (A Phase I/IIA Study of 18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT02348749 phase1 / phase2completednot on this map

A Phase I/IIA Study of 18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan2015 to 2025Enrolled48ConditionsNeuroendocrine TumorsArms18F-MFBG (meta-fluoro benzylguanidine), Positron emission tomography (PET) imaging, Blood draws
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Lesion Analysis ofJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2025
    Article
  2. 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

6 authors.

Neeta Pandit-TaskarDepartments of Radiology.
Ellen BasuPediatrics, Memorial Sloan Kettering Cancer Center, New York City, New York.
Eloisa BalquinDepartments of Radiology.
P David MozleyInnervate Radiopharmaceuticals LLC, Englewood, New Jersey, USA.
Arnold F JacobsonInnervate Radiopharmaceuticals LLC, Englewood, New Jersey, USA.
Shakeel ModakPediatrics, Memorial Sloan Kettering Cancer Center, New York City, New York.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
A First-in-Human Pilot Study of 18F-MFBG Imaging for Evaluation of NeuroblastomaR01CA204093 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI PANDIT TASKAR, NEETA · 2017 to 2018
$784k
NCI NIH HHS P30 CA008748NCI NIH HHS R01 CA204093
6 · The paper itself

Abstract

objectiveLimited safety data have been published on fluorine-18 ( 18 F) meta-fluorobenzylguanidine ( m FBG), a new PET radiopharmaceutical for imaging neural crest and neuroendocrine tumors. As part of a prospective clinical trial, safety data in patients with neuroblastoma were collected and analyzed.

methodsBetween April 2015 and January 2022, 27 patients with neuroblastoma underwent 18 F- m FBG PET imaging as part of an ongoing single-center phase 1/2 trial (NCT02348749). Pre- and postinjection safety assessments were performed, including vital sign measurement and observation for occurrence of adverse events (AEs).

resultsm FBG administration resulted in no significant changes in measured vital signs. Two subjects had transient, grade 1 facial flushing shortly after the administration, which resolved within a few minutes. Neither subject had a clinically significant change in pulse or blood pressure on postadministration measurements.

conclusionIn this investigation of the potential clinical utility of m FBG PET imaging, no significant adverse safety signals were noted. Two mild, self-limited AEs were observed, without associated changes in vital signs. No grade 2 or higher AEs were noted. The findings are consistent with a favorable safety profile for m FBG in the target population of patients with neuroblastoma.

Indexed as

Fluorine RadioisotopesNeuroblastomaPositron-Emission TomographySafetyAdolescentChildChild, PreschoolFemaleHumansInfantMaleFluorine Radioisotopes

Identifiers

PMID39641193
PMCPMC12507052

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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.