Evidence map›Paper›PMID 31111397›Full record

ArticleMolecular imaging and biology2020

Preclinical Safety Evaluation and Human Dosimetry of [

Michel Koole, Talakad G Lohith, John L Valentine, Idriss Bennacef, Ruben Declercq, Tom Reynders, Kerry Riffel, Sofie Celen, Kim Serdons, Guy Bormans and 9 more

Registry-linked trialAbstract readEvaluation Study
PubMed Publisher
In one paragraph

Article in Molecular imaging and biology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04437290 (University of Washington Alzheimer's Disease Research Center), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 12% 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.

NCT04437290 unknown statusnot on this mapstarted 2022, after this paper: background citation

University of Washington Alzheimer's Disease Research Center (UW ADRC) Imaging & Biomarker Core

TypeobservationalSponsorUniversity of WashingtonRan2022 to 2025Enrolled300ConditionsAlzheimer DiseaseArmsinvestigational radiotracer [18F]MK6240
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Prediction of longitudinal synaptic loss in Alzheimer's disease using tau PET and plasma biomarkers.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
    Article
  4. Article
  5. Article
  6. Test-retest performance of [Imaging neuroscience (Cambridge, Mass.) · 2024
    Article
  7. Article
  8. Review
  9. Article
  10. A Visual Interpretation Algorithm for Assessing Brain Tauopathy withJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2023
    Article
  11. Review
  12. Dosimetry and efficacy of a tau PET tracer [Annals of nuclear medicine · 2023
    Article
  13. Impact of meningeal uptake and partial volume correction techniques on [Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism · 2022
    Article
  14. 18F-MK-6240 tau-PET in genetic frontotemporal dementia.Brain : a journal of neurology · 2022
    Article
  15. Review
  16. Novel Tracers and Radionuclides in PET Imaging.Radiologic clinics of North America · 2021
    Review
  17. Biodistribution and Dosimetry Evaluation for a Novel Tau Tracer [Frontiers in bioengineering and biotechnology · 2021
    Article
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

19 authors at 6 institutions in 3 countries.

Michel KooleDivision of Nuclear Medicine, Leuven University Hospitals and UZ Leuven, Leuven, Belgium.
Talakad G LohithTranslational Imaging Biomarkers, Merck & Co., Inc., 770 Sumneytown Pike, Mailstop WP44D-216, West Point, PA, 19486, USA. talakad.lohith@merck.com.
John L ValentineSafety Assessment and Laboratory Animal Research, Merck & Co., Inc., West Point, PA, USA.
Idriss BennacefTranslational Imaging Biomarkers, Merck & Co., Inc., 770 Sumneytown Pike, Mailstop WP44D-216, West Point, PA, 19486, USA.
Ruben DeclercqTranslational Pharmacology Europe, Merck Sharp & Dohme Inc., Brussels, Belgium.
Tom ReyndersTranslational Pharmacology Europe, Merck Sharp & Dohme Inc., Brussels, Belgium.
Kerry RiffelTranslational Imaging Biomarkers, Merck & Co., Inc., 770 Sumneytown Pike, Mailstop WP44D-216, West Point, PA, 19486, USA.
Sofie CelenRadiopharmaceutical Research, KU Leuven, Leuven, Belgium.
Kim SerdonsDivision of Nuclear Medicine, Leuven University Hospitals and UZ Leuven, Leuven, Belgium.
Guy BormansRadiopharmaceutical Research, KU Leuven, Leuven, Belgium.
Sandrine Ferry-MartinSafety Assessment and Laboratory Animal Research, Merck Sharp & Dohme, Riom, France.
Philippe LaroqueSafety Assessment and Laboratory Animal Research, Merck Sharp & Dohme, Riom, France.
Abbas WaljiDiscovery Chemistry, Merck & Co., Inc., West Point, PA, USA.
Eric D HostetlerTranslational Imaging Biomarkers, Merck & Co., Inc., 770 Sumneytown Pike, Mailstop WP44D-216, West Point, PA, 19486, USA.
Richard J BriscoeSafety Assessment and Laboratory Animal Research, Merck & Co., Inc., West Point, PA, USA.
Jan de HoonCenter for Clinical Pharmacology, University Hospitals of Leuven, Leuven, Belgium.
Cyrille SurTranslational Imaging Biomarkers, Merck & Co., Inc., 770 Sumneytown Pike, Mailstop WP44D-216, West Point, PA, 19486, USA.
Koen Van LaereDivision of Nuclear Medicine, Leuven University Hospitals and UZ Leuven, Leuven, Belgium.
Arie StruykTranslational Pharmacology, Merck & Co., Inc., North Wales, PA, USA.
United States Military Academy · USKU Leuven · BEUniversitair Ziekenhuis Leuven · BEMSD (Belgium) · BEMSD (France) · FRMerck & Co., Inc., Rahway, NJ, USA (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purpose[ PROCEDURES: MK-6240 was administered intravenously (IV) in a 7-day rat toxicity study at × 50, × 100, and × 1000 dose margins relative to projected highest clinical dose of 0.333 μg/kg. The IV formulation of MK-6240 for clinical use and the formulation used in the 7-day rat toxicity study was tested for hemolysis potential in human and Wistar rat whole blood. Sequential whole-body positron emission tomography scans were performed in three healthy young subjects after IV bolus injection of 180 ± 0.3 MBq [

resultsMK-6240 administered IV in a 7-day rat toxicity study did not show any test article-related changes. The no-observed-adverse-effect level in rats was ≥ 333 μg/kg/day which provides a margin 1000-fold over an anticipated maximum clinical dose of 0.333 μg/kg. Additionally, the MK-6240 formulation was not hemolytic in human or Wistar rat blood. [

conclusionsMicrodoses of [

Indexed as

Alzheimer DiseaseAnimalsFemaleFluorine RadioisotopesHealthy VolunteersHumansIsoquinolinesMaleNeurofibrillary TanglesPatient SafetyPositron Emission Tomography Computed TomographyRadiometryRadiopharmaceuticalsRatsRats, WistarTissue DistributionFluorine-18Fluorine RadioisotopesIsoquinolinesMK-6240Radiopharmaceuticals[18F]MK-6240Alzheimer diseaseBiodistributionCognitive declineHuman whole-body imagingNeurofibrillary tanglesRadiation dosimetry

Identifiers

PMID31111397
OpenAlexW2945507791

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.