Evidence map›Paper›PMID 38366197›Full record

ArticleEuropean journal of nuclear medicine and molecular imaging2024

EANM guidance document: dosimetry for first-in-human studies and early phase clinical trials.

Caroline Stokke, Silvano Gnesin, Johannes Tran-Gia, Francesco Cicone, Søren Holm, Marta Cremonesi, Johan Blakkisrud, Thomas Wendler, Nic Gillings, Ken Herrmann and 2 more

Abstract read
In one paragraph

Article 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. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

26 citing papers in PubMed.

  1. First-in-human dosimetry and biodistribution of [European journal of nuclear medicine and molecular imaging · 2026
    Article
  2. Normal Tissue Dosimetry of IntraperitonealJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026
    Article
  3. Detailed pharmacokinetic features of a novel bis-boronEuropean journal of nuclear medicine and molecular imaging · 2026
    Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Future of radiotheranostics.BMJ oncology · 2026
    Review
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Organ and tumour dosimetry ofEuropean journal of nuclear medicine and molecular imaging · 2025
    Article
  18. Review
  19. Article
  20. First-in-Human Phase 0 Study of AB001, a Prostate-Specific Membrane Antigen-TargetedJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2025
    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

12 authors.

Caroline StokkeDepartment of Diagnostic Physics and Computational Radiology, Division of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway. carsto@ous-hf.no.ORCID 0000-0003-4465-9635
Silvano GnesinInstitute of Radiation Physics, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Johannes Tran-GiaDepartment of Nuclear Medicine, University Hospital Würzburg, Würzburg, Germany.ORCID 0000-0001-9552-7750
Francesco CiconeNuclear Medicine Unit, Department of Experimental and Clinical Medicine, "Magna Graecia" University of Catanzaro, Catanzaro, Italy.ORCID 0000-0003-4664-1965
Søren HolmDepartment of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0001-9524-0717
Marta CremonesiDepartment of Medical Imaging and Radiation Sciences, European Institute of Oncology, IRCCS, Milan, Italy.
Johan BlakkisrudDepartment of Diagnostic Physics and Computational Radiology, Division of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.
Thomas WendlerComputer-Aided Medical Procedures and Augmented Reality, Technische Universität München, Munich, Germany.ORCID 0000-0002-0915-0510
Nic GillingsDepartment of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0002-7669-2344
Ken HerrmannDepartment of Nuclear Medicine, University of Duisburg-Essen, and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany.
Felix M MottaghyDepartment of Radiology and Nuclear Medicine, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.ORCID 0000-0002-7212-6521
Jonathan GearJoint Department of Physics, Royal Marsden NHSFT & Institute of Cancer Research, Sutton, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The numbers of diagnostic and therapeutic nuclear medicine agents under investigation are rapidly increasing. Both novel emitters and novel carrier molecules require careful selection of measurement procedures. This document provides guidance relevant to dosimetry for first-in human and early phase clinical trials of such novel agents. The guideline includes a short introduction to different emitters and carrier molecules, followed by recommendations on the methods for activity measurement, pharmacokinetic analyses, as well as absorbed dose calculations and uncertainty analyses. The optimal use of preclinical information and studies involving diagnostic analogues is discussed. Good practice reporting is emphasised, and relevant dosimetry parameters and method descriptions to be included are listed. Three examples of first-in-human dosimetry studies, both for diagnostic tracers and radionuclide therapies, are given.

Indexed as

Nuclear MedicineRadiopharmaceuticalsClinical Trials as TopicHumansPractice Guidelines as TopicRadiometryRadionuclide ImagingRadiopharmaceuticalsDosimetryEuropean Association of Nuclear MedicineFirst-in-humanNuclear medicineRadiopharmaceuticals

Identifiers

PMID38366197
PMCPMC10957710

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 Socratic graph.