Evidence map›Paper›PMID 30741441›Full record

ReviewJournal of labelled compounds & radiopharmaceuticals2019

Clinical translation of theranostic radiopharmaceuticals: Current regulatory status and recent examples.

Petra Kolenc Peitl, Christine Rangger, Piotr Garnuszek, Renata Mikolajczak, Alicja Hubalewska-Dydejczyk, Theodosia Maina, Paola Erba, Clemens Decristoforo

Open access · hybridAbstract readReview
In one paragraph

Review in Journal of labelled compounds & radiopharmaceuticals, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
4.8field-weighted citation impact, top 5% 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.

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

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Hyperpolarized MRI theranostics in cancer.Frontiers in oncology · 2025
    Article
  6. Review
  7. Review
  8. EANM guidance document: dosimetry for first-in-human studies and early phase clinical trials.European journal of nuclear medicine and molecular imaging · 2024
    Article
  9. Review
  10. Radiochemical and Biological Evaluation of 3p-Pharmaceuticals (Basel, Switzerland) · 2023
    Article
  11. Article
  12. Review
  13. One stone, many birds: Recent advances in functional nanogels for cancer nanotheranostics.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology · 2022
    Review
  14. Article
  15. Article
  16. Cold Kit Labeling: The Future ofFrontiers in medicine · 2022
    Review
  17. Radiopharmaceutical Formulation and Preclinical Testing ofPharmaceuticals (Basel, Switzerland) · 2021
    Article
  18. Article
  19. Review
  20. 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

8 authors at 6 institutions in 5 countries.

Petra Kolenc PeitlDeparment of Nuclear Medicine, University Medical Centre Ljubljana, Ljubljana, Slovenia.
Christine RanggerDepartment of Nuclear Medicine, Medical University Innsbruck, Innsbruck, Austria.
Piotr GarnuszekRadioisotope Centre POLATOM, National Centre for Nuclear Research, Otwock, Poland.
Renata MikolajczakRadioisotope Centre POLATOM, National Centre for Nuclear Research, Otwock, Poland.ORCID 0000-0002-6882-751X
Alicja Hubalewska-DydejczykChair and Department of Endocrinology, Jagiellonian University Medical College, Krakow, Poland.
Theodosia MainaMolecular Radiopharmacy, INRASTES, NCSR "Demokritos", Athens, Greece.ORCID 0000-0002-1123-2486
Paola ErbaNuclear Medicine, Department of Translational Research and New Technologies in Medicine University of Pisa and Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
Clemens DecristoforoDepartment of Nuclear Medicine, Medical University Innsbruck, Innsbruck, Austria.ORCID 0000-0003-0566-4036
Innsbruck Medical University · ATNational Centre for Nuclear Research · PLJagiellonian University · PLLjubljana University Medical Centre · SINational Centre of Scientific Research "Demokritos" · GRUniversity of Pisa · IT

Funding

Austrian Science Fund I1224-B19Austrian Science Fund FWF I 1224European Commission under the Seventh Framework Programme (FP7)Federal Ministry of Education and Research (BMBF), GermanyGeneral Secretariat for Research and Technology, Ministry of Education, Life Long Learning and Religious Affairs (GSRT), GreeceMinistry of Health (MoH), ItalyMinistry of Higher Education, Science and Technology (MHEST), SloveniaNational Centre for Research and Development (NCBiR), Poland
6 · The paper itself

Abstract

With the development of ever more radiopharmaceuticals suitable for theranostic applications, translation of novel compounds from the preclinical stage towards clinical application becomes a bottleneck for the advances in Nuclear Medicine. This review article summarizes the current regulatory framework for clinical trials with radiopharmaceuticals in the European Union, provides a general overview of the documentation required, and addresses quality, safety, and clinical aspects to be considered. By using a recent successful example of translating a theranostic peptide radioligand, namely

Indexed as

Social Control, FormalAnimalsDocumentationHumansQuality ControlRadiopharmaceuticalsTranslational Research, BiomedicalRadiopharmaceuticals111In-CP04clinical trialpeptide radiopharmaceuticalsregulatory frameworktheranostics nuclear medicine

Identifiers

PMID30741441
PMCPMC6767129
OpenAlexW2911888005

What OpenQuestion holds

Textmetadata
LicenceTDM
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 OpenQuestion graph.