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[18F]Fluciclovine PET/CT: joint EANM and SNMMI procedure guideline for prostate cancer imaging—version 1.0

Abstract

The aim of this guideline is to provide standards for the recommendation, performance, interpretation, and reporting of [18F]Fluciclovine PET/CT for prostate cancer imaging. These recommendations will help to improve accuracy, precision, and repeatability of [18F]Fluciclovine PET/CT for prostate cancer essentially needed for implementation of this modality in science and routine clinical practice.

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Acknowledgements

“The guidelines were brought to the attention of SNMMI, the relevant EANM Committees and the National Societies of Nuclear Medicine. The comments and suggestions from SNMMI, the EANM Oncology, Bone and Joint, Radiopharmacy, Neurology, Inflammation and Infection and Dosimetry Committees and the German and Spanish National Societies are highly appreciated and have been considered for this Guideline.”

Author information

Correspondence to Cristina Nanni.

Ethics declarations

Conflict of interest

Cristina Nanni provided consultancy for Blue Earth Diagnostics Ltd. 2018–1019. She was Principal Investigator of the project entitled ANTI-3-18F-FACBC (anti1-amino-3-18F-fluorocyclobutane-1-carboxylic acid) in comparison to 11c-choline PET/CT in the evaluation of patients with prostate cancer radically treated and with rising PSA, "Programma di ricerca Regione- Università 2013-Area 1 "Ricerca Innovativa", Bando "Alessandro Liberati"-Giovani Ricercatori".

Lucia Zanoni had a scientific-only relationship with the company “Blue Earth Diagnostics Ltd.” as Medical Staff of the Sponsored Study BED001 (118/2014/O/Oss), (no financial relationship, no compensation received). Lucia Zanoni was Principal Investigator of the project entitled “18F-FACBC PET/CT for staging high risk prostate cancer” funded by “Programma di ricerca Regione- Università 2013-Area 1 “Ricerca Innovativa”, Bando “Alessandro Liberati-Giovani Ricercatori”. In the context of this project, Lucia Zanoni received a granted 1-year SSN contract as nuclear medicine project manager (both scientific and financial relationship)

Tore Bach-Gansmo is a consultant for BED, and the hospital has received research funding from BED.

Heikki Minn institution (Turku University Hospital) has a research contract with Blue Earth Diagnostics (not related to fluciclovine).

Frode Willoch has provided consultancy for Blue Earth Diagnostics Ltd. 2016–2017.

Trond Velde Bogsrud received research funding from Blue Earth Diagnostics Ltd, marketer of 18F-fluciclovine (Axumin), to Oslo University Hospital, Oslo, Norway, for clinical studies using 18F-fluciclovine PET/CT in prostate cancer performed together with Bach-Gansmo T.

Ephraim Parent participates in research funded in part by Blue Earth Diagnostics.

Bital Savir-Baruch had grant support by Blue Earth Diagnostics.

Dr. Eugene Teoh was a consultant to Blue Earth Diagnostics and affiliated to Oxford University, at time of contribution to the published work. At time of subsequent publication, Dr. Eugene Teoh is an employee of Blue Earth Diagnostics.

Fenton Ingram RT(R), CNMT, PET has no financial or non-financial conflict of interest to declare.

Stefano Fanti, with respect to the mentioned paper, declares that he attended an advisory board of Blue Earth Diagnostics in 2014 and in 2015.

David Schuster is a Consultant in Syncona, AIM Specialty Health, and participated through the Emory Office of Sponsored Projects in sponsored grants including those funded or partially funded by Blue Earth Diagnostics, Ltd.; Nihon MediPhysics Co, Ltd.; Telix Pharmaceuticals (USA) Inc.; Advanced Accelerator Applications; and FUJIFILM Pharmaceuticals USA, Inc.

Human and animal rights and informed consent

There are no human or animal participants in the study.

Informed consent

This is a procedural guideline so no informed consent was necessary.

Additional information

Liability statement

“This guideline summarizes the views of the EANM Oncology, Bone and Joint Committee, Radiopharmacy, Neurology, Inflammation and Infection and Dosimetry Committees and SNMMI. It reflects recommendations for which the EANM cannot be held responsible. The recommendations should be taken into context of good practice of nuclear medicine and do not substitute for national and international legal or regulatory provisions”

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This article is part of the Tropical Collection on Oncology – Genitourinary

Preamble

The Society of Nuclear Medicine and Molecular Imaging (SNMMI) is an international non-profit scientific and professional organization founded in 1954 to promote the science, technology, and practical application of nuclear medicine. The European Association of Nuclear Medicine (EANM) is a professional nonprofit medical association that facilitates communication worldwide between individuals pursuing clinical and research excellence in nuclear medicine. The EANM was founded in 1985. SNMMI and EANM members are physicians, technologists, and scientists specializing in the research and practice of nuclear medicine.

The SNMMI and EANM will periodically define new guidelines for nuclear medicine practice to help advance the science of nuclear medicine and to improve the quality of service to patients throughout the world. Existing practice guidelines will be reviewed for revision or renewal, as appropriate, on their fifth anniversary or sooner, if indicated.

Each practice guideline, representing a policy statement by the SNMMI/EANM, has undergone a thorough consensus process in which it has been subjected to extensive review.

The SNMMI and EANM recognize that the safe and effective use of diagnostic nuclear medicine imaging requires specific training, skills, and techniques, as described in each document. Reproduction or modification of the published practice guideline by those entities not providing these services is not authorized.

These guidelines are an educational tool designed to assist practitioners in providing appropriate care for patients. They are not inflexible rules or requirements of practice and are not intended, nor should they be used, to establish a legal standard of care. For these reasons and those set forth below, both the SNMMI and the EANM caution against the use of these guidelines in litigation in which the clinical decisions of a practitioner are called into question. The ultimate judgment regarding the propriety of any specific procedure or course of action must be made by the physician or medical physicist in light of all the circumstances presented. Thus, there is no implication that an approach differing from the guidelines, standing alone, is below the standard of care. To the contrary, a conscientious practitioner may responsibly adopt a course of action different from that set forth in the guidelines when, in the reasonable judgment of the practitioner, such course of action is indicated by the condition of the patient, limitations of available resources, or advances in knowledge or technology subsequent to publication of the guidelines.

The practice of medicine includes both the art and the science of the prevention, diagnosis, alleviation, and treatment of disease. The variety and complexity of human conditions make it impossible to always reach the most appropriate diagnosis or to predict with certainty a particular response to treatment. Therefore, it should be recognized that adherence to these guidelines will not ensure an accurate diagnosis or a successful outcome. All that should be expected is that the practitioner will follow a reasonable course of action based on current knowledge, available resources, and the needs of the patient to deliver effective and safe medical care. The sole purpose of these guidelines is to assist practitioners in achieving this objective.

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Nanni, C., Zanoni, L., Bach-Gansmo, T. et al. [18F]Fluciclovine PET/CT: joint EANM and SNMMI procedure guideline for prostate cancer imaging—version 1.0. Eur J Nucl Med Mol Imaging 47, 579–591 (2020). https://doi.org/10.1007/s00259-019-04614-y

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Keywords

  • [18F]Fluciclovine
  • PET
  • Prostate cancer
  • Staging
  • Restaging
  • Guideline