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Clinical and Translational Imaging

, Volume 7, Issue 1, pp 7–20 | Cite as

HTA in nuclear medicine: [68Ga]PSMA PET/CT for patients with prostate cancer

  • Lorena PozzoEmail author
  • Lucilena Rebelo Monteiro
  • Juliano Julio Cerci
  • Stefano Fanti
  • Antonella Negro
  • Evelinda Trindade
Systematic Review
  • 106 Downloads
Part of the following topical collections:
  1. Health technology assessment

Abstract

The [68Ga]PSMA PET/CT has been an option on clinical research tools to stage and to restage prostate cancer patients, although, with promising results, this radiopharmaceutical cannot be commercialized yet. Hence, up to date, [68Ga]PSMA has been used in a clinical research context. Once regulatory body approved it for marketing, health systems are responsible for the reimbursement decision. Health Technology Assessments (HTA) tools should be considered to base and to help decision-makers to spread or not this new technology. Regarding [68Ga]PSMA, under HTA framework, the present study searched for secondary studies and hence assessed three systematic reviews with meta-analyses published considering prostate cancer patients in different scenarios, same imaging technology but different comparators and outputs. The secondary studies considered outputs such as accuracy, detectability, positivity and change of management. Using AMSTAR-2, the meta-analysis methods and results were evaluated with 16 questions able to identify critical weaknesses, such as risk of bias, publication bias, true effect, and study heterogeneity. To increase the observational number of patients, to register positive and negative findings, and consolidate regional and multi-center clinical data which were suggestions on study design, structure and statistics made to improve the quality in future primary and secondary studies.

Keywords

Meta-analysis HTA [68Ga]PSMA 

Abbreviations

[18F]FDG

18F-fluorodeoxyglucose

AMSTAR

A measurement tool to assess systematic reviews

BS

Bone scan

BCR

Biochemical recurrence

EANM

European association of nuclear medicine

EAU

European association of urology

[18F]FACB

18F-fluorocyclobutane-1-carboxylic acid

FDA

Food and drug administration

GRADE

Grading of recommendations assessment, development and evaluation

HTA

Health technology assessment

MRI

Magnetic resonance imaging

PRISMA

Preferred reporting items for systematic review and meta-analysis

PICO

Population, intervention, comparator, outcome

PSA

Prostate specific antigen

PSMA

Prostate-specific membrane antigen

QUADAS-2

Quality assessment of diagnostic accuracy studies

RoB

Risk of bias

SNMMI

Society of nuclear medicine and molecular imaging

SR/MA

Systematic review and meta-analysis

Notes

Acknowledgements

The authors would like to thank IPEN—CNEN/SP and University of Bologna for the possibility of carrying out this collaborative work. This work was possible also due to the collaboration with the Agenzia Sanitaria e Sociale Regionale Regione Emilia-Romagna and the authors would like to thank especially Dr. Susanna Maltoni for make this possible and Maria Camerlingo for the valuable help during the bibliographic search.

Author contributions

LP was responsible for conception, search and data extraction, analysis, writing, and revision. LRM was responsible for statistical analysis evaluation, writing, and revision. JJC and SF were responsible for clinical discussion and revision. ET was responsible for study selection and revision. AN was responsible for HTA discussion and revision.

Funding

Authors report no special funding for this work.

Compliance with ethical standards

Conflict of interests

None.

Availability of data and materials

Not applicable.

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Copyright information

© Italian Association of Nuclear Medicine and Molecular Imaging 2019

Authors and Affiliations

  1. 1.Instituto de Pesquisas Energéticas e NuclearesSão PauloBrazil
  2. 2.Quanta Diagnóstico NuclearCuritibaBrazil
  3. 3.Department of Experimental, Diagnostic and Specialty MedicineUniversity of BolognaBolognaItaly
  4. 4.Agenzia Sanitaria e Sociale Regionale Regione Emilia-RomagnaBolognaItaly
  5. 5.Coordenadoria de Ciência, Tecnologia e Inovação em Saúde, Núcleo de Avaliação de Tecnologia da SaúdeSecretatia de Saúde do Estado de São PauloSao PauloBrazil

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