FDG-PET/CT Incidental Detection of Cancer in Patients Investigated for Infective Endocarditis
Authors: Gilbert Habib
Sandrine Hubert
Hubert Lepidi
Alberto Riberi
Jean-Paul Casalta
Didier Raoult
Hervé Tissot-Dupont
Frédérique Gouriet
Serge Cammilleri
Journal: Frontiers in medicine (2020)
Discipline: CLINICAL MEDICINE
Keywords: PET/CT; cancer; diagnosis; incidental; infective endocarditis.
Affiliations: Aix Marseille Univ, IRD, AP-HM, MEPHI, Marseille, France., IHU Méditerranée Infection, Marseille, France., Service de Cardiologie, Hôpital de la Timone, Marseille, France., Service de Médecine Nucléaire Hôpital de la Timone, Marseille, France., Service de Chirurgie Cardiaque, Hôpital de la Timone, Marseille, France.

Abstract:  Background: Fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) is an imaging technique largely used in the management of infective endocarditis and in the detection and staging of cancer. We evaluate our experience of incidental cancer detection by PET/CT during IE investigations and follow-up. Methods and Findings: Between 2009 and 2018, our center, which includes an "endocarditis team," managed 750 patients with IE in a prospective cohort. PET/CT became available in 2011 and was performed in 451 patients. Incidental diagnosis of cancer by PET/CT was observed in 36 patients and confirmed in 34 of them (7.5%) (colorectal n = 17; lung n = 7; lymphoma n = 2; melanoma n = 2; ovarian n = 2; prostate n = 1; bladder n = 1; ear, nose, and throat n = 1; brain n = 1). A significant association has been found between colorectal cancer and Streptococcus gallolyticus and/or Enterococcus faecalis [12/26 vs. 6/33 for other cancers, p = 0.025, odds ratio = 3.86 (1.19-12.47)]. Two patients had a negative PET/CT (a colon cancer and a bladder cancer), and two patients, with positive PET/CT, had a benign colorectal tumor. PET/CT had a sensitivity of 94-100% for the diagnosis of cancer in this patient. Conclusions: Whole-body PET/CT confirmed the high incidence of cancer in patients with IE and could now be proposed in these cases. 

Retracted: No

PubPeer comments:
 The paper describes a study in 750 patients with IE. Patients have been enrolled in a prospective cohort between 2009 and 2018. FDG PET CT became available in 2011 and was performed in 451 patients. This is an interventional prospective study in patients using a radiopharmaceutical products from 2011. The authors wrote:  The studies involving human participant were reviewed and approved by the Comitu00e9 de Protection des Personnes Sud-Mu00e8diterranu00e9e II with the number EudraCT: 2012-A01549-34 . However, there is no mention of this study or this number in the EudraCT for public audience. See : https: www.clinicaltrialsregister.eu ctr-search search?query=2012-A01549-34 In ClinicalTrials.gov, this study is also registered and mentionned the same number 2012-A01549-34. But it can be noted several discrepancies: https: clinicaltrials.gov ct2 show NCT02816307 **Discrepancy #1** 2012-A01549-34 is referred as a ANSM number. Using a radiopharmaceutical products in an interventional prospective study can be considered as a clinical trials under the EU Clinical Trials Directive. In this case, the study needs to be registered on EudraCT. Can the authors confirm that this study has been registered in EudraCT and provide the EudraCT number ? If the study has not been registered in EudraCT, can the authors explain why they consider this study didn t fall under the EU Clinical Trials Directive ? **Discrepancy #2** The ClinicalTrials.gov record mention that the study started in March 2013 and not in 2009. And the study ended in September 2019. Furthermore, the protocol number is noted as 2012-39. The study start date (2013), the protocol number (2012) and the ANSM number ( 2012-A01549-34) raised a serious concern. **Did the author get a retrospective ethics approval ?** Considering that the ANSM number has been delivered in 2012, that the protocol number is 2012-39, we can guess with a good confidence that the ethics approval delivered by the Comitu00e9 de Protection des Personnes has been delivered in or after 2012. However, the authors mentioned a recruitment starting in 2009. The authors need to clarify asap the ethical approval process and explain the discrepancies found between ClinicalTrials.gov and their article. It should be noted that a retrospective ethics committee approval for a prospective interventional study is a serious breach of the Helsinki Declaration. In accordance with Editors guidances and Helsinki Declaration, if a prospective study has not been granted ethics committee approval prior to commencing, retrospective ethics approval cannot be obtained and it may not be possible to consider the manuscript for peer review. Accepting retrospective ethics approval for interventional prospective study would promote these practices and this risk should be considered very seriously by Editors. Otherwise, this ANSM number is used to justify the ethics approval of 2 others papers describing different type of protocols and different types of objectives. Can the authors explain precisely what cover the protocol 2012-A01549-34? [Western Immunoblotting for the Diagnosis of Enterococcus faecalis and Streptococcus gallolyticus Infective Endocarditis] [A novel and sensitive real-time PCR system for universal detection of poxviruses] ,