A Feasibility Study of Virtopsy With Tissue Sampling in Besancon University Hospital

Neonatal Death Clinical Trial

— VIRTOPSY+  

Official title:

A Feasibility Study of Virtopsy With Tissue Sampling in Besancon University Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03877900
• Other study ID #: P/2018/394
• Status: Completed
• Start date: February 28, 2019
• Est. completion date: March 6, 2020

Study information

• Verified date: October 2020
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of this project is to assess the feasibility of a new local post mortem procedure at Besançon University Hospital : Virtopsy+, magnetic resonance (MR) imaging with tissue sampling of the fetus and newborns.

Description:

Minimally invasive autopsy is an alternative for conventional autopsy including post mortem magnetic resonance (MR) imaging and tissues samplings.

Because of the raise of parental refusal of autopsy, we intend to assess the local feasibility of a minimally invasive autopsy approach using post mortem MR imaging of fetuses and newborns in order to detect the major pathological abnormalities and/or to determinate the cause of death.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 6, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Month

Eligibility

Inclusion Criteria:

• stillbirth and fetal deaths over 21 weeks of gestation

• termination of pregnancy over 21 weeks of gestation

• neonatal death

• patient having read the letter of information and signed the consent.

Exclusion Criteria:

• legal incapacity

• limited ability to consent

• lack of parental consent

Related Conditions & MeSH terms

• Death
• Fetal Death
• Neonatal Death
• Perinatal Death
• Stillbirth
• Stillbirth and Fetal Death
• Termination of Pregnancy

Locations

Country	Name	City	State
France	CHU Besancon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

References & Publications (10)

Addison S, Arthurs OJ, Thayyil S. Post-mortem MRI as an alternative to non-forensic autopsy in foetuses and children: from research into clinical practice. Br J Radiol. 2014 Apr;87(1036):20130621. doi: 10.1259/bjr.20130621. Review. — View Citation

Breeze AC, Jessop FA, Set PA, Whitehead AL, Cross JJ, Lomas DJ, Hackett GA, Joubert I, Lees CC. Minimally-invasive fetal autopsy using magnetic resonance imaging and percutaneous organ biopsies: clinical value and comparison to conventional autopsy. Ultrasound Obstet Gynecol. 2011 Mar;37(3):317-23. doi: 10.1002/uog.8844. — View Citation

Brookes JA, Hall-Craggs MA, Sams VR, Lees WR. Non-invasive perinatal necropsy by magnetic resonance imaging. Lancet. 1996 Oct 26;348(9035):1139-41. — View Citation

Cannie M, Votino C, Moerman P, Vanheste R, Segers V, Van Berkel K, Hanssens M, Kang X, Cos T, Kir M, Balepa L, Divano L, Foulon W, De Mey J, Jani J. Acceptance, reliability and confidence of diagnosis of fetal and neonatal virtuopsy compared with conventional autopsy: a prospective study. Ultrasound Obstet Gynecol. 2012 Jun;39(6):659-65. doi: 10.1002/uog.10079. Epub 2012 May 22. — View Citation

D'Hondt A, Cassart M, De Maubeuge R, Soto Ares G, Rommens J, Avni EF. Postmortem fetal magnetic resonance imaging: where do we stand? Insights Imaging. 2018 Aug;9(4):591-598. doi: 10.1007/s13244-018-0627-0. Epub 2018 Jun 4. Review. — View Citation

Griffiths PD, Paley MN, Whitby EH. Post-mortem MRI as an adjunct to fetal or neonatal autopsy. Lancet. 2005 Apr 2-8;365(9466):1271-3. — View Citation

Kang X, Cannie MM, Arthurs OJ, Segers V, Fourneau C, Bevilacqua E, Cos Sanchez T, Sebire NJ, Jani JC. Post-mortem whole-body magnetic resonance imaging of human fetuses: a comparison of 3-T vs. 1.5-T MR imaging with classical autopsy. Eur Radiol. 2017 Aug;27(8):3542-3553. doi: 10.1007/s00330-016-4725-4. Epub 2017 Jan 23. — View Citation

Sebire NJ, Weber MA, Thayyil S, Mushtaq I, Taylor A, Chitty LS. Minimally invasive perinatal autopsies using magnetic resonance imaging and endoscopic postmortem examination ("keyhole autopsy"): feasibility and initial experience. J Matern Fetal Neonatal Med. 2012 May;25(5):513-8. doi: 10.3109/14767058.2011.601368. Epub 2011 Aug 10. — View Citation

Thayyil S, Sebire NJ, Chitty LS, Wade A, Olsen O, Gunny RS, Offiah A, Saunders DE, Owens CM, Chong WK, Robertson NJ, Taylor AM. Post mortem magnetic resonance imaging in the fetus, infant and child: a comparative study with conventional autopsy (MaRIAS Protocol). BMC Pediatr. 2011 Dec 22;11:120. doi: 10.1186/1471-2431-11-120. — View Citation

Woodward PJ, Sohaey R, Harris DP, Jackson GM, Klatt EC, Alexander AL, Kennedy A. Postmortem fetal MR imaging: comparison with findings at autopsy. AJR Am J Roentgenol. 1997 Jan;168(1):41-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of virtopsy made completely	Number of virtopsy made completely (from death until clinical report).	month 12