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

NCT03877900 | Completed

• 1 other identifier: P/2018/394
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stillbirth and Fetal Death; Termination of Pregnancy; Neonatal Death

Keywords

post mortem Magnetic Resonance Imaging; stillbirth; fetal death; neonatal death; Minimally Invasive Autopsy; Tissue samplings

Outcome Measures

Primary Outcomes (1)

• Number of virtopsy made completely

  Number of virtopsy made completely (from death until clinical report).

  month 12

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

* stillbirth and fetal deaths over 21 weeks of gestation * termination of pregnancy over 21 weeks of gestation * neonatal death

You may qualify if:

• 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.

You may not qualify if:

• legal incapacity
• limited ability to consent
• lack of parental consent

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU Besancon

Besançon, 25030, France

Location

Related 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.

  PMID: 24288400 BACKGROUND

• 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. doi: 10.1016/S0140-6736(96)02287-8.

  PMID: 8888168 BACKGROUND

• 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.

  PMID: 20878677 BACKGROUND

• 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.

  PMID: 28116518 BACKGROUND

• 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.

  PMID: 21919100 BACKGROUND

• 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. doi: 10.1016/S0140-6736(05)74816-9.

  PMID: 15811461 BACKGROUND

• 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.

  PMID: 21740313 BACKGROUND

• 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. doi: 10.2214/ajr.168.1.8976917.

  PMID: 8976917 BACKGROUND

• 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.

  PMID: 22192497 BACKGROUND

• 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.

  PMID: 29869137 BACKGROUND

MeSH Terms

Conditions

Stillbirth; Fetal Death; Perinatal Death

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marion AUBER LENOIR, MD

  CHU Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: February 28, 2019
• Primary Completion: March 6, 2020
• Study Completion: March 6, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)