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48 VIMAP-trial: vulvar cancer intra-operative margin assessment using PET-CT – study protocol
  1. Anne-Sofie De Crem1,
  2. Philippe Tummers1,
  3. Rawand Salihi1,
  4. Amin Makar1,
  5. Glenn Vergauwen1,
  6. Koen Van De Vijver2,
  7. Pieter De Visschere3,
  8. Kathia De Man3,
  9. Donatienne Van Weehaeghe3,
  10. Katrien Vandecasteele4,
  11. Hannelore Denys5,
  12. Jens Debacker6 and
  13. Menekse Göker1
  1. 1Department of Obstetrics and Gynaecology, Ghent University Hospital, Ghent, Belgium
  2. 2Department of Pathology, Ghent University Hospital, Ghent, Belgium
  3. 3Department of Radiology and Nuclear Medicine, Ghent University Hospital, Ghent, Belgium
  4. 4Department of Radiotherapy, Ghent University Hospital, Ghent, Belgium
  5. 5Department of Medical Oncology, Ghent University Hospital, Ghent, Belgium
  6. 6Molecular Imaging and Therapy Research Group, Vrije Universiteit Brussel, Brussels, Belgium


Introduction/Background Vulvar cancer is a rare malignancy. Treatment in the early stages consists of a broad excision and sentinel node procedure. Tumour excision remains challenging due to the high risk of local recurrence (43%) associated with positive tumour margins. Therefore, a precise method to preserve healthy tissue and detect tumour positive margins intra-operatively, is needed. Direct intra-operative assessment would avoid the need for re-operation and their psychological, technical, and financial consequences. Currently, intra-operative margin assessment can only be done by frozen section, a technique not commonly used due to many disadvantages such as time-consuming, disruption of the workflow and interference with final assessment. In this study a submillimetric 3D Positron Emission Tomography – Computed Tomography (PET-CT) specimen imager, is introduced: a novel approach to assess tumour margins intra-operatively.

Methodology The aim of this open label pilot study is to test the feasibility of using a micro-PET-CT, the AURA 10 (XEOS, Ghent, Belgium), intra-operatively to visualize 18F-FDG-uptake in resected specimens obtained during vulvar surgery. Therefore, one single low-dose intravenous injection of 0.8 MBq/kg 18F-FDG is administered before surgery. The primary objective is to investigate the feasibility of the AURA 10 to detect positive excision margins. The margins on these images will be analysed by the surgeons and compared to the gold standard of sectional histopathological evaluation. The diagnostic performance will be reported in sensitivity, specificity and accuracy. If positive margins are suspected, the surgeon can immediately do a precise re-excision. The secondary objective is to investigate the ability to detect cancer cells in the sentinel lymph nodes. 30 patients will be included with vulvar cancer, vulvar intra-epithelial neoplasia (VIN) or Paget disease, who were eligible for vulvectomy.

Results /

Conclusion /

Disclosures None

Abstract 48 Figure 1

Intra-operative vulvectomy specimen scanning with the micro-PET-CT (AURA 10). A. CT image of the specimen in coronal plane. B. PET-CT image of the specimen in coronal plane. The scale of 18F-FDG uptake is shown beneath, red stands for high uptake whereas blue for low. C. PET-CT image of the specimen in sagittal plane. The specimen container is visible as a light grey circle (in A and B). S = superior, I = inferior, R= right, L=left, A=anterior and P=posterior

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