Quantitative Margin Assessment Using High-resolution Positron Emission Tomography - Computed Tomograhy

Sponsor
University Medical Center Groningen
Study ID
NCT06726512
Status
Not Yet Recruiting

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Conditions

  • Oral Cancer
  • Oral Squamous Cell Carcinoma (OSCC)
  • Osteosarcoma
  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • XEOS AURA 10 — DEVICE
    Surgery is performed according to standard of care. Directly after surgery, the surgical specimen is taken outside the operation theatre in a dedicated imaging room at the Department of Nuclear Medicine where high-resolution PET-CT imaging of the surgical specimen is performed.

Study Details

The primary endpoint is the assessment of the clinical value of a novel high-resolution mobile PET-CT scanner for intraoperative margin assessment in oral squamous cell carcinoma, soft tissue sarcoma and osteosarcoma surgery. The predicted margin status will be correlated with the margin status determined with histopathology.

Key Dates

First listed
Dec 10, 2024
Start date
Jan 31, 2025
Status verified
Dec 2024
Primary completion
Oct 31, 2025
Completion
Apr 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: 2 MBq 18F-FDG
    Subjects are intravenously administered with 2.0 MBq/kg 18F-FDG, standard tracer used to diagnose and stage the malignancy. After standard of care excision of the primary tumor, a high-resolution PET-CT imaging of the fresh surgical specimen will be performed.

Primary Outcome Measure

The primary endpoint is to determine the margin detection rates of a novel high-resolution mobile PET-CT for intraoperative margin assessment in OSCC, STS, and OS surgery. [ Time Frame: Postoperatively i.e. 7-10 working days ]

Central Contacts

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