Quantitative Margin Assessment Using High-resolution Positron Emission Tomography - Computed Tomograhy
NCT ID: NCT06726512
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-01-31
2026-04-30
Brief Summary
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Detailed Description
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The investigators propose a dedicated intraoperative high-resolution PET-CT (positron emission tomography - computed tomography) imaging system for margin assessment of the excised specimen. The proposed specimen imaging system would combine the proven functional imaging capabilities of PET with the anatomical imaging info of CT, providing multi-modal information to determine whether tumor cells are present at the excision edges of the specimen. The tomographic images obtained can precisely demonstrate tumor extension along the x, y, and z axis, and the PET signal is not distorted by bone tissue. PET is the most sensitive medical imaging modality capable of detecting the picomolar concentrations of radiotracer, allowing to assess the presence of tumor cells within the specimen margins with high precision. Current standard PET-CT scanners have a spatial resolution between 3mm and 6mm, which is insufficient to accurately assess the excision margins of tumors. A specimen imaging system ideally should have a sub-millimeter resolution. The specimen PET system which will be used in this study is capable of this. The potential of intraoperative PET-CT has been shown in several tumor types, enabling the intraoperative identification of PSMs in prostatectomy and lumpectomy specimens.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
XEOS AURA 10
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.
Interventions
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XEOS AURA 10
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient is confirmed with oral squamous cell carcinoma, soft tissue sarcoma or osteosarcoma.
* Patient is indicated to undergo curative surgery of the primary tumor.
* Patient is estimated compliant for study participation by the investigator.
* Written informed consent.
Exclusion Criteria
* Patient has previously received radiotherapy of the primary tumor region;
* Patient has participated in other clinical studies with radiation exposure of more than 1 mSv in the past 12 months;
* A blood glucose level over 200 mg/dL on the day of surgery.
* Pregnancy or lactation.
18 Years
ALL
No
Sponsors
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University Medical Center Groningen
OTHER
Responsible Party
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Locations
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University Medical Center Groningen
Groningen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Jasper Vonk, Dr
Role: primary
Rik de Jong
Role: backup
Other Identifiers
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NL86142.042.24
Identifier Type: -
Identifier Source: org_study_id