Performance of 18F-FDG Micro-PET-CT in the Assessment of Surgical Margins in Head and Neck Cancer
NCT ID: NCT07285564
Last Updated: 2025-12-16
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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RECRUITING
NA
10 participants
INTERVENTIONAL
2025-11-07
2026-06-15
Brief Summary
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Detailed Description
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The objective is therefore to evaluate the performance of another tool, available intraoperatively, to help surgeons assess the quality of their resection. Currently, micro-PET-CT allows for the evaluation of surgical specimens (CE marking and FDA approval obtained). Its performance in the evaluation of surgical margins remains to be demonstrated. This is the subject of the present study.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Experimental
PET/CT of the specimen after surgery
micro PET/CT
PET/T of the speciment after surgery
Interventions
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micro PET/CT
PET/T of the speciment after surgery
Eligibility Criteria
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Inclusion Criteria
* Adult, male or female, aged 18 or over
* Patient with a malignant tumor of the oral cavity, oropharynx, hypopharynx, larynx, sinuses, or salivary glands, regardless of lymph node status (any N) M0, operable
* Member or beneficiary of a social security plan
Exclusion Criteria
* Patients under guardianship, conservatorship, or legal protection
* Patients deprived of their liberty
* Pregnant or breastfeeding women
* Hypersensitivity to 18F-FDG or any of its excipients (ethanol or water for injection)
* Uncontrolled diabetes
* Moderate to end-stage renal failure, stage IIIB to V (glomerular filtration rate less than 44 mL/min/1.73 m²)
* Patients unable to understand the study for any reason or to comply with the trial requirements (language, psychological, or geographical issues).
18 Years
ALL
No
Sponsors
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Centre Henri Becquerel
OTHER
Responsible Party
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Principal Investigators
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Sebastien Hapdey, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Henri Becquerel
Lise-Marie Roussel, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Henri Becquerel
Locations
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Centre Henri Becquerel
Rouen, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHB25.06
Identifier Type: -
Identifier Source: org_study_id