Actively Recruiting
Performance of 18F-FDG Micro-PET-CT in the Assessment of Surgical Margins in Head and Neck Cancer
Led by Centre Henri Becquerel · Updated on 2025-12-16
10
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the diagnostic accuracy of 18F-FDG micro-PET-CT in identifying malignant head and neck cancers compared to the definitive histological analysis, which is considered the gold standard. This study addresses the challenge that about 20% of surgical margins are insufficient and that the current intraoperative tool, the extemporaneous examination, has a sensitivity of only 10%. The goal is to determine if micro-PET-CT can better assist surgeons during operations by assessing the quality of tumor removal. The study involves using micro-PET-CT imaging on the surgical specimens after the tumor removal surgery. This device is already approved for evaluating surgical specimens but its performance in assessing surgical margins in head and neck cancer needs to be demonstrated. The imaging takes place after surgery to help evaluate whether the margins are free of cancer cells. Participants will have their surgical specimens imaged with micro-PET-CT after tumor removal. Researchers will compare these imaging results to the final histological analysis to evaluate diagnostic performance. The main measure is how well the micro-PET-CT identifies malignant tumor margins compared to the gold standard. The study will monitor participants through surgery and imaging, with data collected until June 2026.
CONDITIONS
Brief Title
Performance of 18F-FDG Micro-PET-CT in the Assessment of Surgical Margins in Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- 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
You will not qualify if you...
- Child-Pugh C liver failure
- 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 m�b2)
- Patients unable to understand the study for any reason or to comply with the trial requirements (language, psychological, or geographical issues).
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo surgery for their head and neck cancer, followed by evaluation of the surgical specimen using micro-PET-CT.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Centre Henri Becquerel
Rouen, France
Actively Recruiting
Research Team
L
Lise-Marie Roussel, MD
D
Doriane Richard, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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