Per-operating Use of a Probe for Detection of β+

Study Overview
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Brief Summary
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The objective of the study is to evaluate the sensibility of the probe Forimtech to detect β+ emission in vivo in humans and its usefulness during elective surgical procedure Hypothesis:The probe Forimtech is able to allow per-surgery detection of tumoral lesions sensible to 18F-FDG and to help in the realization of guided biopsies, minimally invasive surgery or complement of resection of tumors. The β+ emission detected by the probe Forimtech is correlated to the emission γ detected by the 18F-FDG.PET/CT

Detailed Description
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Patients with a malignant neoplasic lesion known or suspected for which a surgery is planned will be presented with the protocol. If inclusion/exclusion criteria are fulfilled all the procedures will be planned. A 18F-FDG PET/CT will be done. Surgery will be conducted within 3 hours after the I.V. injection of 18F-FDG according to the standard procedure applied in the visceral surgery department. During the surgery, emission of β+ from the lesion (s) seen during the PET/CT will be detected with the probe. Resected pieces will be analysed histologically.

Official Title
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Per-operating Use of a Probe for Detection of β+

Conditions
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Neoplasms

Intervention / Treatment
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* Radiation: 18F-FDG PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age < 80 years old; Karnofsky index ≥80% ; Informed consent signed Patients with an indication of thoracic, visceral, or ENT surgery with the aim of a diagnostic biopsy, of an invasive minimal treatment, or an initial or complementary resection Exclusion Criteria: Pregnancy Enable to sign informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-FDG PET/CT<br>18F-FDG radiotracer All patients will undergo a 18F-FDG PET/CT and a surgery with probe detection of β+'' | Radiation: 18F-FDG PET/CT<br>* A 18F-FDG PET/CT will be done. A dose of 19 µSv/MBq will be received by the patient. Surgery will be conducted within 3 hours after the I.V. injection of 18F-FDG according to the standard procedure applied in the visceral surgery department. During the surgery, emission of β+ from the lesion (s) seen durint the PET/CT will be detected with the probe. Resected pieces will be analysed histologically.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensibility of the probe β+ for detection per-surgery of hypermetabolic tumoral lesions | Topography and intensity of detection by the probe of emission of β+ by the lesion(s) • Intensity of emission of β+ by the non specific background and the adjacent structures | day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET/CT imaging results | 18F-FDG PET imaging: SUVmax of the lesion(s), SUVmean of the lesion(s), ratio SUVmax / SUVbackground CT imaging: Topography of / the lesion(s), size of / the lesion(s), distance with the surrounding organs | day 0 | 
| Sensibility of the probe β+ for detection per-surgery of hypermetabolic tumoral lesions | Change in every primary interpretation criterion corresponding to the parameters of detection found during the operation will be studied and compared with the analysis of the parameters of the histology (gold standard) through an analysis ROC. They will be also studied compared with the analysis of the parameters PET/ CT | within 10 days after study procedure | 
| .Comparison of AUC of the imaging methods | A comparison of the AUC will be realized to determine the superiority of a method compared with the other one, by a non parametric test comparing AUC, ROC curves respectively | within 10 days after study procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radioguided surgery, F-18-FDG, neoplasm, probe, positron, diagnosis, surgery