Neoplasms
Conditions
Keywords
F-18-FDG, neoplasm, probe, positron, diagnosis, surgery, radioguided surgery
Brief summary
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
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.
Interventions
RADIATION18F-FDG PET/CT
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.
Sponsors
University of Lausanne Hospitals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensibility of the probe β+ for detection per-surgery of hypermetabolic tumoral lesions | day 0 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PET/CT imaging results | day 0 | * 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 |
| Sensibility of the probe β+ for detection per-surgery of hypermetabolic tumoral lesions | within 10 days after study procedure | 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 |
| .Comparison of AUC of the imaging methods | within 10 days after study procedure | 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 |
Countries
Switzerland
Outcome results
None listed