Per-operating Use of a Probe for Detection of β+
- Conditions
- Neoplasms
- Interventions
- Radiation: 18F-FDG PET/CT
- Registration Number
- NCT02666599
- Lead Sponsor
- University of Lausanne Hospitals
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- 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
- Pregnancy
- Enable to sign informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 18F-FDG PET/CT 18F-FDG PET/CT 18F-FDG radiotracer All patients will undergo a 18F-FDG PET/CT and a surgery with probe detection of β+''
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.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
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
Trial Locations
- Locations (1)
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Vaus, Switzerland