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

Sponsor

University of Lausanne Hospitals (Other)

Overall Status

Recruiting

CT.gov ID

NCT02666599

Collaborator

(none)

Enrollment

Location

Arm

106

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Neoplasms	Radiation: 18F-FDG PET/CT	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Feb 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 18F-FDG PET/CT 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 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.

Arm

Intervention/Treatment

Experimental: 18F-FDG PET/CT

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

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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