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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2024-03-30

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

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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.

Conditions

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Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-FDG PET/CT

18F-FDG radiotracer All patients will undergo a 18F-FDG PET/CT and a surgery with probe detection of β+''

Group Type EXPERIMENTAL

18F-FDG PET/CT

Intervention Type RADIATION

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.

Interventions

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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.

Intervention Type RADIATION

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