Clinical Trials Directory

Trials / Terminated

TerminatedNCT02666599

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
5 (actual)
Sponsor
University of Lausanne Hospitals · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
RADIATION18F-FDG PET/CTA 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.

Timeline

Start date
2014-02-01
Primary completion
2024-03-01
Completion
2024-03-30
First posted
2016-01-28
Last updated
2024-06-20

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT02666599. Inclusion in this directory is not an endorsement.