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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02666599
• Other study ID #: 363/11
• Status: Terminated
• Phase: N/A
• Start date: February 2014
• Est. completion date: March 30, 2024

Study information

• Verified date: June 2024
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 30, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

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 ß+ from the lesion (s) seen durint the PET/CT will be detected with the probe. Resected pieces will be analysed histologically.

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	Vaus

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensibility of the probe ß+ for detection per-surgery of hypermetabolic tumoral lesions	Topography and intensity of detection by the probe of emission of ß+ by the lesion(s); • Intensity of emission of ß+ by the non specific background and the adjacent structures	day 0
Secondary	PET/CT imaging results	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	day 0
Secondary	Sensibility of the probe ß+ for detection per-surgery of hypermetabolic tumoral lesions	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	within 10 days after study procedure
Secondary	.Comparison of AUC of the imaging methods	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	within 10 days after study procedure