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

NCT02666599 | Terminated

• 1 other identifier: 363/11
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Neoplasms

Keywords

F-18-FDG; neoplasm; probe; positron; diagnosis; surgery; radioguided surgery

Outcome Measures

Primary Outcomes (1)

• Sensibility of the probe β+ for detection per-surgery of hypermetabolic tumoral lesions

  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

  day 0

Secondary Outcomes (3)

• PET/CT imaging results

  day 0

• Sensibility of the probe β+ for detection per-surgery of hypermetabolic tumoral lesions

  within 10 days after study procedure

• .Comparison of AUC of the imaging methods

  within 10 days after study procedure

Study Arms (1)

18F-FDG PET/CT

EXPERIMENTAL

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

Interventions

18F-FDG PET/CT 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.

18F-FDG PET/CT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Enable to sign informed consent

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Vaus, 1011, Switzerland

Location

MeSH Terms

Conditions

Neoplasms; Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John O Prior, PhD MD

  Lausanne University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Nuclear Medicine Department

Study Record Dates

• First Submitted: January 24, 2016
• First Posted: January 28, 2016
• Study Start: February 1, 2014
• Primary Completion: March 1, 2024
• Study Completion: March 30, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)