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

L

Lausanne University Hospital (CHUV)

Status

Terminated

Conditions

Neoplasms

Treatments

Radiation: 18F-FDG PET/CT

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

5 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Exclusion criteria

  • Pregnancy
  • Enable to sign informed consent

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5 participants in 1 patient group

18F-FDG PET/CT
Experimental group
Description:
18F-FDG radiotracer All patients will undergo a 18F-FDG PET/CT and a surgery with probe detection of β+''
Treatment:
Radiation: 18F-FDG PET/CT

Trial contacts and locations

1

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Central trial contact

John O Prior, PhD MD; Christine Geldhof

Data sourced from clinicaltrials.gov

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