An interventional study of 18F-FDG PET/CT in Neoplasms, sponsored by University of Lausanne Hospitals. Terminated at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-06-20.
Sponsored by University of Lausanne Hospitals · Not applicable, Interventional, and Diagnostic
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
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.
9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's enrollment of 5 is below the median of 50 across 7,250 interventional studies indexed under Neoplasms.
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Exclusion Criteria:
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
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.
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
Time frame: day 0
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
Time frame: day 0
Sensibility of the probe β+ 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
Time frame: within 10 days after study procedure
.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
Time frame: within 10 days after study procedure
Plan to share: No
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University of Lausanne Hospitals