Patients with primary tumor likely diagnosis with 18F-FCH PET / CT or patients with local recurrence or distant shapes of the same histological MedDRA version: 9.1 Level: HLT Classification code 10029105 Term: Neoplasms malignant site unspecified NEC
Conditions
Sponsors
AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients of both sexes, and more children under 18, with histological diagnosis of primary tumor likely diagnosis with 18F-FCH PET / CT or patients with local or distant recurrence of the same histological forms, from which they may find a more precise indication to chemotherapy or radiation treatments; in the case of female patients of childbearing age, the examination is performed only in the absence of documented pregnancy. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Established pregnancy (if breastfeeding is discontinued for 24 hours)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Validate the Ch-18F PET / CT compared to MRI and neurosurgical target resulting from the histological biopsy material or surgically removed, both the lesion and the glial early relapse; validate the ability of 18F-Ch PET / CT to define, through the SUV, the grading of the disease, compared with the MRI-spectroscopy and histological findings; define the prognostic value of SUV in relation to survival;Secondary Objective: Relate the grading of the disease, defined by the SUV, with the neurosurgery (extension for end and radicalism in relation to the areas with the highest SUV) el`outcome patient (disease-free interval and survival time); evaluate the recurrence of disease after standard treatment, radiation therapy, with target conventionally designed solely with MRI images, and chemotherapy to determine if the resumption of the disease is in the area marked by high-grading SUV.;Primary end point(s): Validate the Ch-18F PET / CT compared to MRI and neurosurgical target resulting from the histological biopsy material or surgically removed, both the lesion and the glial early relapse; validate the ability of 18F-Ch PET / CT to define, through the SUV, the grading of the disease, compared with the MRI-spectroscopy and histological findings; define the prognostic value of SUV in relation to survival | — |
Countries
Italy
Outcome results
None listed