Pathological Angiogenesis
Conditions
Keywords
68Ga-NODAGA-RGD, 18F-FDG, 18F-FET, PET/CT, neoangiogenesis
Brief summary
This study will assess the potential of the 68Ga-NODAGA-RGD for the evaluation of neoangiogenesis in patients followed for a neoplastic pathology and for whom a18F-FDG (or 18F-FET for gliomas) is indicated for initial extension evaluation or suspicion of recurrent tumor.
Detailed description
The purpose of this study is to assess the value of 68Ga-NODAGA-RGD PET/CT for detection of neoangiogenesis at level of neoplastic processes, in patients, compared to 18F-FDG PET/CT (tumors other than glioma) or 18F-FET PET/CT (patients affected by glioma) and to determine the respective diagnostic contribution of every technique. Every patient will undergo a routine 18F-FDG (or 18F-FET) PET/CT followed by a 68Ga-NODAGA-RGD PET / CT specific for the study within the next 7 days. (each image procedure duration: 2h) The criteria of primary evaluation for each of the techniques will be defined: * On the images of PET/CT: SUVmax, SUVmoyen, VOI ( mL ), SUV41 % ratio \[mean SUV of pixels ≥ 41 % of the SUVmax\] of lesions / SUV * On the images of CT: size of the lesions measured in 3D (axial, coronal and sagittal), density in Hounsfield unit (HU) The 18F-FDG/18F-FET and 68Ga-NODAGA-RGD PET / CTs will be analyzed at first separately then will be compared according to the methods described in the analysis
Interventions
200 MBq 68 Ga-NODAGA-RGD will be administered i.v. and images acquired on all body . For glioma, images acquired centred on the skull
RADIATION18F-FDG PET/CT
3.5 MBq/kg 18F-FDG will be administered i.v. and images acquired on all body
RADIATION18F-FET PET/CT
200 MBq 18F-FET will be administered i.v. and images acquired centred on the skull
Sponsors
George Coukos, MD PhD, Head of oncology
University of Lausanne Hospitals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≤ 85 years old * Karnofsky index: ≥ 80% * Patients presenting a neoplasic pathology, histologically proven, known to have expressed integrin αvβ3and for which a 18F-FDG (or a 18F-FETfor glioma) is indicated : (1) glioma (WHO I, II-IV), (2) malignant melanoma, (3) cancer of upper respiratory tract, (4) breast cancer,(5) bone metastasis, (6) ovarian cancer, (7) lung cancer,(8) non-Hodgkinian malignant lymphoma with extra- lymphatic nodes extension, (9) neuroendocrine tumors, (10) pancreatic cancer,(11) oesophagus cancer,(12) stomach cancer. 10 patients will be included per type of cancer. * Informed consent signed
Exclusion criteria
* Incapacity to sign the informed consent * Pregnancy, breastfeeding * Age \<18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of each method of imaging for detection of tumors | within 10 days | To compare the capacity of each of the techniques and their combination to detect tumors, to determine the composition of these tumors (neoangiogenesis, metabolism, necrosis), their extension, the changes due to treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ROC analysis and comparison of areas under the curve | Within 10 days | A ROC analysis will be realized as well as a comparison of AUCs, to determine the superiority of a method compared to the other one, using a parametric test comparing of the AUC curves and ROC curves respectively by an established algorithm. The criteria of interpretation and positivity will be defined in a standard way on the images 18F-FDG / 18F-FET and 68Ga-NODAGA-RGD. |
| Comparison 68Ga-NODAGA-RGD to standard routine extension imaging assessments | within 10 days | The sensibility for detection of tumor by the 68Ga-NODAGA-RGD will be assessed and compared with the standard routine extension assessements including 18F-FDG PET/CT or18F-FET PET/CT, CT or any other complementary exam (US, MRI) |
Countries
Switzerland
Outcome results
None listed