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| Name | Class |
|---|---|
| George Coukos, MD PhD, Head of oncology | UNKNOWN |
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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.
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-NODAGA-RGD,18F-FDG,18F-FET PET/CTs | Other | Active Comparator: 68Ga-NODAGA-RGD radiotracer All patients will undergo a 68Ga-NODAGA-RGD PET/CT, a 18F-FDG PET/CT or a 18F-FET PET/CT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-NODAGA-RGD PET/CT | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of each method of imaging for detection of tumors | 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 | within 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| ROC analysis and comparison of areas under the curve | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John O Prior, MD, PhD | Lausanne University Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois, Nuclear Medicine | Lausanne | Canton of Vaud | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32382869 | Result | Durante S, Dunet V, Gorostidi F, Mitsakis P, Schaefer N, Delage J, Prior JO. Head and neck tumors angiogenesis imaging with 68Ga-NODAGA-RGD in comparison to 18F-FDG PET/CT: a pilot study. EJNMMI Res. 2020 May 7;10(1):47. doi: 10.1186/s13550-020-00638-w. | |
| 36720731 | Derived | Dietz M, Dunet V, Mantziari S, Pomoni A, Dias Correia R, Testart Dardel N, Boughdad S, Nicod Lalonde M, Treglia G, Schafer M, Schaefer N, Prior JO. Comparison of integrin alphavbeta3 expression with 68Ga-NODAGA-RGD PET/CT and glucose metabolism with 18F-FDG PET/CT in esophageal or gastroesophageal junction cancers. Eur J Hybrid Imaging. 2023 Feb 1;7(1):3. doi: 10.1186/s41824-023-00162-9. |
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| ID | Term |
|---|---|
| D009389 | Neovascularization, Pathologic |
| ID | Term |
|---|---|
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 18F-FDG PET/CT | Radiation | 3.5 MBq/kg 18F-FDG will be administered i.v. and images acquired on all body |
|
| 18F-FET PET/CT | Radiation | 200 MBq 18F-FET will be administered i.v. and images acquired centred on the skull |
|
| Within 10 days |
| Comparison 68Ga-NODAGA-RGD to standard routine extension imaging assessments | 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) | within 10 days |