Pathological Angiogenesis Clinical Trial
Official title:
Value of PET/ CT in the 68Ga-NODAGA-RGD for the Evaluation of the Tumoral Neoangiogenesis
| NCT number | NCT02666547 |
| Other study ID # | 220/12 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 1 |
| First received | |
| Last updated | |
| Start date | March 2014 |
| Est. completion date | September 2023 |
| Verified date | June 2024 |
| Source | University of Lausanne Hospitals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 42 |
| Est. completion date | September 2023 |
| Est. primary completion date | August 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Age = 85 years old - Karnofsky index: = 80% - Patients presenting a neoplasic pathology, histologically proven, known to have expressed integrin avß3and 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 |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Centre Hospitalier Universitaire Vaudois, Nuclear Medicine | Lausanne | Vaud |
| Lead Sponsor | Collaborator |
|---|---|
| University of Lausanne Hospitals | George Coukos, MD PhD, Head of oncology |
Switzerland,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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. | Within 10 days | |
| Secondary | 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 |