NCT02666547

68Ga-NODAGA-RGD PET/ CT for Tumoral Neoangiogenesis

Value of PET/ CT in the 68Ga-NODAGA-RGD for the Evaluation of the Tumoral Neoangiogenesis

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: University of Lausanne Hospitals · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pathological Angiogenesis

Interventions

Type	Name	Description
DRUG	68Ga-NODAGA-RGD PET/CT	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
RADIATION	18F-FDG PET/CT	3.5 MBq/kg 18F-FDG will be administered i.v. and images acquired on all body
RADIATION	18F-FET PET/CT	200 MBq 18F-FET will be administered i.v. and images acquired centred on the skull

Timeline

• Start date: 2014-03-01
• Primary completion: 2023-08-01
• Completion: 2023-09-01
• First posted: 2016-01-28
• Last updated: 2024-06-20

Locations

1 site across 1 country: Switzerland