Clinical Trial: 68Ga-NODAGA-RGD PET/ CT for Tumoral Neoangiogenesis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Value of PET/ CT in the 68Ga-NODAGA-RGD for the Evaluation of the Tumoral 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 Summary:
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
Sponsor: University of Lausanne Hospitals
Current Primary Outcome: Comparison of each method of imaging for detection of tumors [ Time Frame: within 10 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- ROC analysis and comparison of areas under the curve [ Time Frame: 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 [ Time Frame: 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)
Original Secondary Outcome: Same as current
Information By: University of Lausanne Hospitals
Dates:
Date Received: January 24, 2016
Date Started: December 2014
Date Completion: December 2018
Last Updated: November 13, 2016
Last Verified: November 2016