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 ]

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


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