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

Phase 1

Terminated

• Conditions: Pathological Angiogenesis
• Interventions: Drug: 68Ga-NODAGA-RGD PET/CT; Radiation: 18F-FDG PET/CT; Radiation: 18F-FET PET/CT

• Registration Number: NCT02666547
• Lead Sponsor: University of Lausanne Hospitals

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 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

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2016-01-24
• Study First Submitted QC: 2016-01-24
• Study First Posted: 2016-01-28
• Primary Completion: 2023-08
• Study Completion: 2023-09
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Age ≤ 85 years old
• Karnofsky index: ≥ 80%
• Patients presenting a neoplasic pathology, histologically proven, known to have expressed integrin αvβ3and 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-NODAGA-RGD,18F-FDG,18F-FET PET/CTs	18F-FDG PET/CT	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
68Ga-NODAGA-RGD,18F-FDG,18F-FET PET/CTs	18F-FET PET/CT	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
68Ga-NODAGA-RGD,18F-FDG,18F-FET PET/CTs	68Ga-NODAGA-RGD PET/CT	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

Primary Outcome Measures

Name	Time	Method
Comparison of each method of imaging for detection of tumors	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

Secondary Outcome Measures

Name	Time	Method
ROC analysis and comparison of areas under the curve	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	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)

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois, Nuclear Medicine; 🇨🇭 Lausanne, Vaud, Switzerland