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

Lausanne University Hospital (CHUV)

Status and phase

Terminated

Phase 1

Conditions

Pathological Angiogenesis

Treatments

Radiation: 18F-FDG PET/CT

Radiation: 18F-FET PET/CT

Drug: 68Ga-NODAGA-RGD PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT02666547

220/12 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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