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

  • STATUS
    Recruiting
  • End date
    Dec 5, 2022
  • participants needed
    120
  • sponsor
    University of Lausanne Hospitals
Updated on 5 July 2022

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.

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

Details
Condition Pathological Angiogenesis
Treatment 68Ga-NODAGA-RGD PET/CT, 18F-FDG PET/CT, 18F-FET PET/CT
Clinical Study IdentifierNCT02666547
SponsorUniversity of Lausanne Hospitals
Last Modified on5 July 2022

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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