Clinical trial NCT02666547: 68Ga-NODAGA-RGD PET/ CT for Tumoral Neoangiogenesis
Official title: Value of PET/ CT in the 68Ga-NODAGA-RGD for the Evaluation of the Tumoral Neoangiogenesis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Pathological Angiogenesis
Keywords: 68Ga-NODAGA-RGD
18F-FDG
18F-FET
PET/CT
neoangiogenesis
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: George Coukos, MD PhD, Head of oncology
First posted: 2016-01-28
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of each method of imaging for detection of tumors
timeFrame: within 10 days
Secondary outcomes:
measure: ROC analysis and comparison of areas under the curve
timeFrame: Within 10 days
measure: Comparison 68Ga-NODAGA-RGD to standard routine extension imaging assessments
timeFrame: within 10 days
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois, Nuclear Medicine
state: Vaud
Study officials:
affiliation: Lausanne University Hospitals
name: John O Prior, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Durante S, Dunet V, Gorostidi F, Mitsakis P, Schaefer N, Delage J, Prior JO. Head and neck tumors angiogenesis imaging with 68Ga-NODAGA-RGD in comparison to 18F-FDG PET/CT: a pilot study. EJNMMI Res. 2020 May 7;10(1):47. doi: 10.1186/s13550-020-00638-w.