Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
42 participants
INTERVENTIONAL
2014-03-31
2023-09-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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68Ga-NODAGA-RGD,18F-FDG,18F-FET PET/CTs
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 PET/CT
200 MBq 68 Ga-NODAGA-RGD will be administered i.v. and images acquired on all body . For glioma, images acquired centred on the skull
18F-FDG PET/CT
3.5 MBq/kg 18F-FDG will be administered i.v. and images acquired on all body
18F-FET PET/CT
200 MBq 18F-FET will be administered i.v. and images acquired centred on the skull
Interventions
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68Ga-NODAGA-RGD PET/CT
200 MBq 68 Ga-NODAGA-RGD will be administered i.v. and images acquired on all body . For glioma, images acquired centred on the skull
18F-FDG PET/CT
3.5 MBq/kg 18F-FDG will be administered i.v. and images acquired on all body
18F-FET PET/CT
200 MBq 18F-FET will be administered i.v. and images acquired centred on the skull
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy, breastfeeding
* Age \<18 years
18 Years
ALL
No
Sponsors
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George Coukos, MD PhD, Head of oncology
UNKNOWN
University of Lausanne Hospitals
OTHER
Responsible Party
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John O. Prior
Chief Nuclear Medicine Department
Principal Investigators
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John O Prior, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Lausanne University Hospitals
Locations
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Centre Hospitalier Universitaire Vaudois, Nuclear Medicine
Lausanne, Canton of Vaud, Switzerland
Countries
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References
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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.
Dietz M, Dunet V, Mantziari S, Pomoni A, Dias Correia R, Testart Dardel N, Boughdad S, Nicod Lalonde M, Treglia G, Schafer M, Schaefer N, Prior JO. Comparison of integrin alphavbeta3 expression with 68Ga-NODAGA-RGD PET/CT and glucose metabolism with 18F-FDG PET/CT in esophageal or gastroesophageal junction cancers. Eur J Hybrid Imaging. 2023 Feb 1;7(1):3. doi: 10.1186/s41824-023-00162-9.
Other Identifiers
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220/12
Identifier Type: -
Identifier Source: org_study_id
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