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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 July 2023 |
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Main ID: |
NCT02666547 |
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Date of registration:
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24/01/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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68Ga-NODAGA-RGD PET/ CT for Tumoral Neoangiogenesis
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Scientific title:
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Value of PET/ CT in the 68Ga-NODAGA-RGD for the Evaluation of the Tumoral Neoangiogenesis |
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Date of first enrolment:
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March 2014 |
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Target sample size:
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120 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02666547 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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John O Prior, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lausanne University Hospitals |
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Name:
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John O Prior, MD, PhD |
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Address:
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Telephone:
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+41 21 314 43 48 |
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Email:
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john.prior@chuv.ch |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age = 85 years old
- Karnofsky index: = 80%
- Patients presenting a neoplasic pathology, histologically proven, known to have
expressed integrin avß3and 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pathological Angiogenesis
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Intervention(s)
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Drug: 68Ga-NODAGA-RGD PET/CT
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Radiation: 18F-FET PET/CT
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Radiation: 18F-FDG PET/CT
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Primary Outcome(s)
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Comparison of each method of imaging for detection of tumors
[Time Frame: within 10 days]
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Secondary Outcome(s)
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ROC analysis and comparison of areas under the curve
[Time Frame: Within 10 days]
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Comparison 68Ga-NODAGA-RGD to standard routine extension imaging assessments
[Time Frame: within 10 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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