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Hypothesis:
The investigators would like to demonstrate that diagnosis performance of PET/CT scan without and with contrast agent (COMBI TEP), are equivalent or better than those of PET/ non enhanced CT scan (PET scan) associated with an enhanced CT scan. This research project is a pilot study given the few available data concerning this imaging exam reproducibility.
This study is a prospective single center study.
Full description
Hypothesis:
We would like to demonstrate that diagnosis performance of PET/CT scan without and with contrast agent (COMBI TEP), are equivalent or better than those of PET/ non enhanced CT scan (PET scan) associated with an enhanced CT scan. This research project is a pilot study given the few available data concerning this imaging exam reproducibility. This study allows us to assess the feasibility of such a large-scale study, but also to evaluate COMBI TEP performance. From these estimates, we can then consider a comparative study to evaluate the performance of COMBI PET.
This study is a prospective single center study.
Enrollment
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Inclusion criteria
Any patient with a cancerous disease for which PET scan is indicated in the SOR (Standards - Options - Recommendations) FDG PET 2003 updated in 2006 must be included in the trial, in the following locations:
Digestive cancers
Colorectal cancer
Esophageal cancer: initial staging.
Pancreatic cancer
Liver cancer: differential diagnosis of liver metastases, cholangiocarcinoma and benign tumors in the case of an isolated hepatic localization.
Digestive Endocrine tumors: staging in case of normal pentetreotide scintigraphy.
Lung cancer
Head and neck cancer
Lymphoma
Thyroid cancer: suspicion of residual disease or relapse when conventional imaging data are insufficient.
Ovarian cancer recurrence
Age ≥ 18 years.
Chest-abdomen-pelvis enhanced CT scan achieved within 4 weeks before enrollment (with cuts of less than 5 mm).
Woman of childbearing age with negative pregnancy test and / or contraception.
Patient with informed consent signed.
Patient affiliated to social security schemes.
Exclusion criteria
Iodine known allergy.
Diabetes, excepted if controlled (hemoglucotest ≤ 1.6 g).
Known renal failure (creatinine clearance <60ml/min).
Indications against Xenetix ®:
Pregnant or lactating women.
Unable to undergo medical follow up for geographical, social or psychological reasons,
Private of freedom patient and adult under a legal guardianship or unable to consent.
Primary purpose
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Interventional model
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109 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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