Status:
COMPLETED
PET Enhanced CT Scan Performance in Cancer
Lead Sponsor:
Institut Bergonié
Conditions:
Cancer Disease Progression
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed 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 s...
Eligibility Criteria
Inclusion
- 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
- Preoperative evaluation in local and metastatic recurrence
- Location of recurrences, in case of ACE increase in a previously operated patient.
- Esophageal cancer: initial staging.
- Pancreatic cancer
- Initial staging,
- Differential diagnosis with chronic pancreatitis.
- 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
- Initial staging,
- Diagnosis of lung isolated lesion \> 1 cm.
- Head and neck cancer
- Initial pretreatment staging,
- Recurrence diagnosis
- Lymphoma
- Initial staging of Hodgkin's disease (HD), non-Hodgkin's lymphoma (NHL) and aggressive follicular lymphomas,
- Diagnosis of minimal residual disease of HD and aggressive NHL,
- Early assessment of treatment response.
- 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
- Iodine known allergy.
- Diabetes, excepted if controlled (hemoglucotest ≤ 1.6 g).
- Known renal failure (creatinine clearance \<60ml/min).
- Indications against Xenetix ®:
- Hypersensitivity to Xenetix ® or any of the excipients,
- History of an immediate response or delayed cutaneous reaction to Xenetix ® injection.
- Thyrotoxicosis.
- 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.
Key Trial Info
Start Date :
March 19 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2015
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT01881620
Start Date
March 19 2010
End Date
July 15 2015
Last Update
November 18 2024
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