Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT01881620
Eligibility Criteria:
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:
1. 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.
2. Lung cancer
* Initial staging,
* Diagnosis of lung isolated lesion \> 1 cm.
3. Head and neck cancer
* Initial pretreatment staging,
* Recurrence diagnosis
4. 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.
5. Thyroid cancer: suspicion of residual disease or relapse when conventional imaging data are insufficient.
6. Ovarian cancer recurrence
7. Age ≥ 18 years.
8. Chest-abdomen-pelvis enhanced CT scan achieved within 4 weeks before enrollment (with cuts of less than 5 mm).
9. Woman of childbearing age with negative pregnancy test and / or contraception.
10. Patient with informed consent signed.
11. Patient affiliated to social security schemes.
Exclusion Criteria:
1. Iodine known allergy.
2. Diabetes, excepted if controlled (hemoglucotest ≤ 1.6 g).
3. Known renal failure (creatinine clearance \<60ml/min).
4. Indications against Xenetix ®:
* Hypersensitivity to Xenetix ® or any of the excipients,
* History of an immediate response or delayed cutaneous reaction to Xenetix ® injection.
* Thyrotoxicosis.
5. Pregnant or lactating women.
6. Unable to undergo medical follow up for geographical, social or psychological reasons,
7. Private of freedom patient and adult under a legal guardianship or unable to consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01881620
Study Brief:
Protocol Section:
NCT01881620