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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT02850302
Eligibility Criteria:
Inclusion Criteria:
* Women more than 18 years old
* breast cancer recently diagnosis (no prior treatment), histologically proven
* stade II or III in the "International union against cancer"(UICC) classification
* non metastatic patient
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* Negativity of estrogen and progesterone receptor of the tumor (\<10%)
* Absence of overexpression of HER2 according to the classification Immunohistochemistry (IHC) - score 0 or 1+
* Patient having read the information note
* written, dated and signed Informed consent
Exclusion Criteria:
* Unresectable breast cancer, bilateral, inflammatory (T4d) or metastatic.
* Unbalanced diabetes during PET scans (glucose more or equal to 9 mmol)
* Small breast cancer indication with first-conserving surgery
* Treated breast cancer history
* Pregnancy or breastfeeding
* Refusal of the patient for trial participation
* Private Person of liberty under supervision or under curators
* Inability to submit to medical follow-up testing for social or psychological reasons
* No affiliation to a social security scheme or medical state aid or the universal medical coverage
* Known allergy or hypersensitivity to 18F-fluorodeoxyglucose
* Patients with known renal impairment (creatinine clearance \<60 ml / min / 1.73m2) or a known hepatic failure
* Patients with a strict regime without salt (sodium levels may be higher than 1 mmol in a dose of 18 FDG).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT02850302
Study Brief:
Protocol Section:
NCT02850302