TableĀ 1.
Inclusion: V0 | Routine follow-up: V1-Vn | Visit with MRI: MRI1-MRI6 | Last visit | |
---|---|---|---|---|
Informed consent | X | |||
Verification of inclusion and non-inclusion criteria | X | |||
Medical history | X | |||
Clinical examination | X | X | X | X |
Biopsy | x | X | ||
MRI | X | |||
Sending MR examination (after 1st analysis) | X | |||
Sending biopsies examinations | x | X | ||
Collection of data in the electronic case report form: clinic, echography and histology (secondary objective 1) | X | X | X | |
Retrieval of adverse events (secondary objective 2) | X | X | X | |
Retrieval of serious adverse events | X | X | X | |
Questionnaire on patient satisfaction | X |
X means always; x means sometimes according to the biopsy calendar.