Interventional, exploratory, prospective and monocentric study which aim to study the feasibility of brachytherapy using a PET-scan
The study will proceed as follow: * Initial check-up before the brachytherapy, including a clinical exam, collect of disease history and other informations that can be required for a good execution of the trial, and a usual patient care (chemotherapy with concomitant radiotherapy, biopsy, RMI, PET-scan and paraaortic lymphadenectomy). * additional PET-scan exam at day 1 of the brachytherapy (with collect of informations on toxicity, clinical morphology data and biomorphological data of RMI and PET-scan, and dosimetric study of the brachytherapy) * 4 months after the brachytherapy, additional PET-scan monitoring metabolic volumes and standardized metabolic fixation parameters
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
14
Before it starts, a consultation will be done to collect patient's informations and disease history, a clinical exam will be done and an evaluation of radio-chemotherapy toxicity will be realized. The brachytherapy include a pulsating flow treatment driven by RMI and CT-scan
The patient will undergo 2 PET-scan during the clinical trial: * the first one is additional to the brachytherapy * the second one is realized 4 months after the brachytherapy
Centre Oscar Lambret
Lille, France
Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) in terms of realized exams
Concerning this outcome, the success in terms of feasibility will be the possibility of realizing the TEP-Curie exam
Time frame: 4 months
Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the possibility to define HR-CTV target volume (High-Risk Clinical Target Volume)
Concerning this outcome, the success in terms of feasibility will be the possibility of defining a HR-CTV target volume for at least one of the 3 proposed approaches using the PET
Time frame: 4 months
Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the dicom medical image transfer
Concerning this outcome, the success in terms of feasibility will be the possibility of transfering image in a Dicom format
Time frame: 4 months
Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the contouring possibility
Using the possibility of defining the contouring for at least one of the 3 alternative treatment plans
Time frame: 4 months
Impact of the "TEP-Curie" (Brachytherapy driven by PET-scan) on target volume definition
Comparison of the target volume obtained with TEP-curie to the target volume defined by the RMI alone
Time frame: 4 months
Assessment of the HR-CTV coverage
Comparison of the HR-CTV obtained with TEP-curie to the HR-CTV obtained by the RMI alone
Time frame: 4 months
Assessment of the dose received by the neighboring target organs
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Comparison of the dose obtained with TEP-curie to the dose obtained by the RMI alone
Time frame: 4 months
Time needed to design the different alternative treatment plans
Time frame: 4 months
Toxicity linked to the standard treatment driven by RMI only
Graded according to the NCI CTCAE v4. scale
Time frame: 4 months