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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A01888-45 | Other Identifier | ANSM |
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Interventional, exploratory, prospective and monocentric study which aim to study the feasibility of brachytherapy using a PET-scan
The study will proceed as follow:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Procedure | Experimental | Brachytherapy. PET-scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brachytherapy | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 months |
| Assessment of the HR-CTV coverage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abel CORDOBA, MD | Centre oscar Lambret de Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Lille | 59020 | France |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
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| PET-scan | Other | The patient will undergo 2 PET-scan during the clinical trial:
|
|
Comparison of the HR-CTV obtained with TEP-curie to the HR-CTV obtained by the RMI alone
| 4 months |
| Assessment of the dose received by the neighboring target organs | Comparison of the dose obtained with TEP-curie to the dose obtained by the RMI alone | 4 months |
| Time needed to design the different alternative treatment plans | 4 months |
| Toxicity linked to the standard treatment driven by RMI only | Graded according to the NCI CTCAE v4. scale | 4 months |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D008919 |
| Investigative Techniques |