Hypermetabolic Lymphadenopathy Mediastinum Lower, Posterior and Middle, Detected by PET-CT With 18F-FDG (PET) Clinical Trial
— APOGEEOfficial title:
Feasibility Study on the Contribution of Guided Puncture With Echoendoscopy in Evaluation of Hypermetabolic Lymphadenopathy Mediastinum Lower, Rear and Middle, Detected in PET-CT to 18 FDG (PET)
| Verified date | April 2021 |
| Source | Institut Bergonié |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Impact of screening nodes mediastinal by PET, at different times of the management of cancer disease, remain unclear. Benefits of combined PET and puncture with echoendoscopy for the diagnosis subsequent therapeutic management should be evaluated in these different contexts. We would like to demonstrate the clinical utility of this association to replace more invasive diagnostic procedures and to assess the impact of the puncture on a possible modification of the therapeutic management. It is a single center prospective diagnostic assessment
| Status | Completed |
| Enrollment | 75 |
| Est. completion date | October 10, 2019 |
| Est. primary completion date | October 10, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Any patients who have had PET showing one or more hypermetabolic lymphadenopathy in middle mediastinum and/or lower and/or posterior, and requiring diagnostic certainty for support. 2. PET scans performed in these particulars : - Pre-treatment assessment of thoracic or extra-thoracic malignancies (patients without a history of cancer). - Evaluation of response to treatment referred to oncological. - Suspicion of relapse in patients with a personal history of thoracic or extra-thoracic malignancies. 3. PET, the result is positive : - For above-centimeter lymph node short axis: greater result than or equal to the background hepatic noise. - For sub-centimeter lymph node small axis : greater result than the background hepatic noise 4. Patient with indication of diagnostic procedure surgically (whether realized or not) 5. Lymph node(s) available(s) puncture by EUS esophageal, so for a technically feasible for esophageal puncture (without vascular recusants structures) 6. Age = 18 years. 7. PET scan performed within 6 weeks before EUS 8. Platelets = 70 000/mm3; TP = 60%. 9. Patient of childbearing age with negative pregnancy test and / or a contraception. 10. Patient gave informed consent signed. 11. Patient affiliated to a social security scheme. Exclusion Criteria: - Contra-indication (s) Director (s) to achieve a EUS. - Balance adverse anesthetic (not allowing a general anesthetic). - Esophageal stenosis. - Coagulation disorders. - Pregnant or lactating women. - Unable to undergo medical monitoring test for geographical, social or psychological reasons. - Private patient freedom and major subject of a measure of legal protection or unable to consent. |
| Country | Name | City | State |
|---|---|---|---|
| France | Insitut Bergonie | Bordeaux | Grionde |
| Lead Sponsor | Collaborator |
|---|---|
| Institut Bergonié |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Side Effects - Number of Adverse Event Declared According to DINDO Classification | In all cases the side effects associated with the implementation of the guided puncture EUS has been collected and classified according to the classification of surgical complications of Clavien-Dindo [P Clavien and al. Ann Surg 2009, 250: 187-96].
Classification of surgical complications of Clavien-Dindo ranges from grade 1 (any deviation from the normal postoperative course) to grade 5 (death of patient) |
12 months | |
| Primary | Sensitivity of Endoscopic Ultrasound-guided (EUS-guided) Puncture | The performance of EUS-guided biopsy has been evaluated in terms of sensitivity. EUS-guided was performed after detection of lymph nodes with positron emission tomography (PET). In most cases, only one lymph node is taken and performance analysis will be done by patient and not by injury.
PET, the reference technique (gold standard), is followed for 12 months. Sensitivity is the rate of subjects with a diagnosis of malignancy (excluding the results atypical / suspicious or non-contributory) according the results of EUS among all subjects with a neoplastic disease by the gold reference. To sum up , the sensitivity corresponds to the rate of patients detected as "malignant" with the new technique (EUS-guided), among the patients detected as "malignant" at the reference PET examination (12 months assessment). |
12 months | |
| Secondary | Negative Predictive Value | The negative predictive value of EUS-guided biopsy has been evaluated by the rate of subjects with a diagnosis of benign pathology according the gold standard (PET) among all subjects for wich EUS reveal a benign pathology (excluding atypical/suspects findings or non contributory) | 12 months | |
| Secondary | Matching Between Therapeutic Strategies RCP1/RCP2 | Impact of the management of patient :
Concordance between therapeutic strategies before the results of the endoscopy (Multidisciplinary consultation meeting 1 (RCP1) in absence of documentation) and after the results of endoscopy (Multidisciplinary consultation meeting 2 (RCP2) post-documentation) for the eligible and evaluable population |
12 months | |
| Secondary | Clinical Utility (Avoid More Invasive Procedure) | The clinical utility of puncture under echo-endoscopy puncture has been considered to have a clinical utility, if it allows the patient to avoid more invasive diagnostic procedures (mediastinoscopy or thoracoscopy) or if it allows the patient to benefit from appropriate treatment (result of the malignant biopsy) or to avoid receiving unjustified treatment (result of the benign biopsy): case of patients well classified as malignant/benign by puncture under echo-endoscopy.
The puncture will be considered to have no clinical utility if the result of the puncture under echo-endoscopy is invalidated by the reference examination, or if the result of the puncture does not allow a diagnosis to be made. |
12 months |