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Clinical Trial Summary

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


Clinical Trial Description

Main objective : Assess the performance (in terms of sensitivity) of guided punction by echoendoscopy in the characterization of hypermetabolic mediastinal lymph nodes in PET, in a context of New cancer or cancer recurrence. Conduct of the study : When a patient has had a PET scan showing a hypermetabolic or mediastinal lymph nodes in the lower, middle or posterior, his case is presented in a multidisciplinary meeting (PCR # 1), with definition of diagnostic strategy: Approved indication is achieve a biopsy surgically to have a histological documentation of mediastinal lymph nodes with obvious impact on treatment decisions. We distinguish two groups of patients based on the feasibility of the surgical procedure: 1. Group A biopsy is surgically feasible 2. Group B: biopsy by surgery can not be performed (against medical contraindications or anesthetics) at that moment, definition of therapeutic strategy that was decided in the absence of histological documentation: - Surgery outset - Chemotherapy or other oncological treatment - Supports non-oncological if benign disease suspected - No treatment. EUS is performed by oesophageal for two patient groups for the two groups of patients (within a maximum period of six weeks after the PET scan), under general anesthesia and endoscopic control. According the pathological findings, the therapeutic strategy is defined in a second PCR (PCR # 2), to assess the impact of the puncture: - Surgery outset - Chemotherapy or other oncological treatment - Supports non-oncological when benign pathology documented - No treatment - Selecting another surgical diagnostic procedure (non-contributory income). A patient monitoring will be conducted for 12 months. The clinical and radiological data carried over the standard of care of the patient will be collected. Achieving a thoracoabdominopelvic scanner (TAP) at 1 year to characterize the evolution of the disease marks the end of the study for the patient. For the patients who have had a negative biopsy, monitoring will involve a scanner TAP 6 month and 12 month then consultation with the oncologist. ;


Study Design


Related Conditions & MeSH terms

  • Hypermetabolic Lymphadenopathy Mediastinum Lower, Posterior and Middle, Detected by PET-CT With 18F-FDG (PET)
  • Lymphadenopathy

NCT number NCT01892501
Study type Interventional
Source Institut Bergonié
Contact
Status Completed
Phase N/A
Start date January 8, 2013
Completion date October 10, 2019