Hypermetabolic Lymphadenopathy Mediastinum Lower, Posterior and Middle, Detected by PET-CT With 18F-FDG (PET)
Conditions
Keywords
Mediastinal lymphadenopathy, PET CT to 18FDG, EUS
Brief 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
Detailed 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.
Interventions
PROCEDUREGuided punction of mediastinal lymphadenopathy by echoendoscopy
EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion. Pathological samples are taken : 3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken.
DEVICEPET scan
The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts
Sponsors
Institut Bergonié
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of Endoscopic Ultrasound-guided (EUS-guided) Puncture | 12 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Negative Predictive Value | 12 months | 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) |
| Matching Between Therapeutic Strategies RCP1/RCP2 | 12 months | 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 |
| Clinical Utility (Avoid More Invasive Procedure) | 12 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Side Effects - Number of Adverse Event Declared According to DINDO Classification | 12 months | 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) |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hypermetabolic Mediastinal Lymph Nodes in PET, Hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence.
Guided punction of mediastinal lymphadenopathy by echoendoscopy: EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion.
Pathological samples are taken :
3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken.
PET scan: The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts | 75 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Non-contributory histological result | 12 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Puncture not carried out | 9 |
| Overall Study | Radiological monitoring not carried out | 5 |
Baseline characteristics
| Characteristic | Hypermetabolic Mediastinal Lymph Nodes in PET, | — |
|---|---|---|
| Age, Continuous | 63.01 years STANDARD_DEVIATION 13.64 | — |
| Height | 166.97 cm STANDARD_DEVIATION 8.67 | — |
| M status (Classification of Malignant Tumors) Could not be evaluated for distant metastases | 13 Participants | — |
| M status (Classification of Malignant Tumors) M0 | 17 Participants | — |
| M status (Classification of Malignant Tumors) M1 | 2 Participants | — |
| M status (Classification of Malignant Tumors) Missing | 5 Participants | — |
| N status (Classification of Malignant Tumors) Missing | 6 Participants | — |
| N status (Classification of Malignant Tumors) N+ | 17 Participants | — |
| N status (Classification of Malignant Tumors) N0 | 11 Participants | — |
| N status (Classification of Malignant Tumors) NX | 3 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 40 Participants | — |
| Sex: Female, Male Male | 35 Participants | — |
| Therapeutic strategy (absence of documentation) Chemotherapy or other carcinological treatment | 54 Participants | — |
| Therapeutic strategy (absence of documentation) Non-carcinological management in case of documented benign pathology | 12 Participants | — |
| Therapeutic strategy (absence of documentation) Not available | 1 Participants | — |
| Therapeutic strategy (absence of documentation) No treatment | 4 Participants | — |
| Therapeutic strategy (absence of documentation) Surgery right from the start | 4 Participants | — |
| Therapeutic strategy after documentation Chemotherapy or other carcinological treatment | 20 Participants | — |
| Therapeutic strategy after documentation Missing | 8 Participants | — |
| Therapeutic strategy after documentation No treatment | 13 Participants | — |
| Total number of lymph nodes per patient | 3.00 lymph nodes | — |
| T status (Classification of Malignant Tumors) T0 | 1 Participants | — |
| T status (Classification of Malignant Tumors) T1 | 7 Participants | — |
| T status (Classification of Malignant Tumors) T2 | 9 Participants | — |
| T status (Classification of Malignant Tumors) T3 | 13 Participants | — |
| T status (Classification of Malignant Tumors) T4 | 5 Participants | — |
| T status (Classification of Malignant Tumors) TX | 2 Participants | — |
| Weight | 72.53 kg STANDARD_DEVIATION 16.46 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 47 |
| other Total, other adverse events | 34 / 47 |
| serious Total, serious adverse events | 34 / 47 |
Outcome results
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).
Time frame: 12 months
Population: Patient eligible and evaluable for primary endpoint (N=47) (excluded patients with non-contributory histological results, puncture not carried out, radiological monitoring not carried out)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hypermetabolic Mediastinal Lymph Nodes in PET, | Sensitivity of Endoscopic Ultrasound-guided (EUS-guided) Puncture | 93 percentage |
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.
Time frame: 12 months
Population: Patients evaluable for clinical utility
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hypermetabolic Mediastinal Lymph Nodes in PET, | Clinical Utility (Avoid More Invasive Procedure) | 95.7 percentage of patients |
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
Time frame: 12 months
Population: Patients eligible and evaluable with available pre (before endoscopy results) AND post documentation (after endoscopy results) therapeutic strategies.~Of note, 6 patients without therapeutic strategies after endoscopy results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hypermetabolic Mediastinal Lymph Nodes in PET, | Matching Between Therapeutic Strategies RCP1/RCP2 | 44.7 percentage of patients |
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)
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hypermetabolic Mediastinal Lymph Nodes in PET, | Negative Predictive Value | 90 percentage |
Other Pre-specified
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)
Time frame: 12 months
Population: Patients with at least one adverse event with Dindo classification (N=38)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hypermetabolic Mediastinal Lymph Nodes in PET, | Side Effects - Number of Adverse Event Declared According to DINDO Classification | Not available | 54 Number of adverse event per grade |
| Hypermetabolic Mediastinal Lymph Nodes in PET, | Side Effects - Number of Adverse Event Declared According to DINDO Classification | I | 6 Number of adverse event per grade |
| Hypermetabolic Mediastinal Lymph Nodes in PET, | Side Effects - Number of Adverse Event Declared According to DINDO Classification | II | 2 Number of adverse event per grade |
| Hypermetabolic Mediastinal Lymph Nodes in PET, | Side Effects - Number of Adverse Event Declared According to DINDO Classification | IIIb | 6 Number of adverse event per grade |