NCT01892501

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 4, 2013

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2019

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 27, 2021

Completed
Last Updated

September 3, 2025

Status Verified

April 1, 2021

Enrollment Period

6.8 years

First QC Date

June 26, 2013

Results QC Date

December 14, 2020

Last Update Submit

August 22, 2025

Conditions

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

Keywords

Mediastinal lymphadenopathyPET CT to 18FDGEUS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Negative Predictive Value

    12 months

  • Matching Between Therapeutic Strategies RCP1/RCP2

    12 months

  • Clinical Utility (Avoid More Invasive Procedure)

    12 months

Other Outcomes (1)

  • Side Effects - Number of Adverse Event Declared According to DINDO Classification

    12 months

Study Arms (1)

hypermetabolic mediastinal lymph nodes in PET,

OTHER

hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence.

Procedure: Guided punction of mediastinal lymphadenopathy by echoendoscopyDevice: PET scan

Interventions

Guided punction of mediastinal lymphadenopathy by echoendoscopyPROCEDURE

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.

hypermetabolic mediastinal lymph nodes in PET,
PET scanDEVICE

The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts

hypermetabolic mediastinal lymph nodes in PET,

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.
  • 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
  • Patient with indication of diagnostic procedure surgically (whether realized or not)
  • Lymph node(s) available(s) puncture by EUS esophageal, so for a technically feasible for esophageal puncture (without vascular recusants structures)
  • Age ≥ 18 years.
  • PET scan performed within 6 weeks before EUS
  • Platelets ≥ 70 000/mm3; TP ≥ 60%.
  • Patient of childbearing age with negative pregnancy test and / or a contraception.
  • Patient gave informed consent signed.
  • +1 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Insitut Bergonie

Bordeaux, Grionde, 33076, France

Location

Related Publications (1)

  • Bechade D, Bellera C, Gauquelin L, Soubeyran I, McKelvie-Sebileau P, Debled M, Chomy F, Roubaud G, Fonck M, Pernot S, Roch A, Cazeau AL. Diagnostic accuracy and clinical impact of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) in Positron Emission Tomography - Computed Tomography (PET-CT)-positive mediastinal lymphadenopathies in patients with thoracic or extra-thoracic malignancies. Clin Res Hepatol Gastroenterol. 2022 May;46(5):101912. doi: 10.1016/j.clinre.2022.101912. Epub 2022 Mar 25.

    PMID: 35341993BACKGROUND

MeSH Terms

Interventions

Positron-Emission Tomography

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Results Point of Contact

Title
Dr. Dominique Bechade, Coordinating Investigator
Organization
Institute Bergonie
d.bechade@bordeaux.unicancer.fr
0556337805

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2013

First Posted

July 4, 2013

Study Start

January 8, 2013

Primary Completion

October 10, 2019

Study Completion

October 10, 2019

Last Updated

September 3, 2025

Results First Posted

April 27, 2021

Record last verified: 2021-04

Locations

FR(1)