Hypermetabolic Lymphadenopathy Mediastinum Lower, Posterior and Middle, Detected by PET-CT With 18F-FDG (PET)APOGEENCT01892501
Feasibility Study on the Contribution of Guided Puncture With Echoendoscopy
A study testing Guided punction of mediastinal lymphadenopathy by echoendoscopy and PET scan in people with Hypermetabolic Lymphadenopathy Mediastinum Lower, Posterior and Middle, Detected by PET-CT With 18F-FDG (PET), run by Institut Bergonié at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypermetabolic Lymphadenopathy Mediastinum Lower, Posterior and Middle, Detected by PET-CT With 18F-FDG (PET)
- What is being tested?
- Guided punction of mediastinal lymphadenopathy by echoendoscopy and PET scan
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2013to 10 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 :
Show all 16Show fewer
- 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.
- Patient affiliated to a social security scheme.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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
Read the 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:
- Group A biopsy is surgically feasible
- 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.
- Being tested
- Guided punction of mediastinal lymphadenopathy by echoendoscopy, PET scan
- Keywords
- Mediastinal lymphadenopathy, PET CT to 18FDG, EUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided punction of mediastinal lymphadenopathy by echoendoscopyProcedure or surgery
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 scanDevice
The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts
| Study group | Role | What they receive |
|---|---|---|
| hypermetabolic mediastinal lymph nodes in PET, | Other | hypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence. Receives: Procedure: Guided punction of mediastinal lymphadenopathy by echoendoscopy; Device: PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (3)
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)
Measured: 12 months
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
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study start8 Jan 2013
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypermetabolic Lymphadenopathy Mediastinum Lower, Posterior and Middle, Detected by PET-CT With 18F-FDG (PET)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892501
- Sponsor's protocol ID
- IB 2012-01
- Acronym
- APOGEE
- Status last verified
- Apr 2021
- First submitted
- 26 Jun 2013
- Last updated
- 3 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 35341993
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT01892501
- Acronym / sponsor ID
- APOGEE / IB 2012-01
- Keywords
- Mediastinal lymphadenopathy, PET CT to 18FDG, EUS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- 8 Jan 2013 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 4 Jul 2013 (estimated)
- Results
- Posted 27 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Group A biopsy is surgically feasible
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypermetabolic mediastinal lymph nodes in PET, | Other | Procedure: Guided punction of mediastinal lymphadenopathy by echoendoscopy, Device: PET scanhypermetabolic mediastinal lymph nodes in PET,in a context of New cancer or cancer recurrence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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 :
- PET, the result is positive :
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided punction of mediastinal lymphadenopathy by echoendoscopyEUS (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. | Procedure or surgery | hypermetabolic mediastinal lymph nodes in PET, |
| PET scanThe benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts | Device | hypermetabolic mediastinal lymph nodes in PET, |
Primary outcome
Sensitivity of Endoscopic Ultrasound-guided (EUS-guided) Puncture
Time frame: 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).
3 secondary outcomes
Negative Predictive Value
Time frame: 12 months
Matching Between Therapeutic Strategies RCP1/RCP2
Time frame: 12 months
Clinical Utility (Avoid More Invasive Procedure)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35341993Bechade 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided punction of mediastinal lymphadenopathy by echoendoscopy and PET scan in people with Hypermetabolic Lymphadenopathy Mediastinum Lower, Posterior and Middle, Detected by PET-CT With 18F-FDG (PET), run by Institut Bergonié at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Endoscopic Ultrasound-guided (EUS-guided) Puncture (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01892501, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.