Pleural EffusionPERFECT-MPENCT06892691
Pleuroscopy First Versus Thoracentesis First in Patients With Suspected Malignant Pleural Effusions
A study testing Pleuroscopy first and Thoracentesis first in people with Pleural Effusion and Cancer, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
This is a randomized control trial of patients with suspected malignant pleural effusions to compare whether patients who have a thoracentesis or pleuroscopy (pleural biopsy) obtain an adequate biopsy, achieve a diagnosis, and begin cancer-directed therapy faster. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Cancer
- What is being tested?
- Pleuroscopy first and Thoracentesis first
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Mar 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Referral for diagnostic pleural procedure.
- Age ≥ 18 years.
- Suspected malignant pleural effusion (Suggestive radiologic appearance (based on computed tomography or positron emission tomography) OR suspected cancer with associated effusion.)
Who cannot join
- Inability to provide informed consent.
- Needs emergent drainage.
- Pleural effusion is known to be malignant.
- Suspected transudative, infectious or inflammatory effusion etiology.
- Having prior inconclusive/non-diagnostic thoracentesis or pleuroscopy.
- Patient is deemed by the clinical team to be more appropriate for VATS biopsy.
- Terminally ill patients in whom a diagnosis will not change management, or who is unlikely to be a candidate for oncological treatment due to significant comorbidities.
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mount Sinai West
New York, New York, 10019
Mount Sinai Hospital
New York, New York, 10029
About this study
This is a randomized control trial of patients with suspected malignant pleural effusions to compare whether patients who have a thoracentesis or pleuroscopy (pleural biopsy) obtain an adequate biopsy, achieve a diagnosis, and begin cancer-directed therapy faster.
Read the detailed description
This is a randomized control trial of patients with suspected malignant pleural effusions comparing patients who undergo either pleuroscopy or thoracentesis as the first diagnostic test. Both procedures are considered standard of care for this diagnosis but it is unknown which one provides more adequate biopsy samples and achieves faster diagnosis and shorter time to oncologic treatment. Currently, most patients undergo thoracentesis first and, if this is inadequate for diagnosis, they then undergo pleuroscopy for further biopsy samples. This study seeks to assess whether patients who undergo pleuroscopy as the first test obtain adequate biopsy samples and a faster path to further oncologic care compared to patients who undergo thoracentesis first. Patients will be recruited and randomized in a 1:1 manner.
Ultrasound is routinely used prior to the procedure and a chest x-ray is done after the procedure. Any other imaging will be determined by clinic need only. No imaging will be done for research purposes. No additional samples will be collected other than what is necessary for diagnostic purposes. In patients who have a non-diagnostic thoracentesis, the participants will be referred for pleuroscopy as the next diagnostic step. In the rare case that pleuroscopy does not achieve adequate diagnosis, the next step would be a liquid biopsy (non-invasive serologic testing for oncologic markers.) The need for liquid biopsy in participants in this study will be determined on a case-by-case basis depending on the clinical concern for malignancy.
- Conditions
- Pleural Effusion, Cancer
- Being tested
- Pleuroscopy first, Thoracentesis first
- Medical subject headings
- Pleural Effusion, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleuroscopy firstProcedure or surgery
Pleuroscopies are performed under moderate sedation with local anesthesia. Through a 1-cm incision a camera is introduced into the pleural space and the space is inspected after draining all fluid. Targeted biopsies under direct visualization are obtained using forceps. The aspirated fluid and biopsies obtained are sent to the cytology and pathology laboratories for analysis.
Thoracentesis firstProcedure or surgery
Thoracenteses are performed under local anesthesia with the insertion of a 5-8Fr catheter into the pleural space. The aspirated fluid obtained is sent to the cytology laboratory for analysis.
| Study group | Role | What they receive |
|---|---|---|
| Pleuroscopy first | Active comparator | Participants will undergo pleuroscopy first Receives: Procedure: Pleuroscopy first |
| Thoracentesis first | Active comparator | Participants will undergo thoracentesis first Receives: Procedure: Thoracentesis first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of biopsies adequate for definitive diagnosis
Proportion of biopsies adequate for definitive diagnosis
Measured: 6 months
Secondary outcomes (8)
Time from initial visit with pulmonologist to procedure
Time from initial visit with pulmonologist to procedure
Measured: 6 months
Time from initial procedure to diagnosis
Time from initial procedure to diagnosis
Measured: 6 months
Time from initial visit with pulmonologist to diagnosis
Time from initial visit with pulmonologist to diagnosis
Measured: 6 months
Time from initial visit with pulmonologist to seeing oncologist
Time from initial visit with pulmonologist to seeing oncologist
Measured: 6 months
Time from initial visit with pulmonologist to starting treatment
Time from initial visit with pulmonologist to starting treatment
Measured: 6 months
Time from seeing oncologist to starting treatment
Time from seeing oncologist to starting treatment
Measured: 6 months
Frequency of procedure-related complications
Frequency of procedure-related complications
Measured: 6 months
Frequency of additional diagnostic testing
Frequency of additional diagnostic testing
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start19 Mar 2025
- Primary completion30 Aug 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to undergo either pleuroscopy first or thoracentesis first.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Udit Chaddha, Icahn School of Medicine at Mount Sinai
- Investigators
- Udit Chaddha, MBBS, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892691
- Sponsor's protocol ID
- STUDY-24-00999
- Acronym
- PERFECT-MPE
- Status last verified
- Oct 2026
- First submitted
- 19 Mar 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pleuroscopy First Versus Thoracentesis First in Patients With Suspected Malignant Pleural Effusions
- ClinicalTrials.gov ID
- NCT06892691
- Acronym / sponsor ID
- PERFECT-MPE / STUDY-24-00999
- Conditions
- Pleural Effusion, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized control trial of patients with suspected malignant pleural effusions to compare whether patients who have a thoracentesis or pleuroscopy (pleural biopsy) obtain an adequate biopsy, achieve a diagnosis, and begin cancer-directed therapy faster.
Detailed description
This is a randomized control trial of patients with suspected malignant pleural effusions comparing patients who undergo either pleuroscopy or thoracentesis as the first diagnostic test. Both procedures are considered standard of care for this diagnosis but it is unknown which one provides more adequate biopsy samples and achieves faster diagnosis and shorter time to oncologic treatment. Currently, most patients undergo thoracentesis first and, if this is inadequate for diagnosis, they then undergo pleuroscopy for further biopsy samples. This study seeks to assess whether patients who undergo pleuroscopy as the first test obtain adequate biopsy samples and a faster path to further oncologic care compared to patients who undergo thoracentesis first. Patients will be recruited and randomized in a 1:1 manner.
Ultrasound is routinely used prior to the procedure and a chest x-ray is done after the procedure. Any other imaging will be determined by clinic need only. No imaging will be done for research purposes. No additional samples will be collected other than what is necessary for diagnostic purposes. In patients who have a non-diagnostic thoracentesis, the participants will be referred for pleuroscopy as the next diagnostic step. In the rare case that pleuroscopy does not achieve adequate diagnosis, the next step would be a liquid biopsy (non-invasive serologic testing for oncologic markers.) The need for liquid biopsy in participants in this study will be determined on a case-by-case basis depending on the clinical concern for malignancy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to undergo either pleuroscopy first or thoracentesis first.
| Arm | Type | Receives |
|---|---|---|
| Pleuroscopy first | Active comparator | Procedure: Pleuroscopy firstParticipants will undergo pleuroscopy first |
| Thoracentesis first | Active comparator | Procedure: Thoracentesis firstParticipants will undergo thoracentesis first |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Referral for diagnostic pleural procedure.
- Age ≥ 18 years.
- Suspected malignant pleural effusion (Suggestive radiologic appearance (based on computed tomography or positron emission tomography) OR suspected cancer with associated effusion.)
Key exclusion criteria (8 listed)
- Inability to provide informed consent.
- Needs emergent drainage.
- Pleural effusion is known to be malignant.
- Suspected transudative, infectious or inflammatory effusion etiology.
- Having prior inconclusive/non-diagnostic thoracentesis or pleuroscopy.
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 |
|---|---|---|
| Pleuroscopy firstPleuroscopies are performed under moderate sedation with local anesthesia. Through a 1-cm incision a camera is introduced into the pleural space and the space is inspected after draining all fluid. Targeted biopsies under direct visualization are obtained using forceps. The aspirated fluid and biopsies obtained are sent to the cytology and pathology laboratories for analysis. | Procedure or surgery | Pleuroscopy first |
| Thoracentesis firstThoracenteses are performed under local anesthesia with the insertion of a 5-8Fr catheter into the pleural space. The aspirated fluid obtained is sent to the cytology laboratory for analysis. | Procedure or surgery | Thoracentesis first |
Primary outcome
Proportion of biopsies adequate for definitive diagnosis
Time frame: 6 months
Proportion of biopsies adequate for definitive diagnosis
8 secondary outcomes
Time from initial visit with pulmonologist to procedure
Time frame: 6 months
Time from initial procedure to diagnosis
Time frame: 6 months
Time from initial visit with pulmonologist to diagnosis
Time frame: 6 months
Time from initial visit with pulmonologist to seeing oncologist
Time frame: 6 months
Time from initial visit with pulmonologist to starting treatment
Time frame: 6 months
Time from seeing oncologist to starting treatment
Time frame: 6 months
Frequency of procedure-related complications
Time frame: 6 months
Frequency of additional diagnostic testing
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
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Active, not recruitingPhase 2
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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.
Udit Chaddha, MBBS principal investigator
MOUNT SINAI HOSPITAL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pleuroscopy first and Thoracentesis first in people with Pleural Effusion and Cancer, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
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 3 inclusion and 8 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 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of biopsies adequate for definitive diagnosis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2026.