Pleural EffusionNCT03656822
Data Visualization of Kidney and Prostate Tumors Using Routine Pre-Operative Imaging, 3D Printed, and 3D Virtual Reality Models
An observational study of Pleural Effusion, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to determine whether adding new methods of data visualization to routine clinical care will improve (i) surgical planning and (ii) surgical outcomes in patients with kidney and prostate tumors. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Routine CT, Routine imaging CT with a 3D printed model and Routine imaging MRI with a 3D printed model
- How many people
- 303 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2017to 31 Dec 2019
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have scheduled to have kidney or prostate cancer surgery
Who may be able to join
- Outpatients with MPE undergoing IPC placement
- Sufficient mental capacity to provide informed consent and answer Short-Form Six-Dimension health index (SF-6D) and Borg score questions
Who cannot join
- Patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax)
- Inability or unwillingness to give informed consent
- Inability to perform phone call and clinical follow-up at MD Anderson Cancer Center (MDACC)
- Pregnancy
- Previous intrapleural therapy for MPE on the same side
- Eastern Cooperative Oncology Group (ECOG) of 4 and life expectancy ≤ 2 weeks
Show all 9Show fewer
- Doxycycline allergy
- Extensive loculations or hydropneumothorax or other contraindication to pleurodesis
- Chylous effusions associated with malignant disease
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
The purpose of this study is to determine whether adding new methods of data visualization to routine clinical care will improve (i) surgical planning and (ii) surgical outcomes in patients with kidney and prostate tumors.
Read the detailed description
This early phase I trial studies how well indwelling pleural catheters with doxycycline work compared to indwelling pleural catheters alone in treating participants with malignant pleural effusions. These types of catheters are commonly used to treat pleural effusions (build-up of fluid in the lungs). Doxycycline is an antibiotic that is also used to treat pleural effusions. It is not yet known whether giving doxycycline with indwelling pleural catheters works better than indwelling pleural catheters alone in treating participants with cancerous pleural effusions.
- Conditions
- Pleural Effusion
- Being tested
- Routine CT, Routine imaging CT with a 3D printed model, Routine imaging MRI with a 3D printed model, Routine MRI, Routine imaging CT with a VR model
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine CTDiagnostic test
CAT (Computerized Axial Tomography) scan, is a noninvasive X-ray test that is used to diagnose a variety of medical conditions.
Routine imaging CT with a 3D printed modelDiagnostic test
CAT (Computerized Axial Tomography) scan, is a noninvasive X-ray test that is used to diagnose a variety of medical conditions + 3D Printed Model
Routine imaging MRI with a 3D printed modelDiagnostic test
will measure post-operative lesion volume as visualized on the post-operative MRI + 3D Printed Model
Routine MRIDiagnostic test
will measure post-operative lesion volume as visualized on the post-operative MRI
Routine imaging CT with a VR modelDiagnostic test
CAT (Computerized Axial Tomography) scan, is a noninvasive X-ray test that is used to diagnose a variety of medical conditions + VR Model
Routine imaging MRI with a VR modelDiagnostic test
will measure post-operative lesion volume as visualized on the post-operative MRI + VR Model
| Study group | Role | What they receive |
|---|---|---|
| Routine imaging such as CT or MRI | Subjects will undergo routine pre-operative imaging and will be randomized into 3 groups for data visualization. This group will receive data visualization using routine clinical imaging, Receives: Diagnostic Test: Routine CT; Diagnostic Test: Routine MRI | |
| Routine imaging (CT or MRI) with a 3D printed model | Subjects will undergo routine pre-operative imaging and will be randomized into 3 groups for data visualization. This group will receive data visualization using routine clinical imaging with a 3D printed anatomical mode Receives: Diagnostic Test: Routine imaging CT with a 3D printed model; Diagnostic Test: Routine imaging MRI with a 3D printed model | |
| Routine imaging (CT or MRI) with a VR model | Subjects will undergo routine pre-operative imaging and will be randomized into 3 groups for data visualization. This group will receive data visualization using routine clinical imaging with a 3D VR anatomical model Receives: Diagnostic Test: Routine imaging CT with a VR model; Diagnostic Test: Routine imaging MRI with a VR model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Operative Time
measure of the amount of time it takes surgeon to remove tumor
Measured: Post Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start7 Feb 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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 NYU Langone HealthThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hersh Chandarana, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656822
- Sponsor's protocol ID
- 16-00697
- Status last verified
- Feb 2020
- First submitted
- 30 Aug 2018
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Visualization of Kidney and Prostate Tumors Using Routine Pre-Operative Imaging, 3D Printed, and 3D Virtual Reality Models
- ClinicalTrials.gov ID
- NCT03656822
- Acronym / sponsor ID
- 16-00697
- Conditions
- Pleural Effusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 4 Sep 2018 (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.
The purpose of this study is to determine whether adding new methods of data visualization to routine clinical care will improve (i) surgical planning and (ii) surgical outcomes in patients with kidney and prostate tumors.
Detailed description
This early phase I trial studies how well indwelling pleural catheters with doxycycline work compared to indwelling pleural catheters alone in treating participants with malignant pleural effusions. These types of catheters are commonly used to treat pleural effusions (build-up of fluid in the lungs). Doxycycline is an antibiotic that is also used to treat pleural effusions. It is not yet known whether giving doxycycline with indwelling pleural catheters works better than indwelling pleural catheters alone in treating participants with cancerous pleural effusions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Routine imaging such as CT or MRI | – | Diagnostic Test: Routine CT, Diagnostic Test: Routine MRISubjects will undergo routine pre-operative imaging and will be randomized into 3 groups for data visualization. This group will receive data visualization using routine clinical imaging, |
| Routine imaging (CT or MRI) with a 3D printed model | – | Diagnostic Test: Routine imaging CT with a 3D printed model, Diagnostic Test: Routine imaging MRI with a 3D printed modelSubjects will undergo routine pre-operative imaging and will be randomized into 3 groups for data visualization. This group will receive data visualization using routine clinical imaging with a 3D printed anatomical mode |
| Routine imaging (CT or MRI) with a VR model | – | Diagnostic Test: Routine imaging CT with a VR model, Diagnostic Test: Routine imaging MRI with a VR modelSubjects will undergo routine pre-operative imaging and will be randomized into 3 groups for data visualization. This group will receive data visualization using routine clinical imaging with a 3D VR anatomical model |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have scheduled to have kidney or prostate cancer surgery
Key inclusion criteria (2 listed)
- Outpatients with MPE undergoing IPC placement
- Sufficient mental capacity to provide informed consent and answer Short-Form Six-Dimension health index (SF-6D) and Borg score questions
Key exclusion criteria (9 listed)
- Patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax)
- Inability or unwillingness to give informed consent
- Inability to perform phone call and clinical follow-up at MD Anderson Cancer Center (MDACC)
- Pregnancy
- Previous intrapleural therapy for MPE on the same side
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 |
|---|---|---|
| Routine CTCAT (Computerized Axial Tomography) scan, is a noninvasive X-ray test that is used to diagnose a variety of medical conditions. | Diagnostic test | Routine imaging such as CT or MRI |
| Routine imaging CT with a 3D printed modelCAT (Computerized Axial Tomography) scan, is a noninvasive X-ray test that is used to diagnose a variety of medical conditions + 3D Printed Model | Diagnostic test | Routine imaging (CT or MRI) with a 3D printed model |
| Routine imaging MRI with a 3D printed modelwill measure post-operative lesion volume as visualized on the post-operative MRI + 3D Printed Model | Diagnostic test | Routine imaging (CT or MRI) with a 3D printed model |
| Routine MRIwill measure post-operative lesion volume as visualized on the post-operative MRI | Diagnostic test | Routine imaging such as CT or MRI |
| Routine imaging CT with a VR modelCAT (Computerized Axial Tomography) scan, is a noninvasive X-ray test that is used to diagnose a variety of medical conditions + VR Model | Diagnostic test | Routine imaging (CT or MRI) with a VR model |
| Routine imaging MRI with a VR modelwill measure post-operative lesion volume as visualized on the post-operative MRI + VR Model | Diagnostic test | Routine imaging (CT or MRI) with a VR model |
Primary outcome
Measure of Operative Time
Time frame: Post Surgery
measure of the amount of time it takes surgeon to remove tumor
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 6 Feb 2020.
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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.
Hersh Chandarana, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusion, run by NYU Langone Health at 1 site 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 2 inclusion and 9 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 6 Feb 2020. 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 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?
Measure of Operative Time (time frame: Post Surgery). 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 6 Feb 2020; AzTrials last refreshed its copy on 4 Nov 2026.