- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03656822
Data Visualization of Kidney and Prostate Tumors Using Routine Pre-Operative Imaging, 3D Printed, and 3D Virtual Reality Models
February 5, 2020 updated by: NYU Langone Health
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
303
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- New York University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who have scheduled to have kidney or prostate cancer surgery
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Doxycycline allergy
- Extensive loculations or hydropneumothorax or other contraindication to pleurodesis
- Chylous effusions associated with malignant disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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,
|
CAT (Computerized Axial Tomography) scan, is a noninvasive X-ray test that is used to diagnose a variety of medical conditions.
will measure post-operative lesion volume as visualized on the post-operative 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
|
CAT (Computerized Axial Tomography) scan, is a noninvasive X-ray test that is used to diagnose a variety of medical conditions + 3D Printed Model
will measure post-operative lesion volume as visualized on the post-operative MRI + 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
|
CAT (Computerized Axial Tomography) scan, is a noninvasive X-ray test that is used to diagnose a variety of medical conditions + VR Model
will measure post-operative lesion volume as visualized on the post-operative MRI + VR Model
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure of Operative Time
Time Frame: Post Surgery
|
measure of the amount of time it takes surgeon to remove tumor
|
Post Surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hersh Chandarana, MD, NYU Langone Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 7, 2017
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
August 30, 2018
First Submitted That Met QC Criteria
August 30, 2018
First Posted (Actual)
September 4, 2018
Study Record Updates
Last Update Posted (Actual)
February 6, 2020
Last Update Submitted That Met QC Criteria
February 5, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-00697
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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