Data Visualization of Kidney and Prostate Tumors Using Routine Pre-Operative Imaging, 3D Printed, and 3D Virtual Reality Models

Pleural Effusion Clinical Trial

Official title:

Data Visualization of Kidney and Prostate Tumors Using Routine Pre-Operative Imaging, 3D Printed, and 3D Virtual Reality Models

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03656822
• Other study ID #: 16-00697
• Status: Completed
• Start date: February 7, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Pleural Effusion
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Routine CT
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 model
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 model
will measure post-operative lesion volume as visualized on the post-operative MRI + 3D Printed Model
• Routine MRI
will measure post-operative lesion volume as visualized on the post-operative MRI
• Routine imaging CT with a VR model
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 model
will measure post-operative lesion volume as visualized on the post-operative MRI + VR Model

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of Operative Time	measure of the amount of time it takes surgeon to remove tumor	Post Surgery