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

Completed

• Conditions: Pleural Effusion
• Interventions: Diagnostic Test: Routine imaging CT with a 3D printed model; Diagnostic Test: Routine imaging CT with a VR model; Diagnostic Test: Routine CT; Diagnostic Test: Routine imaging MRI with a 3D printed model; Diagnostic Test: Routine imaging MRI with a VR model; Diagnostic Test: Routine MRI

• Registration Number: NCT03656822
• Lead Sponsor: NYU Langone Health

Brief 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.

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 Timeline

• Study Start: 2017-02-07
• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-08-30
• Study First Posted: 2018-09-04
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Routine imaging (CT or MRI) with a 3D printed model	Routine imaging CT 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
Routine imaging (CT or MRI) with a 3D printed model	Routine imaging 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
Routine imaging (CT or MRI) with a VR model	Routine imaging CT 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
Routine imaging such as CT or MRI	Routine CT	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,
Routine imaging (CT or MRI) with a VR model	Routine imaging 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
Routine imaging such as CT or MRI	Routine 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,

Primary Outcome Measures

Name	Time	Method
Measure of Operative Time	Post Surgery	measure of the amount of time it takes surgeon to remove tumor

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States