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

NCT ID: NCT03656822

Last Updated: 2020-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 303 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-07
• Study Completion Date: 2019-12-31

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.

Conditions

Pleural Effusion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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,

Routine CT

Intervention Type: DIAGNOSTIC_TEST

CAT (Computerized Axial Tomography) scan, is a noninvasive X-ray test that is used to diagnose a variety of medical conditions.

Routine MRI

Intervention Type: DIAGNOSTIC_TEST

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

Routine imaging CT with a 3D printed model

Intervention Type: DIAGNOSTIC_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 model

Intervention Type: DIAGNOSTIC_TEST

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

Routine imaging CT with a VR model

Intervention Type: DIAGNOSTIC_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 model

Intervention Type: DIAGNOSTIC_TEST

will measure post-operative lesion volume as visualized on the post-operative MRI + VR Model

Interventions

Routine CT

CAT (Computerized Axial Tomography) scan, is a noninvasive X-ray test that is used to diagnose a variety of medical conditions.

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

Routine imaging MRI with a 3D printed model

will measure post-operative lesion volume as visualized on the post-operative MRI + 3D Printed Model

Intervention Type: DIAGNOSTIC_TEST

Routine MRI

will measure post-operative lesion volume as visualized on the post-operative MRI

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

Routine imaging MRI with a VR model

will measure post-operative lesion volume as visualized on the post-operative MRI + VR Model

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hersh Chandarana, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

16-00697

Identifier Type: -

Identifier Source: org_study_id