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

NYU Langone Health

Status: Completed

Conditions: Pleural Effusion

Treatments: Diagnostic Test: Routine imaging MRI with a 3D printed model; Diagnostic Test: Routine CT; Diagnostic Test: Routine imaging CT with a 3D printed model; Diagnostic Test: Routine MRI; Diagnostic Test: Routine imaging CT with a VR model; Diagnostic Test: Routine imaging MRI with a VR model

Study type: Observational

Funder types: Other

Identifiers

NCT03656822

16-00697

Details and patient eligibility

About

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.

Full 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.

Enrollment: 303 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

303 participants in 3 patient groups

Routine imaging such as CT or MRI

Description:

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,

Treatment:

Diagnostic Test: Routine CT

Diagnostic Test: Routine MRI

Routine imaging (CT or MRI) with a 3D printed model

Description:

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

Treatment:

Diagnostic Test: Routine imaging MRI with a 3D printed model

Diagnostic Test: Routine imaging CT with a 3D printed model

Routine imaging (CT or MRI) with a VR model

Description:

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

Treatment:

Diagnostic Test: Routine imaging CT with a VR model

Diagnostic Test: Routine imaging MRI with a VR model