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OpenTrials
Completed

NCT Number: NCT03656822

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

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.

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Key information

Conditions

Pleural Effusion Pleural Diseases Respiratory Tract Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Routine CT

Diagnostic Test

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

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

Diagnostic Test

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

Routine MRI

Diagnostic Test

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

Routine imaging CT with a VR model

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

Diagnostic Test

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

Primary outcomes

  1. Measure of Operative Time

    Time frame: Post Surgery

    measure of the amount of time it takes surgeon to remove tumor

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 4, 2018
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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