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

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ClinicalTrials.gov Identifier: NCT03656822
Recruitment Status : Recruiting
First Posted : September 3, 2018
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment
Pleural Effusion Diagnostic Test: Routine CT Diagnostic Test: Routine imaging CT with a 3D printed model Diagnostic Test: Routine imaging MRI 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

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 Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Data Visualization of Kidney and Prostate Tumors Using Routine Pre-Operative Imaging, 3D Printed, and 3D Virtual Reality Models
Actual Study Start Date : February 7, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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,
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.

Diagnostic Test: Routine MRI
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
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

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

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
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

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




Primary Outcome Measures :
  1. Measure of Operative Time [ Time Frame: Post Surgery ]
    measure of the amount of time it takes surgeon to remove tumor



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have scheduled to have kidney or prostate cancer surgery
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656822


Contacts
Contact: Richard Huang 212 263 7729 Richard.Huang@nyumc.org

Locations
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Richard Huang    212-263-7729    Richard.Huang@nyumc.org   
Principal Investigator: Hersh Chandrana, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Hersh Chandarana, MD New York University School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03656822     History of Changes
Other Study ID Numbers: 16-00697
First Posted: September 3, 2018    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Pleural Effusion
Prostatic Neoplasms
Pleural Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases