NCT03656822

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

2.9 years

First QC Date

August 30, 2018

Last Update Submit

February 5, 2020

Conditions

Pleural Effusion

Outcome Measures

Primary Outcomes (1)

  • Measure of Operative Time

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

    Post Surgery

Study Arms (3)

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 CTDiagnostic Test: Routine 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 modelDiagnostic Test: Routine imaging MRI with a 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 modelDiagnostic Test: Routine imaging MRI with a VR model

Interventions

Routine CTDIAGNOSTIC_TEST

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

Routine imaging such as CT or MRI
Routine imaging CT with a 3D printed modelDIAGNOSTIC_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 (CT or MRI) with a 3D printed model
Routine imaging MRI with a 3D printed modelDIAGNOSTIC_TEST

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

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

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

Routine imaging such as CT or MRI
Routine imaging CT with a VR modelDIAGNOSTIC_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 (CT or MRI) with a VR model
Routine imaging MRI with a VR modelDIAGNOSTIC_TEST

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

Routine imaging (CT or MRI) with a VR model

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have scheduled to have kidney or prostate cancer surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Hersh Chandarana, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2018

First Posted

September 4, 2018

Study Start

February 7, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 6, 2020

Record last verified: 2020-02

Locations

US(1)