NCT02383628

Brief Summary

The main objective of the study is to evaluate the efficacy of indocyanine green (ICG) endoscopy to evaluate tissue perfusion during endoscopic neurosurgery. This includes patients with pituitary and intracranial tumors and treatment of vascular abnormalities such as aneurysms and compressive syndromes. ICG will be evaluated to determine the value of the additional visual information supplied during the treatment of these pathologies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

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

First Submitted

Initial submission to the registry

March 3, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 5, 2018

Status Verified

July 1, 2018

Enrollment Period

2.7 years

First QC Date

March 3, 2015

Last Update Submit

July 3, 2018

Conditions

Quality of Life

Keywords

ICG Dyeendoscopic neurosurgerytissue perfusion

Outcome Measures

Primary Outcomes (1)

  • Efficacy as measured by observation

    compare efficacy of tissue perfusion with and without ICG Dye and light filter

    up to 52 weeks

Eligibility Criteria

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

Patient population would include those patients with pituitary tumors, intracranial tumors, aneurysms, and normal tissue adjacent to tumors to clarify normal from abnormal. Also, patients with compressive syndromes to ensure patency of normal vessels. This would be all patients undergoing endoscopic surgery, both endonasal and open (retromastoid or transcranial).

You may qualify if:

  • Patient population would include those patients with pituitary tumors, intracranial tumors, aneurysms, and normal tissue adjacent to tumors to clarify normal from abnormal. Also, patients with compressive syndromes to ensure patency of normal vessels. This would be all patients undergoing endoscopic surgery, both endonasal and open (retromastoid or transcranial).

You may not qualify if:

  • Less than 18 years of age
  • Iodine allergy
  • Shellfish allergy
  • Contrast allergy
  • Previous anaphylactic reaction to ICG
  • Pregnant
  • Anyone with any evidence of renal or hepatic dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

  • Paul Gardner, MD

    University of Pittsburgh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 3, 2015

First Posted

March 9, 2015

Study Start

October 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

July 5, 2018

Record last verified: 2018-07

Locations

US(1)