NCT02111824

Brief Summary

The goal of this clinical research study is to test the use of a minimally invasive multimodality image-guided (MIMIG) intervention system used for performing a lung biopsy. The safety of the MIMIG intervention system will also be studied.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

January 5, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

5.8 years

First QC Date

April 9, 2014

Last Update Submit

September 10, 2021

Conditions

Lung NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung Diseases

Keywords

Lung CancerPeripheral lung lesionsLung biopsyMinimally invasivemultimodality image-guided intervention systemMIMIGIndocyanine greenICG

Outcome Measures

Primary Outcomes (1)

  • Technical Success Rate of Biopsy Using the MIMIG system With + Without Fiber-Optical Imaging

    Technical success rate of completing the biopsy procedure using the MIMIG system with and without fiber-optical imaging measured where technical success is defined as the ability to use the navigational components of the MIMIG system to obtain a tissue specimen from a lung nodule; ability to use the navigational components of the system during the biopsy procedure, the ability to successfully perform optical imaging of the lung nodule and the ability to obtain a tissue specimen from the lung nodule.

    3 Mos

Study Arms (3)

Group 2

EXPERIMENTAL

During standard of care lung biopsy, the doctor will use the MIMIG system to help guide the needle for the the lung biopsy.

Device: MIMIG System

Group 3

EXPERIMENTAL

During standard of care lung biopsy, the doctor will use the MIMIG system to help guide the needle for the lung biopsy. An intravenous (IV) needle placed in the vein to give indocyanine green (IC-Green). Fiber Optic camera will be used to view tissue before biopsy via insertion catheter.

Device: MIMIG SystemDrug: Indocyanine Green (ICG)

Group 1

NO INTERVENTION

Control Group consists of twelve patients who have undergone biopsy of a peripheral lung lesion by using repetitive CT-guidance. Review of medical records only, no further intervention.

Interventions

MIMIG SystemDEVICE

Minimally Invasive MultiModality Imaging Guidance System (MIMIG)

Also known as: Dell Workstation T5500, HP Monitor- LP3065, Aurora Field Generator- A4-00207, Aurora System Control Unit- F4-00275, Aurora Sensor Interface Unit- S4-00556, Introducer Needle- TRAXTAL, Reference- TRAXTAL, Surface Fiducials - Traxtal, Foot Switch- Herge Electric Ltd- 6221-0019
Group 2Group 3
Indocyanine Green (ICG)DRUG

Use of ICG as staining for fiberoptic visualization of lung tissue via introducer needle prior to obtaining tissue samples.

Also known as: indocyanine green (IC-Green)., 3 mg/kg by vein before lung biopsy., Indocyanine green, IC-Green, ICG
Group 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (age ≥ 18 years) subjects with peripheral lung lesions that are \<1.5 cm in size who are planning to undergo percutaneous image guided lung biopsy as part of their routine medical care.
  • \. Ability to understand and willingness to sign Informed Consent Document (ICD)

You may not qualify if:

  • Age less than 18 years.
  • Pregnant or nursing females.
  • Known allergy to iodine or intravenous contrast agent.
  • Known allergy or anaphylactic reaction to indocyanine green (ICG).
  • Patients with renal dysfunction (GFR \<60) or patients on dialysis
  • Patients with liver dysfunction: total bilirubin \> 2.5 mg/dl; albumin \< 2.5 mg/dl; alanine aminotransferase (ALT), aspartate aminotransferase (AST) \> 5 times upper limits of normal
  • Uncorrectable coagulopathy prohibiting biopsy. (INR \> 1.5 and/ or platelets \< 50,000)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center Interventional Radiology Dept.

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung Diseases

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Alda Tam, MD

    MD Anderson Cancer Center Interventional Radiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 9, 2014

First Posted

April 11, 2014

Study Start

January 5, 2014

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

September 17, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)