A Multimodality Image-guided System for Peripheral Lung Cancer Diagnosis and Therapy (MIMIG)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by The Methodist Hospital System
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT02111824
First received: April 9, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Lung Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Device: MIMIG System
Drug: Indocyanine Green (ICG)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Multimodality Image-guided System for Peripheral Lung Cancer Diagnosis and Therapy

Resource links provided by NLM:


Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • Technical Success Rate of Biopsy Using the MIMIG system With + Without Fiber-Optical Imaging [ Time Frame: 3 Mos ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 36
Study Start Date: April 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 2
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
Minimally Invasive MultiModality Imaging Guidance System (MIMIG)
Other Names:
  • 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
Experimental: Group 3
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 System
Minimally Invasive MultiModality Imaging Guidance System (MIMIG)
Other Names:
  • 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
Drug: Indocyanine Green (ICG)
Use of ICG as staining for fiberoptic visualization of lung tissue via introducer needle prior to obtaining tissue samples.
Other Names:
  • indocyanine green (IC-Green).
  • 3 mg/kg by vein before lung biopsy.
  • Indocyanine green
  • IC-Green
  • ICG
No Intervention: Group 1
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Ability to understand and willingness to sign Informed Consent Document (ICD)

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02111824

Contacts
Contact: Ada Lo (713) 794-4404 alo@mdanderson.org

Locations
United States, Texas
MD Anderson Cancer Center Interventional Radiology Dept.
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Marshall Hicks, MD MD Anderson Cancer Center Interventional Radiology
  More Information

No publications provided

Responsible Party: The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT02111824     History of Changes
Obsolete Identifiers: NCT01433822
Other Study ID Numbers: MIMIG G130097
Study First Received: April 9, 2014
Last Updated: April 9, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by The Methodist Hospital System:
Lung Cancer
Peripheral lung lesions
Lung biopsy
Minimally invasive
multimodality image-guided intervention system
MIMIG
Indocyanine green
ICG

Additional relevant MeSH terms:
Neoplasms
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Thoracic Neoplasms
Respiratory Tract Diseases
Respiratory Tract Neoplasms

ClinicalTrials.gov processed this record on July 24, 2014