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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
The Methodist Hospital System
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01433822
First received: September 8, 2011
Last updated: October 14, 2013
Last verified: October 2013
  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 Cancer
Procedure: Biopsy With Fiber-Optical Imaging
Procedure: Biopsy Without Fiber-Optical Imaging
Other: 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 M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Technical Success Rate of Biopsy Using the MIMIG system With + Without Fiber-Optical Imaging [ Time Frame: 3 months ] [ 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.


Enrollment: 0
Study Start Date: November 2013
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MIMIG Guidance System With Fiber-Optical Imaging
MIMIG intervention system used to guide needle for lung biopsy during standard of care lung biopsy.
Procedure: Biopsy With Fiber-Optical Imaging
During standard of care lung biopsy, the doctor will use the MIMIG intervention system to help guide the needle for the the lung biopsy.
Experimental: MIMIG Guidance System Without Fiber-Optical Imaging
MIMIG intervention system + indocyanine green (IC-Green).
Procedure: Biopsy Without Fiber-Optical Imaging
During standard of care lung biopsy, the doctor will use the MIMIG intervention system to help guide the needle for the lung biopsy. An intravenous (IV) needle placed in the vein to give indocyanine green (IC-Green).
Other: ICG
3 mg/kg by vein before lung biopsy.
Other Names:
  • Indocyanine green
  • IC-Green
  • ICG
No Intervention: Control Group
Control Group consists of twelve patients who have undergone biopsy of a peripheral lung lesion by using repetitive CT-guidance.

  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:

  1. Age less than 18 years.
  2. Pregnant or nursing females.
  3. Known allergy to iodine or intravenous contrast agent.
  4. Known allergy or anaphylactic reaction to indocyanine green (ICG).
  5. Patients with renal dysfunction (GFR <60) or patients on dialysis
  6. 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
  7. Uncorrectable coagulopathy prohibiting biopsy. (INR > 1.5 and/ or platelets < 50,000)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433822

Sponsors and Collaborators
M.D. Anderson Cancer Center
The Methodist Hospital System
Investigators
Principal Investigator: Marshall Hicks, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01433822     History of Changes
Other Study ID Numbers: 2011-0368
Study First Received: September 8, 2011
Last Updated: October 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Lung Cancer
Peripheral lung lesions
Lung biopsy
Minimally invasive multimodality image-guided intervention system
MIMIG
Indocyanine green
ICG

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

ClinicalTrials.gov processed this record on April 17, 2014