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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


If you agree to take part in this study, the following information about your routine
standard of care lung biopsy will be collected:

- The accuracy of the procedure

- How long it takes to complete the procedure

- How long the needle is inserted to collect the biopsy sample

- The number of CT scans used during the procedure

- The radiation dose level used

- Any complications and/or side effects you may experience

- The results of the diagnosis from the biopsy sample

Researchers will take appropriate steps to keep your information private. However, there is
no guarantee of absolute privacy. Your information will be kept in a password-protected
computer at MD Anderson for up to 7 years and will only be permitted to be viewed by the
study doctor and members of the research staff.

Group 2:

During your standard of care lung biopsy, the doctor will use the minimally invasive
multimodality image-guided (MIMIG) intervention system to help guide the needle for the
biopsy the lung biopsy.

Group 3:

During your standard of care lung biopsy, the doctor will use the MIMIG intervention system
to help guide the needle for the biopsy the lung biopsy. You will also have an intravenous
(IV) needle placed in your vein to give you indocyanine green (IC-Green). IC-Green is a dye
that allows researchers to see your veins and other organs during the biopsy.

Length of Study:

Your active participation on this study will be over after the lung biopsy procedure is
over.

This is an investigational study. The use of the MIMIG intervention system to help guide
the needle for the lung biopsy is not FDA approved or commercially available. The use of the
MIMIG intervention system is investigational. The tumor that is biopsied will be chosen
based on review of diagnostic images, just as it would be as part of normal care.

Up to 24 patients will take part in this study. All will be enrolled at MD Anderson.


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 > or = 2.5 mg/dl; albumin < or =2.5
mg/dl; alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 5 times
upper limits of normal

7. Uncorrectable coagulopathy prohibiting biopsy.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Marshall Hicks, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2011-0368

NCT ID:

NCT01433822

Start Date:

July 2013

Completion Date:

Related Keywords:

  • Lung Cancer
  • Lung Cancer
  • Peripheral lung lesions
  • Lung biopsy
  • Minimally invasive multimodality image-guided intervention system
  • MIMIG
  • Indocyanine green
  • ICG
  • Lung Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030