A Multimodality Image-guided System for Peripheral Lung Cancer Diagnosis and Therapy
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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: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | A Multimodality Image-guided System for Peripheral Lung Cancer Diagnosis and Therapy |
- 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.
| Estimated Enrollment: | 24 |
| Study Start Date: | July 2013 |
| Estimated Primary Completion Date: | July 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:
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Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
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 > or = 2.5 mg/dl; albumin < or =2.5 mg/dl; alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 5 times upper limits of normal
- Uncorrectable coagulopathy prohibiting biopsy.
Contacts and Locations| Contact: Marshall Hicks, MD | 713-745-2525 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| 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: | March 4, 2013 |
| Health Authority: | United States: Institutional Review Board |
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 May 23, 2013