Clinical trial NCT02111824: A Multimodality Image-guided System for Peripheral Lung Cancer Diagnosis and Therapy
Official title: A Multimodality Image-guided System for Peripheral Lung Cancer Diagnosis and Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Lung Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Keywords: Lung Cancer
Peripheral lung lesions
Lung biopsy
Minimally invasive
multimodality image-guided intervention system
MIMIG
Indocyanine green
ICG
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2014-04-11
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: Group 2:

If the patient agrees to take part in this study, the following information about their 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 the patient may experience The results of the diagnosis from the biopsy sample Researchers will take appropriate steps to keep the patient's information private. However, there is no guarantee of absolute privacy. The patient's 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.

During the patient's routine lung biopsy, the doctor will use the MIMIG intervention system to help guide the needle for the biopsy the lung biopsy.

Length of Study:

The patient's active participation on this study will be over after the lung biopsy procedure is over.

Description of Procedure:

The first CT scan will be used as a map to guide a needle into the tumor with the MIMIG intervention system. After that, a second CT scan will be done to confirm that the needle tip has been properly inserted inside the lung tumor. Based on the results from these images, the tumor will then be biopsied the same way it would be as part of normal routine care.

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.

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

Group 3:

If the patient agrees to take part in this study, the following information about the patient's 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 the patient may experience The results of the diagnosis from the biopsy sample Researchers will take appropriate steps to keep the patient's information private. However, there is no guarantee of absolute privacy. The patient's information will be kept in a password-protected computer at MD Anderson and will only be permitted to be viewed by the study doctor and members of the research staff.

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

Length of Study:

After the lung biopsy is complete, the patient's active participation on this study will be over.

Description of Procedure:

The first CT scan will be used as a map to guide a needle into the tumor with the MIMIG intervention system. After that, a second CT scan will be done to confirm that the needle tip has been properly inserted inside the lung tumor. A fiberoptic endoscope (a small camera with a light) will be inserted through the CT guided needle to the tumor to help doctors see the tumor blood vessels. IC-Green will also be given by IV to allow doctors to see the blood vessels of the tumor. Based on the results from these images, the tumor will then be biopsied the same way it would be as part of normal routine care.

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 use of fiberoptic endoscope for lung tumor vessels imaging is not FDA approved or commercially available. The use of fiberoptic endoscope is investigational. The use of IC-Green in combination with fiberoptic endoscope for lung tumor vessels imaging is not FDA approved or commercially available. The use of IC-Green in combination with fiberoptic endoscope is investigational.

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

Eligibility criteria: 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.
* 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)

Primary outcomes:
measure: Technical Success Rate of Biopsy Using the MIMIG system With + Without Fiber-Optical Imaging
timeFrame: 3 Mos
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center Interventional Radiology Dept.
state: Texas
Study officials:
affiliation: MD Anderson Cancer Center Interventional Radiology
name: Alda Tam, MD
role: PRINCIPAL_INVESTIGATOR
References: