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

Stopped early · Phase 1

Conditions studied: Lung Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases

In brief

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.

Key facts

Study ID

NCT02111824

Run by

The Methodist Hospital Research Institute

People needed

7

Starts

2014-01-05

Expected to finish

2019-11-01

Last updated by the study team

2021-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• MD Anderson Cancer Center Interventional Radiology Dept. — Houston, Texas, United States

Full record on ClinicalTrials.gov

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