A Multimodality Image-guided System for Peripheral Lung Cancer Diagnosis and Therapy
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.
Checked against the public recordLast updated Sep 17, 2021 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Diagnostic
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- The Methodist Hospital Research Institute
- Interventions being studied
- Device: MIMIG System; Drug: Indocyanine Green (ICG)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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)
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- MD Anderson Cancer Center Interventional Radiology Dept.Houston, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 17, 2021. Always confirm current availability with the study team.