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

Study 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.

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Key things to know

Main goalDiagnostic

This describes the study’s primary purpose.

What is being studiedMIMIG System and Indocyanine Green (ICG)

The study team can explain what participation involves.

Who it may be forLung Neoplasms · Thoracic Neoplasms

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 17, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?The Methodist Hospital Research Institute

Study sponsor

Study overview

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)

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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)

Reasons someone may not be able to joinExclusion 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.

Study sites

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.

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