Overview

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

Status:
Terminated
Trial end date:
2019-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Stephen T. Wong, PhD
The Methodist Hospital Research Institute
Collaborators:
M.D. Anderson Cancer Center
The Methodist Hospital System
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)