Non-invasive Fluorescent Imaging System for Imaging Mohs Tumor

NCT03430934 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 2009753
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to correlate traditional histological Mohs tissue mapping of a cutaneous tumor with the ICG-mapping procedure. The use of intradermal ICG in a cutaneous tumor during MMS followed by visualization using a fluorescent imaging system could allow surgeons to directly visualize, and roughly map the extent of a primary skin cancer and plan the Mohs procedure (i.e. the initial excision size and subsequent layer widths) accordingly.

Conditions

Skin Cancer

Keywords

Mohs tumor

Outcome Measures

Primary Outcomes (1)

• Near Infra-Red Navigation (NAVI) System for Mohs Tumor Mapping

  Correlation of traditional histological Mohs tissue mapping of a cutaneous tumor with the ICG-mapping procedure.

  24 HOURS

Study Arms (1)

NAVI mapping with Indocyanine green

EXPERIMENTAL

Participants will undergo their scheduled Mohs surgery with the addition of the NAVI mapping with ICG dye

Combination Product: NAVI mapping with Indocyanine green

Interventions

NAVI mapping with Indocyanine green COMBINATION_PRODUCT

Moh's tumor imaging with Indocyanine green

Also known as: Imaging of skin tumor, Indocyanine green

NAVI mapping with Indocyanine green

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are scheduled to undergo Mohs surgery for a basal cell carcinoma tumor, with a minimum tumor size of 1.5 cm, will be selected for the study procedure. A total of 10 subjects are required to complete the study. We will need to consent 15 subjects to achieve a total of 10 subjects to complete the study.
• Individuals 18 years or older
• All races and ethnicity
• Smokers and non-smokers

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Golda Nicholas, MD

  573-882-8578

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Evaluation of a in-house developed Near Infrared Navigation System camera for Moh's tumor

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 13, 2018
• Study Start: July 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: December 9, 2021

Record last verified: 2021-12

Locations

US (1)