NCT02280954

Brief Summary

According to the World Health Organization, cancer is a leading cause of death in men and women, accounting for 7.6 million deaths (around 13% of all deaths) in 2008. Surgery remains the best option for patients presenting with operable Stage I or II cancers, however the five year survival rate for these candidates remains at a dismally low. The high rates of recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin through near-infrared imagery it would be possible for us to improve the rates of recurrence from patients and thus overall survival.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2013

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2013

Completed
12 months until next milestone

First Posted

Study publicly available on registry

November 3, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

3.3 years

First QC Date

November 21, 2013

Last Update Submit

March 16, 2018

Conditions

Solid TumorNeoplasms

Keywords

Solid Tumor

Outcome Measures

Primary Outcomes (1)

  • The ability of the imaging system to detect the expression of the ICG in the nodule/mass (i.e tumor) and discern the uptake of the dye by the tumor.

    Before surgery

Secondary Outcomes (1)

  • The number of participants that will have an adverse reaction to the ICG.

    Day 1-Day 30

Study Arms (1)

ICG injection group

EXPERIMENTAL

This group will receive a single dose of ICG, infused over 40 minutes. During surgery, they will be imaged with a camera and an imaging probe the investigators have developed.

Drug: Indocyanine Green (ICG)

Interventions

Indocyanine Green (ICG)DRUG
Also known as: ICG
ICG injection group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients over 18 years of age
  • Patients presenting with a solid tumor presumed to be resectable cancer and are at risk for local recurrence on pre-operative assessment
  • Good operative candidate as determined by the treating physician and multidisciplinary team
  • Subject capable of giving informed consent and participating in the process of consent.

You may not qualify if:

  • Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
  • Subjects with a history of iodide allergies
  • Vulnerable patient populations
  • People who would be easily lost to follow up
  • Patients unable to participate in the consent process (children and neonates).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • Predina JD, Newton AD, Corbett C, Xia L, Shin M, Sulfyok LF, Okusanya OT, Cengel KA, Haas A, Litzky L, Kucharczuk JC, Singhal S. A Clinical Trial of TumorGlow to Identify Residual Disease During Pleurectomy and Decortication. Ann Thorac Surg. 2019 Jan;107(1):224-232. doi: 10.1016/j.athoracsur.2018.06.015. Epub 2018 Jul 17.

    PMID: 30028985DERIVED

  • Lee JYK, Pierce JT, Thawani JP, Zeh R, Nie S, Martinez-Lage M, Singhal S. Near-infrared fluorescent image-guided surgery for intracranial meningioma. J Neurosurg. 2018 Feb;128(2):380-390. doi: 10.3171/2016.10.JNS161636. Epub 2017 Apr 7.

    PMID: 28387632DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Sunil Singhal, M.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Proffesor of Medicine, Assistant Proffesor of Surgery, Director Thoracic Surgery Research Lab

Study Record Dates

First Submitted

November 21, 2013

First Posted

November 3, 2014

Study Start

November 1, 2013

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 20, 2018

Record last verified: 2018-03

Locations

US(1)