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CompletedNCT02280954818012Updated Mar 20, 2018

Indocyanine Green for Solid Tumors

A Phase 1 interventional study of Indocyanine Green (ICG) in Solid Tumor and Neoplasms, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-20.

Sponsored by University of Pennsylvania · Phase 1, Interventional, and Diagnostic

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Solid Tumor
  • Neoplasms

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Keywords

  • Solid Tumor
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In context

Neoplasms

9,371 studies on the registry are indexed under Neoplasms; 2,492 are open to participants now.

This study's enrollment of 48 is close to the median of 50 across 7,258 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
  2. Subjects with a history of iodide allergies
  3. Vulnerable patient populations

    1. People who would be easily lost to follow up
    2. Patients unable to participate in the consent process (children and neonates).
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Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    ICG injection group

    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

  • DrugIndocyanine Green (ICG)

    Also known as: ICG

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What researchers measure

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.

    Time frame: Before surgery

Secondary outcomes

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

    Time frame: Day 1-Day 30

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Study locations

1 site
  • Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
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References and documents

Publications

  • 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. PubMed 30028985 ↗
  • 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. PubMed 28387632 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02280954
Lead sponsor
University of Pennsylvania
Responsible party
Sunil Singhall (Assistant Proffesor of Medicine, Assistant Proffesor of Surgery, Director Thoracic Surgery Research Lab, University of Pennsylvania) — Principal investigator
First posted
Nov 2, 2014
Start date
Nov 2013
Primary completion
Feb 2017
Completion
Feb 2017
Last update
Mar 20, 2018

Study contacts

Sunil Singhal, M.D.
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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