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| ID | Type | Description | Link |
|---|---|---|---|
| 818012 [UPenn IRB Protocol#] | Other Identifier | IRB |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine Green (ICG) | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants that will have an adverse reaction to the ICG. | Day 1-Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Sunil Singhal, M.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30028985 | Derived | 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. | |
| 28387632 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 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. |