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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-07929 | Other Identifier | NCI-CTRP Clinical Trials Registry | |
| R01DE029590-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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To learn if a new type of imaging device called the Active Biopsy Guidance System can help doctors to decide when and where to perform invasive biopsies of mouth lesions.
Primary objective:
-To evaluate and optimize the technical performance characteristics of an Active Biopsy Guidance System.
Secondary objective:
-To provide a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology. Optical imaging; optical projection of light onto tissue; optical contrast agent (proflavine).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Active Biopsy Guidance System | Experimental | This imaging scanning device is made up of 2 parts: the optical mapping scope and the high-resolution microendoscope (HRME): |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Resolution Microendoscope (HRME) | Device | The High Resolution Microendoscope (HRME) take pictures of a very small area of the lining of the mouth, about the size of a pencil tip, but at high magnification. |
| Measure | Description | Time Frame |
|---|---|---|
| To establish a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology | Through study completion an average of 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ann Gillenwater, MD | Contact | (713) 792-8841 | agillenw@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Ann Gillenwater, MD | MD Anderson Caner Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D011370 | Proflavine |
| ID | Term |
|---|---|
| D000609 | Aminoacridines |
| D000166 | Acridines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Optical Mapping Scope | Device | The optical mapping scope displays a wide area of the lining of the mouth (about the size of the top of a soda can) by shining different colors of light into the mouth and taking pictures. |
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| Proflavine hemisulfate | Drug | A coloring substance (a fluorescent dye which glows green in the dark), called proflavine hemisulfate, will be painted on areas of the mouth with a cotton tip applicator to help improve the pictures |
|
| D006571 | Heterocyclic Compounds |