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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-11126 | Other Identifier | NCI-CTRP Clinical Registry |
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To learn if an investigational imaging device can help to identify tumor tissue before a biopsy is taken.
Primary Objectives
- To determine the feasibility of using an OCT probe that will assess tumor morphology before taking a biopsy core needle. The endpoint for this objective will be the successful placement of the optical probe through the guidance needle and collection of high-quality optical coherence tomography images.
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tVisio-1 | Experimental | The device collects optical coherence tomography (OCT) images in an effort to identify tumor tissue before physical samples are collected. During the biopsy, a sterilized optical imaging probe will be placed through the standard biopsy guidance needle to collect a few images of the tissue at the tip of the biopsy needle. Then the regular biopsy will continue to collect a few biopsy cores. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tVisio-1 | Device | Standard of Care Biopsy |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and adverse events (AEs) | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03 | Through study completion; an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rahul A Sheth, MD | Contact | (713) 745-0652 | rasheth@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Rahul A Sheth, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD 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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