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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01424 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 56617 | Other Identifier | Roswell Park Cancer Institute | |
| R01CA204636 | U.S. NIH Grant/Contract | View source |
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Diagnostic issues
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot trial studies how well photoacoustic imaging works in diagnosing changes in tumors in participants with breast cancer, sarcoma, skin cancer, or soft tissue malignancy and healthy volunteers. Photoacoustic imaging is a low-risk imaging method that provides information about the oxygenation of tissues using a combination of light and ultrasound techniques. Photoacoustic imaging uses a signal from hemoglobin to provide information on blood flow and oxygen levels, and it may be helpful in determining changes in tumors after chemotherapy or radiation treatment.
PRIMARY OBJECTIVES:
I. To define the feasibility of the current photoacoustic imaging (PAI) technology in various groups of human subjects.
SECONDARY OBJECTIVES:
I. To define the utility of the current PAI on various groups of human subjects.
II. When possible, via means of an existing data review, PAI will be correlated with standard imaging modalities performed on patients as routine part of clinical care or on protocol.
III. When possible, via means of an existing data review, PAI will be compared to pathologic specimens.
IV. When possible, via means of an existing data review, PAI data will be correlated with outcomes of patients to therapies they receive.
OUTLINE:
Participants undergo PAI on different parts of the body over 20 minutes for up to 5 imaging sessions for 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (photoacoustic imaging) | Experimental | Participants undergo PAI on different parts of the body over 20 minutes for up to 5 imaging sessions for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photoacoustic Imaging | Procedure | Undergo PAI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics | This will be deemed a success if at least 3 imaging sessions produce a usable image. Usable datasets will be defined as those images with detectable PAI signal with minimal or no artifacts within the region of interest. This analysis will be done in the imaged sample, consisting of enrolled patients who attempt at least one imaging session. Patients who do not attempt at least one imaging session will be replaced. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Utility of serial PAI measurements | This will be explored by comparison with disease and outcome characteristics collected during routine cancer treatment, including standard imaging modalities, pathology results, and clinical outcomes. Results of these analyses are intended to inform development of early stage (Phase 1/2) clinical trials that consider PAI summaries as biomarkers for treatment response. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anurag Singh | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| Up to 6 months |
| Serial PAI oxygenation measurements | This will be correlated with disease and patient characteristics using Analysis of Variance (ANOVA ) for categorical factors | Up to 6 months |
| Serial PAI oxygenation measurements | This will be correlated with disease and patient characteristics using OLS regression for continuous factors | Up to 6 months |
| Serial PAI oxygenation measurements | This will be correlated with disease and patient characteristics using Cox Regression models for progression and overall survival. | Up to 6 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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