Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA201487-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
The goal of this study is to find out which immune molecules, cells, and genes are involved in the development of lymphedema (LE), so that medicines that target them can be considered for treating lymphedema. The hypothesis is that LE is a systemic, autoimmune-like disease that is initiated by inflammatory cytokines induced by surgery, radiation, and possibly chemotherapy in genetically susceptible patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer-treated patients receiving NIRFLI | Other | Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to "visualize" lymphatic vessel anatomy and function. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine Green (ICG) | Drug | Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to "visualize" lymphatic vessel anatomy and function. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lymphatic propulsive velocity as assessed by NIRFLI | immediately before surgery | |
| Lymphatic propulsive velocity as assessed by NIRFLI | immediately before radiation (which is 6-8 weeks after surgery) | |
| Lymphatic propulsive velocity as assessed by NIRFLI | 6 months after radiation | |
| Lymphatic propulsive velocity as assessed by NIRFLI | 12 months after radiation | |
| Lymphatic propulsive velocity as assessed by NIRFLI | 24 months after radiation | |
| Lymphatic propulsive frequency as assessed by NIRFLI | immediately before surgery | |
| Lymphatic propulsive frequency as assessed by NIRFLI | immediately before radiation (which is 6-8 weeks after surgery) | |
| Lymphatic propulsive frequency as assessed by NIRFLI | 6 months after radiation | |
| Lymphatic propulsive frequency as assessed by NIRFLI | 12 months after radiation | |
| Lymphatic propulsive frequency as assessed by NIRFLI | 24 months after radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Chemokine levels as assessed by bead assay | immediately before surgery | |
| Chemokine levels as assessed by bead assay | immediately before radiation (which is 6-8 weeks after surgery) | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Melissa B Aldrich, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
Not provided
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) | Device | Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to "visualize" lymphatic vessel anatomy and function. |
|
| Percent extravascular dye as assessed by NIRFLI | immediately before surgery |
| Percent extravascular dye as assessed by NIRFLI | immediately before radiation (which is 6-8 weeks after surgery) |
| Percent extravascular dye as assessed by NIRFLI | 6 months after radiation |
| Percent extravascular dye as assessed by NIRFLI | 12 months after radiation |
| Percent extravascular dye as assessed by NIRFLI | 24 months after radiation |
| Vessel tortuosity as assessed by NIRFLI | immediately before surgery |
| Vessel tortuosity as assessed by NIRFLI | immediately before radiation (which is 6-8 weeks after surgery) |
| Vessel tortuosity as assessed by NIRFLI | 6 months after radiation |
| Vessel tortuosity as assessed by NIRFLI | 12 months after radiation |
| Vessel tortuosity as assessed by NIRFLI | 24 months after radiation |
| Vessel dilation ratio as assessed by NIRFLI | immediately before surgery |
| Vessel dilation ratio as assessed by NIRFLI | immediately before radiation (which is 6-8 weeks after surgery) |
| Vessel dilation ratio as assessed by NIRFLI | 6 months after radiation |
| Vessel dilation ratio as assessed by NIRFLI | 12 months after radiation |
| Vessel dilation ratio as assessed by NIRFLI | 24 months after radiation |
| Chemokine levels as assessed by bead assay |
| 6 months after radiation |
| Chemokine levels as assessed by bead assay | 12 months after radiation |
| Chemokine levels as assessed by bead assay | 24 months after radiation |
| Cytokine levels as assessed by bead assay | immediately before surgery |
| Cytokine levels as assessed by bead assay | immediately before radiation (which is 6-8 weeks after surgery) |
| Cytokine levels as assessed by bead assay | 6 months after radiation |
| Cytokine levels as assessed by bead assay | 12 months after radiation |
| Cytokine levels as assessed by bead assay | 24 months after radiation |
| Number of participants with autoimmune antibodies as assessed by ELISA | immediately before surgery |
| Number of participants with autoimmune antibodies as assessed by ELISA | immediately before radiation (which is 6-8 weeks after surgery) |
| Number of participants with autoimmune antibodies as assessed by ELISA | 6 months after radiation |
| Number of participants with autoimmune antibodies as assessed by ELISA | 12 months after radiation |
| Number of participants with autoimmune antibodies as assessed by ELISA | 24 months after radiation |