Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators hypothesis is that if sensitivity and specificity are found to be significantly higher than the current reports with Technesium-99 and ISB colorimetric dye, SLN biopsies might allow omission of full lymphadenectomy in lower-risk cases, thereby limiting peri-operative morbidity. SLN biopsies might also improve the detection of metastatic disease, essentially lowering the recognized false-negative rate of standard lymphadenectomy analyzed by routine H&E pathologic analysis.
The study objective is to compare two sentinel lymph node detection technologies [fluorescence imaging and Indocyanine Green (ICG) dye verses standard laparoscopic colorimetric analysis using Isosulfan Blue (ISB) dye] for sensitivity and specificity of detecting metastatic disease in pelvic lymph nodes of women with endometrial cancer undergoing robotic-assisted laparoscopic hysterectomy and lymphadenectomy. The following three specific aims would be addressed in this research proposal:
Specific Aim 1: To determine the ability of mapping bilaterally pelvic SLN in women with endometrial cancer undergoing robotic-assisted laparoscopic staging comparing two different methods (i.e., comparing the combination of colorimetric analysis-ISB dye + fluorescence imaging-ICG dye vs. colorimetric analysis-ISB dye alone).
Specific Aim 2: To estimate the negative predictive value (NPV) of pelvic SLN in endometrial cancer with respect to predicting nodal metastasis.
Specific Aim 3: To evaluate the ability of sentinel lymph nodes to increase the detection of metastatic disease through ultra-sectioning and immuno-histochemical (IHC) staining by comparing IHC results and standard hematoxylin and eosin (H&E) results.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISB dye, standard white light | Active Comparator | SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging. |
|
| ICG dye, FireFly fluorescence imaging | Experimental | SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISB dye and standard white light imaging | Device | Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Pelvic Sentinel Lymph Nodes (SLN) in Endometrial Cancer Patients Detected by Either ICG and/or ISB Dyes. | through 6 weeks post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Negative Predictive Value (NPV) of Pelvic SLN in Endometrial Cancer in Relation to the Number of Nodes With Metastasis. | The standard definition for negative predictive value was used to calculate NPV. There was one false negative SLN in this study, 39 true positive sentinel lymph nodes, and 140 negative pelvic metastatic patients. NPV = 140/141=99.3% | through 6 weeks post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Pelvic Sentinal Lymph Nodal Metastasis in Regard to Staining by Immunohistochemical (IHC) Staining in Comparison to Standard Hematoxylin and Eosin (H&E). | Of the 127 positive nodes with pathology information, the percentage of each type of node will be summarized by the staining method. Statistical testing of the individual staining methods compared to both will be computed using Chi-square test of independence. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Holloway, MD | Florida Hospital Gynecologic Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Hospital Gynecologic Oncology | Orlando | Florida | 32804 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ISB Dye, Standard White Light | SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging. ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging. |
| FG001 | ICG Dye, FireFly Fluorescence Imaging | SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging. ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging. ICG dye and FireFly fluorescence imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ISB Dye, Standard White Light | SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging. ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Pelvic Sentinel Lymph Nodes (SLN) in Endometrial Cancer Patients Detected by Either ICG and/or ISB Dyes. | The ISB dye alone group (n=20) and the ICG group (n=180) are combined, because both groups received the ISB dye. | Posted | Mean | Standard Deviation | nodes | through 6 weeks post-operative |
|
Post-op follow up 6 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ISB Only Adverse Events | ISB only Adverse Events categories reported during post-op follow up 6 weeks |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reproductive system complications | Reproductive system and breast disorders | Systematic Assessment | The following were effected: Vaginal discharge Vasomotor symptoms Vaginal spotting Uterovaginal fistula Vaginal bleeding Pelvic abscess Vaginal leakage |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert W. Holloway | Florida Hospital Gynecologic Oncology | 407-303-2400 | robhollowaymd@gmail.com |
Not provided
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ICG dye and FireFly fluorescence imaging | Device | Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging. |
|
|
| through 6 weeks post-operative |
| ICG Dye, FireFly Fluorescence Imaging |
SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging. ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging. ICG dye and FireFly fluorescence imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Age | Median | Standard Deviation | years |
|
|
|
| Secondary | Negative Predictive Value (NPV) of Pelvic SLN in Endometrial Cancer in Relation to the Number of Nodes With Metastasis. | The standard definition for negative predictive value was used to calculate NPV. There was one false negative SLN in this study, 39 true positive sentinel lymph nodes, and 140 negative pelvic metastatic patients. NPV = 140/141=99.3% | Comparison of metastatic disease (yes or no) with ICG dye node detection (yes or no) | Posted | Count of Participants | Participants | through 6 weeks post-operative |
|
|
|
| Other Pre-specified | Number of Pelvic Sentinal Lymph Nodal Metastasis in Regard to Staining by Immunohistochemical (IHC) Staining in Comparison to Standard Hematoxylin and Eosin (H&E). | Of the 127 positive nodes with pathology information, the percentage of each type of node will be summarized by the staining method. Statistical testing of the individual staining methods compared to both will be computed using Chi-square test of independence. | These are positive sentinel lymph nodes | Posted | Number | nodes | through 6 weeks post-operative | Nodes | Nodes |
|
|
|
| 0 |
| 20 |
| 5 |
| 20 |
| EG001 | ICG Adverse Events | ICG Adverse Events categories reported during post-op follow up 6 weeks | 0 | 180 | 29 | 180 |
|
| Renal and urinary complications | Renal and urinary disorders | Systematic Assessment | The following were effected: Acute renal insufficiency Polyuria Transient right hydronephrosis Urinary retention |
|
| Wound complications | Surgical and medical procedures | Systematic Assessment | The following were effected: Wound dehiscence Wound seroma Left incisional drainage |
|
| Cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment | The following were effected: Cellulitis |
|
| Respiratory, thoracic, and pulmonary complications | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | The following were effected: Pulmonary embolism Pleural effusions Pneumothorax |
|
| Cardiac complications | Cardiac disorders | Systematic Assessment | The following were effected: Cardiac complications Tachycardia Atrial fibrillation |
|
| Vascular complications | Vascular disorders | Systematic Assessment | The following were effected: Deep Vein Thrombosis |
|
| Gastrointestinal complications | Gastrointestinal disorders | Systematic Assessment | The following were effected: Small bowel obstruction |
|
| General disorders and administration site conditions | General disorders | Systematic Assessment | The following were effected: Hypotension Hypertension Lymphedema Fever |
|
| Blood and lymphatic system complications | Blood and lymphatic system disorders | Systematic Assessment | The following were effected: Leukocytosis Anemia Thrombocytopenia Neutropenia Lymphatic ascites |
|
Not provided
Not provided
Not provided
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| Title | Measurements |
|---|---|
|
| Aortic |
|
| Infrarenal |
|