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Accrual temporarily suspended, followed by study closure due to technical problems with investigational camera.
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Prognosis for many carcinomas, including ovarian carcinoma, is dependent on a complete surgical resection, also known as a R0 resection. At present, the ability to perform a complete resection with negative margins is limited by the surgeon's ability to palpate and visualize the tumor and its margins. Therefore, in order to reduce operative morbidity and costs while maintaining or improving surgical and oncologic outcomes, the investigators must develop technologies that improve visualization of the primary tumor and occult metastases, real time, during surgery. Recent research has demonstrated that the use of fluorescent probes that recognize cancer specific antigens can be used for this purpose when visualized using a prototype near-infrared multispectral imaging system.
This investigation will determine if folate-FITC, a fluorescent probe that recognizes the folate receptor (present in > 90% of ovarian cancers) can facilitate surgical resection and detect tumor nodules not visible to the naked eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Folate-FITC | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EC-17 | Drug | One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of Intra-operative Imaging Using Folate-FITC for Identification of Ovarian Cancer Metastatic to the Peritoneum and Lymph Nodes | A maximum of 5 nodules less than 1cm in size will be identified in each patient with the naked eye and then visualized with the camera. The nodules will be biopsied after determining if they are fluorescent positive or negative (F+ or F-), and examined microscopically to confirm if carcinoma is present. Up to 5 F+ lesions that were not identified with the naked eye will also be biopsied and examined microscopically to determine if carcinoma is present. These data will establish the sensitivity and specificity of this technique using microscopic analysis as the gold standard. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 4 or Higher Adverse Events Following a One-time Dose of Folate-FITC (EC-17). | Study participants will be followed and all adverse events will be captured for the duration of hospitalization following administration of investigational product, up to a maximum of 7 days following IP administration and surgical procedure. Adverse Events will be classified as: grade 1=Mild, grade 2=Moderate, grade 3=Severe, grade 4=Life-threatening/disabling, grade 5 =Death. Significant is defined as adverse events grade 4 or higher. |
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Inclusion Criteria:
Women who are:
Exclusion Criteria:
Women with:
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| Name | Affiliation | Role |
|---|---|---|
| Sean C Dowdy, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Folate-FITC | EC-17: One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Folate-FITC | EC-17: One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Sensitivity and Specificity of Intra-operative Imaging Using Folate-FITC for Identification of Ovarian Cancer Metastatic to the Peritoneum and Lymph Nodes | A maximum of 5 nodules less than 1cm in size will be identified in each patient with the naked eye and then visualized with the camera. The nodules will be biopsied after determining if they are fluorescent positive or negative (F+ or F-), and examined microscopically to confirm if carcinoma is present. Up to 5 F+ lesions that were not identified with the naked eye will also be biopsied and examined microscopically to determine if carcinoma is present. These data will establish the sensitivity and specificity of this technique using microscopic analysis as the gold standard. | The investigational camera was instrumental for collecting data for this study. Due to technical problems with the camera from the onset of the study, the study was terminated and no data was able to be collected or analyzed. | Posted | 1 week |
|
Adverse events were collected from the period from the initiation of any study procedures to the end of the study treatment follow-up, approximately one week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Folate-FITC | EC-17: One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sneezing, spontaneous onset | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
The investigational camera was instrumental for collecting data for this study. Due to technical problems with the camera from the onset of the study, the study was terminated and no data was able to be collected or analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sean C. Dowdy, M.D. | Mayo Clinic | 507-266-0225 | Dowdy.Sean@mayo.edu |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| Duration of hospitalization with a maximum of 7 days |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
EC-17: One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery. |
|
| Secondary | Number of Participants With Grade 4 or Higher Adverse Events Following a One-time Dose of Folate-FITC (EC-17). | Study participants will be followed and all adverse events will be captured for the duration of hospitalization following administration of investigational product, up to a maximum of 7 days following IP administration and surgical procedure. Adverse Events will be classified as: grade 1=Mild, grade 2=Moderate, grade 3=Severe, grade 4=Life-threatening/disabling, grade 5 =Death. Significant is defined as adverse events grade 4 or higher. | Posted | Count of Participants | Participants | Duration of hospitalization with a maximum of 7 days |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 15 |
| 27 |
| Tingling sensation in mouth, palate and molars | Gastrointestinal disorders | Systematic Assessment |
|
| Mild facial flusing | Vascular disorders | Systematic Assessment |
|
| Sinus pressure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Plugged ears | Ear and labyrinth disorders | Systematic Assessment |
|
| Strong taste in mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Cirumoral and Nasal Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Migraine | Nervous system disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |