Ovarian Cancer
Conditions
Keywords
Ovarian Cancer
Brief summary
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.
Interventions
DRUGEC-17
One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Women who are: * Diagnosed with or at high clinical suspicion of primary ovarian cancer by either radiologic imaging or physical examination or biopsy or serum tumor markers * Scheduled to undergo surgical cytoreduction via laparotomy * At least 18 years of age * Capable and willing to provide informed consent
Exclusion criteria
Women with: * Known sarcomatous histologies * Recurrent ovarian cancer * Planned surgical approach via laparoscopy or robotic surgery * A history of anaphylactic reactions to Folate-FITC or insects * Inability or unwillingness to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity of Intra-operative Imaging Using Folate-FITC for Identification of Ovarian Cancer Metastatic to the Peritoneum and Lymph Nodes | 1 week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Grade 4 or Higher Adverse Events Following a One-time Dose of Folate-FITC (EC-17). | Duration of hospitalization with a maximum of 7 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Folate-FITC EC-17: One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery. | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Folate-FITC |
|---|---|
| Age, Customized Age 40-49 | 3 Participants |
| Age, Customized Age 50-59 | 6 Participants |
| Age, Customized Age 60-69 | 9 Participants |
| Age, Customized Age 70-79 | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 15 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
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.
Time frame: 1 week
Population: 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.
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.
Time frame: Duration of hospitalization with a maximum of 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Folate-FITC | Number of Participants With Grade 4 or Higher Adverse Events Following a One-time Dose of Folate-FITC (EC-17). | 0 Participants |