Trial Outcomes & Findings for Intraoperative Detection of Lesions Using PET (Positron Emission Tomography) Probe During Secondary Cytoreductive Surgery for Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer (NCT NCT01826227)
NCT ID: NCT01826227
Last Updated: 2017-11-06
Results Overview
of detection of lesions with PET probes compared to preoperative FDG18F-FDG PET and standard intraoperative examination. Sensitivity is defined as the percent of lesions that were found with malignant disease divided by the number of lesions with true presence of malignant disease based on the pathology report. A higher sensitivity will indicate a higher number of lesions found with the respective technique thus providing an initial estimate of the incremental benefit of the PET probe as opposed to the other techniques
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
2 years
Results posted on
2017-11-06
Participant Flow
Participant milestones
| Measure |
Positron Emission Tomography
This is a pilot study to determine the ability of intraoperative PET probe to detect and localize recurrent disease. Patients with evidence for a first recurrence of ovarian, fallopian tube or primary peritoneal carcinoma, with evidence of 18F-FDG avid disease on 18F-FDG PET/CT and who are able to undergo secondary CRS are eligible. 20 patients will be studied. All patients will undergo secondary cytoreduction guided by intraoperative PET probe survey. Intraoperative count levels as well as exvivo counts of the resected specimens will be done. Specimens detected with probe only will be labeled so and will be submitted to pathology for histopathologic confirmation.
Positron Emission Tomography
18F-Fluoro-2-deoxy-D-lucose
Cytoreductive surgery
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intraoperative Detection of Lesions Using PET (Positron Emission Tomography) Probe During Secondary Cytoreductive Surgery for Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Positron Emission Tomography
n=5 Participants
This is a pilot study to determine the ability of intraoperative PET probe to detect and localize recurrent disease. Patients with evidence for a first recurrence of ovarian, fallopian tube or primary peritoneal carcinoma, with evidence of 18F-FDG avid disease on 18F-FDG PET/CT and who are able to undergo secondary CRS are eligible. 20 patients will be studied. All patients will undergo secondary cytoreduction guided by intraoperative PET probe survey. Intraoperative count levels as well as exvivo counts of the resected specimens will be done. Specimens detected with probe only will be labeled so and will be submitted to pathology for histopathologic confirmation.
Positron Emission Tomography
18F-Fluoro-2-deoxy-D-lucose
Cytoreductive surgery
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Data not available because the PET probe failed.
of detection of lesions with PET probes compared to preoperative FDG18F-FDG PET and standard intraoperative examination. Sensitivity is defined as the percent of lesions that were found with malignant disease divided by the number of lesions with true presence of malignant disease based on the pathology report. A higher sensitivity will indicate a higher number of lesions found with the respective technique thus providing an initial estimate of the incremental benefit of the PET probe as opposed to the other techniques
Outcome measures
| Measure |
Positron Emission Tomography
n=5 Participants
This is a pilot study to determine the ability of intraoperative PET probe to detect and localize recurrent disease. Patients with evidence for a first recurrence of ovarian, fallopian tube or primary peritoneal carcinoma, with evidence of 18F-FDG avid disease on 18F-FDG PET/CT and who are able to undergo secondary CRS are eligible. 20 patients will be studied. All patients will undergo secondary cytoreduction guided by intraoperative PET probe survey. Intraoperative count levels as well as exvivo counts of the resected specimens will be done. Specimens detected with probe only will be labeled so and will be submitted to pathology for histopathologic confirmation.
Positron Emission Tomography
18F-Fluoro-2-deoxy-D-lucose
Cytoreductive surgery
|
|---|---|
|
Sensitivity
|
NA Participants
Data not available because the PET probe failed.
|
Adverse Events
Positron Emission Tomography
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Positron Emission Tomography
n=5 participants at risk
This is a pilot study to determine the ability of intraoperative PET probe to detect and localize recurrent disease. Patients with evidence for a first recurrence of ovarian, fallopian tube or primary peritoneal carcinoma, with evidence of 18F-FDG avid disease on 18F-FDG PET/CT and who are able to undergo secondary CRS are eligible. 20 patients will be studied. All patients will undergo secondary cytoreduction guided by intraoperative PET probe survey. Intraoperative count levels as well as exvivo counts of the resected specimens will be done. Specimens detected with probe only will be labeled so and will be submitted to pathology for histopathologic confirmation.
Positron Emission Tomography
18F-Fluoro-2-deoxy-D-lucose
Cytoreductive surgery
|
|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
20.0%
1/5 • 1 year
|
Other adverse events
| Measure |
Positron Emission Tomography
n=5 participants at risk
This is a pilot study to determine the ability of intraoperative PET probe to detect and localize recurrent disease. Patients with evidence for a first recurrence of ovarian, fallopian tube or primary peritoneal carcinoma, with evidence of 18F-FDG avid disease on 18F-FDG PET/CT and who are able to undergo secondary CRS are eligible. 20 patients will be studied. All patients will undergo secondary cytoreduction guided by intraoperative PET probe survey. Intraoperative count levels as well as exvivo counts of the resected specimens will be done. Specimens detected with probe only will be labeled so and will be submitted to pathology for histopathologic confirmation.
Positron Emission Tomography
18F-Fluoro-2-deoxy-D-lucose
Cytoreductive surgery
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
5/5 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
5/5 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
5/5 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
100.0%
5/5 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
60.0%
3/5 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
60.0%
3/5 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
60.0%
3/5 • 1 year
|
|
Investigations
Blood bilirubin increased
|
40.0%
2/5 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
40.0%
2/5 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
40.0%
2/5 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
40.0%
2/5 • 1 year
|
|
Investigations
Platelet count decreased
|
40.0%
2/5 • 1 year
|
|
Investigations
Activated partial thromboplastin time prolonged
|
20.0%
1/5 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.0%
1/5 • 1 year
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
20.0%
1/5 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
20.0%
1/5 • 1 year
|
|
Investigations
INR increased
|
20.0%
1/5 • 1 year
|
|
Investigations
White blood cell decreased
|
20.0%
1/5 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place