An interventional study of Positron Emission Tomography and 18F-Fluoro-2-deoxy-D-lucose in Ovarian Cancer, Fallopian Tube and Primary Peritoneal, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2017-11-06.
Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Diagnostic
The purpose of this study is to see if Positron Emission Tomography (PET) probes make it easier for your surgeon to find cancer and remove it during your surgery. A PET probe is a wandlike device that can detect radioactivity.
Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Positron Emission Tomography · Radiation: 18F-Fluoro-2-deoxy-D-lucose · Procedure: Cytoreductive surgery
Sensitivity
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
Time frame: 2 years
| Milestone | Positron Emission Tomography |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
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
| Participants | Positron Emission Tomography |
|---|---|
| Sensitivity | NA |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Positron Emission Tomography | 0/5 (0%) | 1/5 (20%) | 5/5 (100%) |
| Event | Positron Emission Tomography |
|---|---|
| Supraventricular tachycardiaCardiac disorders | 1/5 |
| Event | Positron Emission Tomography |
|---|---|
| AnemiaBlood and lymphatic system disorders | 5/5 |
| HyperglycemiaMetabolism and nutrition disorders | 5/5 |
| HypoalbuminemiaMetabolism and nutrition disorders | 5/5 |
| HypocalcemiaMetabolism and nutrition disorders | 5/5 |
| Alanine aminotransferase increasedInvestigations | 3/5 |
| Aspartate aminotransferase increasedInvestigations | 3/5 |
| HypophosphatemiaMetabolism and nutrition disorders | 3/5 |
| Blood bilirubin increasedInvestigations | 2/5 |
| HypomagnesemiaMetabolism and nutrition disorders | 2/5 |
| HyponatremiaMetabolism and nutrition disorders | 2/5 |
| Age, Continuous(years) | Positron Emission Tomography |
|---|---|
| Median | 62 (44 to 69) |
| Sex: Female, Male(Participants) | Positron Emission Tomography |
|---|---|
| Female | 5 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Positron Emission Tomography |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 5 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Positron Emission Tomography |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Positron Emission Tomography |
|---|---|
| United States | 5 |
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Memorial Sloan Kettering Cancer Center