N/A
N=5
Intraoperative Detection of Lesions Using PET (Positron Emission Tomography) Probe During Secondary Cytoreductive Surgery for Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer
Ovarian Cancer · Fallopian Tube · Primary Peritoneal
Bottom Line
View on ClinicalTrials.gov: NCT01826227 ↗Enrolled (actual)
5
Serious AEs
20.0%
Results posted
Nov 2017
Primary outcome: Primary: Sensitivity — NA Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Positron Emission Tomography (Procedure); 18F-Fluoro-2-deoxy-D-lucose (Radiation); Cytoreductive surgery (Procedure)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- Female
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity |
NA | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Pathologically proven diagnosis of ovarian carcinoma, fallopian tube, or primary peritoneal not to include tumors of low malignant potential (all stage, grade, and histology)
- First recurrence
- Platinum sensitive as defined by disease free interval ≥ 6 months
- Radiological evidence of recurrent disease on preoperative PET/diagnostic CT
- Planned surgical secondary cytoreduction via laparotomy
- >18 years old
Exclusion Criteria
- Secondary cytoreduction via laparoscopy or robotically assisted laparoscopy
- Tumors of low malignant potential
- Beyond first recurrence
- With the exception of non-melanoma skin cancer, subjects with other invasive malignancies, who had (or have) any evidence of the other cancer present within the last 5 years, are excluded
- Active infection requiring parenteral antibiotics
- For subjects with diabetes mellitus, a blood sugar will be checked preoperatively and must be <200 for participation in the study
Data sourced from ClinicalTrials.gov (NCT01826227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.