N/A
Completed 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
Source: ClinicalTrials.gov NCT01826227 ↗
Enrolled (actual)
5
Serious AEs
20.0%
Results posted
Nov 2017
Primary outcomePrimary: Sensitivity — NA Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity |
NA | — |
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. Informational only — not medical advice.