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Intraoperative Detection of Lesions Using PET (Positron Emission Tomography) Probe During Secondary Cytoreductive Surgery for Recurrent Ovarian Cancer: A Pilot Study


N/A
19 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

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Trial Information

Intraoperative Detection of Lesions Using PET (Positron Emission Tomography) Probe During Secondary Cytoreductive Surgery for Recurrent Ovarian Cancer: A Pilot Study


Inclusion Criteria:



- Pathologically proven diagnosis of ovarian carcinoma 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

sensitivity and specificity

Outcome Description:

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 Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Dennis Chi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

13-017

NCT ID:

NCT01826227

Start Date:

March 2013

Completion Date:

March 2015

Related Keywords:

  • Ovarian Cancer
  • PET (Positron Emission Tomography)
  • 18F-FDG
  • Cytoreductive Surgery
  • 13-017
  • Ovarian Neoplasms

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021