Microdevice In Ovarian, Fallopian Tube, And Peritoneal Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Fallopian Tube Cancer
- Fallopian Tube Cancer Stage III
- Fallopian Tube Cancer Stage IV
- Ovarian Cancer
- Ovarian Cancer Stage III
- Ovarian Cancer Stage IV
- Peritoneal Cancer
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
This research study will assess the feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in ovarian, fallopian tube, and primary peritoneal cancer. Participants with suspected or confirmed ovarian cancer whose treatm...
This research study will assess the feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in ovarian, fallopian tube, and primary peritoneal cancer. Participants with suspected or confirmed ovarian cancer whose treatment plan includes surgery as a component of standard-of-care treatment will be identified. -The research study procedures include screening for eligibility and study treatment including evaluations and follow-up. The name of the study intervention involved in this study is: implantable microdevice Participant will undergo percutaneous placement of several microdevices in a selected tumor deposit prior to surgery. The microdevices will dwell in the tumor tissue for approximately 24 +/- 8 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Microdevices will then be removed by resection of the tumor mass during a previously planned, and clinically indicated, surgical procedure. It is expected that about 20 people will take part in this research study. This research study is a Pilot Study, which is the first time investigators are examining this microdevice. The FDA (the U.S. Food and Drug Administration) has not approved the microdevice as a tool to identify which cancer treatment is best for any disease.
Tracking Information
- NCT #
- NCT04701645
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Elizabeth Stover, MD, PhD Dana-Farber Cancer Institute