NCT04701645

Microdevice In Ovarian, Fallopian Tube, And Peritoneal Cancer

Pilot Study of an Implantable Microdevice for Evaluating Drug Responses in Situ in Ovarian, Fallopian Tube, and Peritoneal Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot 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. The name of the study intervention involved in this study is: -implantable microdevice

Detailed 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 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.

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Peritoneal Cancer
• Ovarian Cancer Stage III
• Ovarian Cancer Stage IV
• Fallopian Tube Cancer Stage IV
• Fallopian Tube Cancer Stage III

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Microdevice	Placement of 1 to 6 implantable microdevices with multiple miniature drug reservoirs into a tumor mass 24 +/- 8 hours prior to surgery. Drugs will be released over 24 (+/- 8) hours while the microdevice is in the tumor prior to retrieval. The local tissue is retrieved along with the microdevice and no residual drug will remain. * Each microdevice will harbor up to 20 drugs and drug combinations relevant to the treatment of ovarian cancer. * Each drug or drug combination will be released from a single, separate reservoir. At least two reservoirs will harbor a drug vehicle only. * Drugs will include all or a subset of the following: Cisplatin, Carboplatin, Paclitaxel, Doxorubicin or pegylated liposomal doxorubicin (PLD), Cyclophosphamide, Etoposide, Gemcitabine, Ifosfamide, Pemetrexed, Topotecan, Vinorelbine, Olaparib, Niraparib, Rucaparib, Carboplatin + paclitaxel (combination), Carboplatin + doxorubicin (combination),Carboplatin + gemcitabine (combination)

Timeline

• Start date: 2022-11-01
• Primary completion: 2026-06-05
• Completion: 2026-06-30
• First posted: 2021-01-08
• Last updated: 2025-02-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study