Microdevice In Ovarian, Fallopian Tube, And Peritoneal Cancer
NCT04701645 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-05-18
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
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
- 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)
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - collaborator OTHER
-
Brigham and Women's Hospital
lead OTHER
Principal Investigators
-
Elizabeth Stover, MD, PhD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-01
- Primary Completion
- 2027-06-05
- Completion
- 2027-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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