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RECRUITING
NCT04701645
PHASE1

Microdevice In Ovarian, Fallopian Tube, And Peritoneal Cancer

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2022-11-01

Completion Date

2026-06-30

Last Updated

2025-02-05

Healthy Volunteers

No

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)

Locations (2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States