Actively Recruiting

Phase 1
Age: 18Years +
FEMALE
NCT04701645

Microdevice In Ovarian, Fallopian Tube, And Peritoneal Cancer

Led by Brigham and Women's Hospital · Updated on 2025-02-05

20

Participants Needed

2

Research Sites

191 weeks

Total Duration

On this page

Sponsors

B

Brigham and Women's Hospital

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Microdevice In Ovarian, Fallopian Tube, And Peritoneal Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must have suspected or confirmed advanced stage (III-IV) ovarian, fallopian tube, or peritoneal cancer.
  • Participants must fit into one of four clinical groups related to diagnosis and surgical candidacy.
  • Participants must be 18 years of age or older.
  • Participants must be medically stable to undergo percutaneous procedures and surgery.
  • Participants must have laboratory results within specified limits before microdevice placement.
  • Participants must be evaluated and approved by surgical and medical gynecologic oncologists.
  • Participants must have a recent CT scan showing disease extent and a suitable tumor for microdevice placement.
  • Participants must have sufficient tumor volume for implantation and safe removal during surgery.
  • Participants must understand and be willing to sign informed consent.
  • Participants must agree to research-related genetic sequencing and data sharing.
Not Eligible

You will not qualify if you...

  • Participants with uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting safety.
  • Pregnant women due to imaging radiation and biopsy risks.
  • Participants with uncorrectable bleeding or coagulation disorders increasing biopsy or surgery risk.
  • Participants with significant risk factors preventing safe cessation of anticoagulation medications, except those only taking low-dose aspirin.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

2

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

E

Elizabeth Stover, MD, PhD

CONTACT

M

Madeline Polak, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

4

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Microdevice In Ovarian, Fallopian Tube, And Peritoneal Cancer | DecenTrialz