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Pilot Study: Microdevice in Ovarian, Fallopian Tube, and Peritoneal Cancer

This pilot study is exploring a new way to understand how tumors respond to cancer drugs. If you have suspected or confirmed advanced ovarian, fallopian tube, or peritoneal cancer (cancer outside the pelvis) and are planning to have surgery, you might be able to participate. The study involves placing 1 to 6 small implantable microdevices into a tumor about 24 hours before your surgery. These microdevices have tiny drug reservoirs that release drugs into the tumor. During your planned surgery, the microdevices will be removed along with the tumor. Researchers will then check how many microdevices were successfully removed and track any side effects for up to two months. This study aims to see if this microdevice can help measure how tumors react to different treatments.

Study design
This is a pilot study, meaning it's the first time this microdevice is being tested. It plans to enroll about 20 women.
What's involved
You would undergo screening, have microdevices placed in a tumor before surgery, and then have them removed during your planned surgery. You will also have follow-up evaluations.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for up to two months after the microdevice placement.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04701645

Microdevice In Ovarian, Fallopian Tube, And Peritoneal Cancer

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
Brigham and Women's Hospital
~20 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:Microdevice

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events as defined in the CTCAE v5.0
Measured over Up to 2 months
+1 more outcome measured

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

Explore related trials

Fallopian Tube CarcinomaMalignant Ovarian NeoplasmMalignant Peritoneal Neoplasm

Where it's being run

2 sites across 1 states
Massachusetts2

Study leadership

  • Elizabeth Stover, MD, PhD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Elizabeth Stover, MD, PhD
[email protected]
(617) 632-5269
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants must have suspected or confirmed clinically advanced stage (III-IV, defined as disease outside of the pelvis) ovarian, fallopian tube, or peritoneal cancer. If a patient has suspected ovarian cancer but final histologic analysis does not show evidence of ovarian cancer, the patient will be removed from the study and replaced.
Participants must meet one of the following clinical categories:
Cohort 1: Patients with a new or suspected diagnosis of ovarian cancer who are deemed surgical candidates for primary cytoreductive surgery (as per their surgical gynecologic oncologist) and who have not yet undergone surgery.
Cohort 2: Patients with newly diagnosed ovarian cancers who are being considered for either primary surgery or neoadjuvant chemotherapy by their surgical gynecologic oncologist, and who require a laparoscopic procedure to determine their candidacy for surgery.
Cohort 3: Patients with recurrent ovarian cancer who are candidates for secondary cytoreduction, e.g. to confirm diagnosis of recurrent ovarian cancer and/or remove oligometastatic lesions.
Cohort 4: Patients with newly diagnosed ovarian cancers who have undergone neoadjuvant chemotherapy and are deemed surgical candidates for interval debulking surgery (as per their surgical gynecologic oncologist) and who have not yet undergone surgery.
Participants must be 18 years of age or older.
Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures by their treating gynecologic oncologist and medical oncologist.
Participants will undergo laboratory testing within 14 days\* prior to the microdevice placement.
Patients must have absolute neutrophil count ≥ 1,500/mcL
Platelets ≥ 75,000/mcL
PT (INR) \< 1.5
PTT \< 1.5x control
Women of childbearing potential must have negative pregnancy test (urine or serum) \*\*Cohort 4 patients should undergo laboratory testing within 7 days prior to the microdevice placement
Participants must be evaluated by a surgical gynecologic oncologist who will determine the clinically appropriate treatment strategy (primary surgery or neoadjuvant chemotherapy) based on clinical history and extent of disease. The patient's surgical and/or medical gynecologic oncologist must also confirm the patient's medical fitness to undergo an additional biopsy procedure and the indicated surgical procedure. The patient must have a plan to undergo surgery for clinical purposes.
The following criteria must be met:
Participants must have undergone an abdominal/pelvic CT scan that both assesses the extent of disease and identifies an area of tumor amenable to safe microdevice placement. CT scans with both oral and IV contrast media are preferred but not required.
Patient has sufficient volume of disease as measured by CT scan to allow implantation of the microdevice.
Patient has sufficient volume of disease that removal of the lesion where the microdevice is placed will not potentially affect adequate tissue for diagnosis.
A lesion can be selected where the microdevice is to be implanted that is
Amenable to percutaneous placement
Amenable to removal at the time of surgery or laparoscopy. If patient is undergoing laparoscopy, the lesion must be able to be removed using a laparoscopic approach in a manner that would not significantly alter the procedure or affect patient safety, per opinion of the surgical oncologist.
Patients must have the ability to understand and the willingness to sign a written informed consent document.
Patients must be willing to undergo research-related genetic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories.

Exclusion

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery.
Pregnant women are excluded from this study because of the possible increased dose of radiation from imaging associated with the microdevice placement and the potential risk to the pregnancy of the biopsy/device placement in an abdominal lesion.
Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or percutaneous biopsy procedures.
Significant risk factors (including, but not limited to, high risk of venous thrombosis, pulmonary embolism, stroke or myocardial infarction) precluding the safe cessation of anticoagulation medication as per SIR guidelines. (Patients taking low-dose aspirin only do not need to be excluded.)

What this trial measures

  • Number of participants with adverse events as defined in the CTCAE v5.0Up to 2 months

    Descriptive statistics will be used to evaluate the safety of microdevice placement and removal, including reporting the maximum grade AE by type and organ class with 95% binomial confidence intervals.

  • Number of implanted microdevices successfully retrievedUp to 32 hours

    Defined as the ability to retrieve the microdevice with sufficient tissue, of sufficient quality, for downstream histopathology analysis and interpretation of at least 50% of the microdevice reservoirs. For purposes of this endpoint, feasibility will be assessed on a per-device basis rather than a per-patient basis, with each microdevice considered to be relatively independent in terms of placement, retrieval, and analysis.