Using a microdevice to measure tumor response in ovarian and related cancers
Official title: Pilot Study of an Implantable Microdevice for Evaluating Drug Responses in Situ in Ovarian, Fallopian Tube, and Peritoneal Cancer
Run by Brigham and Women's Hospital · NCT04701645 · Data updated 2026-11-12
This study is testing a tiny device that will be placed in tumors of patients with advanced ovarian and related cancers to see how well different chemotherapy drugs work before surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 20 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Status | Recruiting |
| Started | November 1, 2022 |
| Main results expected | June 5, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | May 18, 2026 |
| Trial ID | NCT04701645 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with suspected or confirmed advanced-stage (III-IV) ovarian, fallopian tube, or peritoneal cancer who are surgical candidates.
✕Probably not a fit
Patients with early-stage cancer or those not eligible for surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study aims to evaluate the feasibility of an implantable microdevice that measures the local intratumor response to chemotherapy and other relevant drugs in patients with ovarian, fallopian tube, and primary peritoneal cancer. Participants with suspected or confirmed advanced-stage cancer will have the microdevice placed in their tumor tissue prior to surgery, allowing for assessment of drug effects over a short period. The microdevices will be removed during the surgical procedure, and the study will involve approximately 20 participants. This is the first investigation of this microdevice's application in identifying optimal cancer treatments.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment strategies for patients with advanced ovarian and related cancers.
How similar studies have gone: While this specific approach is novel, similar studies utilizing implantable devices for drug response measurement have shown promise in other cancer types.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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.
CT scans performed at outside institutions are acceptable providing that the images are considered adequate to assess the stage of the disease and to assess the safety and feasibility of the placement of the microdevices and their retrieval during standard-of care surgery. CT scan must be completed within 4 weeks prior to the microdevice placement.
* 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 Criteria:
* 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.)
Where it's running
-
Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting -
Dana Farber Cancer Institute
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Elizabeth Stover, MD, PhD — Dana-Farber Cancer Institute
- Study coordinator: Elizabeth Stover, MD, PhD
- Email: ehstover@partners.org
- Phone: (617) 632-5269
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using blood volume management during surgery for ovarian cancer patients
This study tests if a blood management technique called acute normovolemic hemodilution can help women with advanced ovarian cancer during surgery by reducing the need for blood transfusions and improving safety.
-
Raludotatug Deruxtecan With or Without Bevacizumab as First‑Line Maintenance in Advanced Ovarian Cancer
This trial tests whether maintenance therapy with raludotatug deruxtecan, with or without bevacizumab, helps people with advanced ovarian, fallopian tube, or primary peritoneal cancer live longer without the cancer growing after initial treatment.
-
Raludotatug Deruxtecan with or without Bevacizumab for advanced ovarian, peritoneal, or fallopian tube cancer
This trial tests whether adding raludotatug deruxtecan (R-DXd) to or without bevacizumab helps people with advanced ovarian cancer that progressed after PARP-inhibitor maintenance.
-
Personalized timing of interval debulking surgery for advanced ovarian, fallopian tube, and peritoneal cancer.
This study will see if using the CA125 drop rate (KELIM) to decide when to do interval debulking surgery helps people with advanced ovarian, fallopian tube, or peritoneal cancer who are receiving neoadjuvant chemotherapy.
-
Fluzoparib with or without Bevacizumab for treating advanced ovarian cancer
This study is testing whether a new drug called Fluzoparib, alone or with another drug called Bevacizumab, can help people with advanced ovarian cancer caused by BRCA1/2 mutations do better than standard chemotherapy.
-
Using tart cherry juice to prevent nerve damage from chemotherapy in breast cancer patients
This study is testing if drinking tart cherry juice can help prevent nerve damage in breast cancer patients receiving chemotherapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.