Pilot study of an implantable microdevice for evaluating drug responses in situ in ovarian, fallopian tube, and peritoneal cancer

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

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.)