RECRUITING

Microdevice In Ovarian, Fallopian Tube, And Peritoneal Cancer

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 Implantable Microdevice

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-11-01

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04701645

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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.	* 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.)

Inclusion Criteria

Exclusion 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.
* 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.

* 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.)

Contacts and Locations

Study Contact

Elizabeth Stover, MD, PhD

CONTACT

(617) 632-5269

ehstover@partners.org

Madeline Polak, BS

CONTACT

madeline_polak@dfci.harvard.edu

Principal Investigator

Elizabeth Stover, MD, PhD

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-01

Study Completion Date2026-06

Study Record Updates

Study Start Date2022-11-01

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Implantable Microdevice
Ovarian Cancer Stage III
Ovarian Cancer Stage IV
Fallopian Tube Cancer Stage IV
Fallopian Tube Cancer Stage III

Additional Relevant MeSH Terms

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