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Microdevice for Ovarian Cancer

Phase 1
Recruiting
Led By Elizabeth Stover, MD, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be evaluated by a surgical gynecologic oncologist who will determine the clinically appropriate treatment strategy 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.
Patients must have the ability to understand and the willingness to sign a written informed consent document.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is being conducted to assess the feasibility of using this device to measure local intratumor response to chemotherapy and other clinically relevant drugs in ovarian, fallopian tube, and primary peritoneal cancer.

Who is the study for?
This trial is for adults with advanced stage (III-IV) ovarian, fallopian tube, or peritoneal cancer. Candidates must be medically stable for procedures and willing to undergo genetic sequencing. They need a negative pregnancy test if of childbearing potential and cannot have uncontrolled illnesses or conditions that increase biopsy/surgery risks.Check my eligibility
What is being tested?
The study tests an implantable microdevice's ability to measure the local tumor response to chemotherapy in patients with certain types of cancer. It aims to determine the feasibility of this technology in guiding personalized treatment strategies.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include complications from surgical procedures such as infection, bleeding, or reactions related to additional imaging required by the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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A specialist has confirmed I'm fit for surgery and biopsy for my condition.
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I can understand and am willing to sign the consent form.
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I agree to have my genes tested and shared anonymously for research.
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Your blood counts need to be within a certain range, and women who can have children must have a negative pregnancy test. If you're in cohort 4, you need to have these tests within 7 days before the microdevice placement.
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I've had a CT scan of my abdomen/pelvis within the last 4 weeks to check for a safe spot for a device placement.
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My doctors agree I'm stable enough for surgery and other procedures.
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I have advanced ovarian, fallopian tube, or peritoneal cancer.
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I am 18 years old or older.
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My disease has enough tissue for diagnosis even after removing the lesion for the microdevice.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of implanted microdevices successfully retrieved
Number of participants with adverse events as defined in the CTCAE v5.0
Other outcome measures
Compare extent of tumor response to drug among multiple microdevices implanted within a single tumor
Correlate extent of tumor response with exploratory biomarkers of drug response
Correlate extent of tumor response with genetic features of the tumor tissue
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4: Interval debulking surgery following neoadjuvant chemotherapyExperimental Treatment1 Intervention
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 will undergo percutaneous placement of several microdevices in a selected tumor deposit prior to surgery. The microdevices will dwell in the tumor tissue for approximately 24 +/- 8 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Microdevices will then be removed by resection of the tumor mass during a previously planned, and clinically indicated, surgical procedure.
Group II: Cohort 3: Secondary cytoreductionExperimental Treatment1 Intervention
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. Participants will undergo percutaneous placement of several microdevices in a selected tumor deposit prior to surgery. The microdevices will dwell in the tumor tissue for approximately 24 +/- 8 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Microdevices will then be removed by resection of the tumor mass during a previously planned, and clinically indicated, surgical procedure.
Group III: Cohort 2: Surgical assessment for primary surgeryExperimental Treatment1 Intervention
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. Participants will undergo percutaneous placement of several microdevices in a selected tumor deposit prior to surgery. The microdevices will dwell in the tumor tissue for approximately 24 +/- 8 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Microdevices will then be removed by resection of the tumor mass during a previously planned, and clinically indicated, surgical procedure.
Group IV: Cohort 1: Primary cytoreductionExperimental Treatment1 Intervention
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. Participants will undergo percutaneous placement of several microdevices in a selected tumor deposit prior to surgery. The microdevices will dwell in the tumor tissue for approximately 24 +/- 8 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Microdevices will then be removed by resection of the tumor mass during a previously planned, and clinically indicated, surgical procedure.

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,853 Total Patients Enrolled
39 Trials studying Ovarian Cancer
4,510 Patients Enrolled for Ovarian Cancer
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,327 Total Patients Enrolled
285 Trials studying Ovarian Cancer
73,688 Patients Enrolled for Ovarian Cancer
Elizabeth Stover, MD, PhDPrincipal Investigator - Dana-Farber Cancer Institute
Dana-Farber Cancer Institute

Media Library

Implantable Microdevice (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04701645 — Phase 1
Ovarian Cancer Research Study Groups: Cohort 2: Surgical assessment for primary surgery, Cohort 4: Interval debulking surgery following neoadjuvant chemotherapy, Cohort 1: Primary cytoreduction, Cohort 3: Secondary cytoreduction
Ovarian Cancer Clinical Trial 2023: Implantable Microdevice Highlights & Side Effects. Trial Name: NCT04701645 — Phase 1
Implantable Microdevice (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04701645 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the count of participants who have opted in to this research?

"Affirmative, according to clinicaltrials.gov's records this scientific trial is actively recruiting participants. The research was initially posted on November 1st 2022 and recently updated on the same day; it requires 20 individuals from 2 medical centres to participate in the study."

Answered by AI

Could you elaborate on the potential risks associated with Microdevice technology?

"Our experts noted that there is limited safety data and efficacy evidence associated with microdevice, thus assigning it a score of 1."

Answered by AI

Are there open slots for participants in this clinical experiment?

"Clinicaltrials.gov reports that this experiment is presently in the process of recruiting participants, with an initial post date on November 1st 2022 and a recent update on the same day."

Answered by AI
~2 spots leftby Jun 2024