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Microdevice for Ovarian Cancer

Q: 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.

Q: 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.

Q: 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.

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

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.

Patients must have absolute neutrophil count ≥ 1,500/mcL, Platelets ≥ 75,000/mcL, PT (INR) < 1.5, PTT < 1.5x control, and 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.

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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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.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,080 Previous Clinical Trials

340,917 Total Patients Enrolled

39 Trials studying Ovarian Cancer

4,502 Patients Enrolled for Ovarian Cancer

National Cancer Institute (NCI)NIH

13,704 Previous Clinical Trials

40,931,430 Total Patients Enrolled

287 Trials studying Ovarian Cancer

73,631 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 4: Interval debulking surgery following neoadjuvant chemotherapy, Cohort 2: Surgical assessment for primary surgery, 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

Recent research and studies

clinicaltrials.govStudy

Microdevice In Ovarian, Fallopian Tube, And Peritoneal Cancer

Elizabeth Stover, MD, PhD 2022. "Microdevice In Ovarian, Fallopian Tube, And Peritoneal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04701645.

All > Peritoneal Carcinomatosis