Microdevice for Ovarian Cancer

Recruiting at 1 trial location

Overseen By Madeline Polak, BS

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Brigham and Women's Hospital

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Uncontrolled illness, Bleeding disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anticoagulation medication (blood thinners), you may need to stop them unless you are only taking low-dose aspirin.

What data supports the effectiveness of this treatment for ovarian cancer?

The research shows that using a microdevice to deliver chemotherapy directly to ovarian cancer tumors in mice resulted in similar tumor reduction with less toxicity compared to traditional methods. Additionally, a microdevice used for drug sensitivity screening in ovarian cancer models accurately predicted treatment outcomes, suggesting potential effectiveness in guiding therapy decisions. ^{1 2 3 4 5}

Is the implantable microdevice safe for use in humans?

Research on an implantable microdevice for delivering chemotherapy in ovarian cancer mouse models showed it caused less toxicity compared to traditional methods, suggesting it may be safer. Additionally, a study on a similar device in lung cancer patients found it safe for implantation and retrieval, indicating general safety in humans. ^{1 2 4 5 6}

How is the Implantable Microdevice treatment for ovarian cancer different from other treatments?

The Implantable Microdevice treatment for ovarian cancer is unique because it uses a small device implanted in the body to test multiple cancer drugs simultaneously, allowing for personalized treatment plans. This approach is different from traditional treatments that typically involve systemic chemotherapy without such individualized testing. ^{1 5 6 7 8}

What is the purpose of this trial?

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

Research Team

Elizabeth Stover, MD, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

Participants must meet one of the following clinical categories: Cohort 1, Cohort 2, Cohort 3, Cohort 4 as specified in the detailed text.

The patient's CT scan shows that there is enough disease for the microdevice to be implanted.

You need to have a lab test done within 14 days before the microdevice is placed.

Exclusion Criteria

I cannot safely stop my blood thinner medication, except for low-dose aspirin.

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.

I have a bleeding or clotting disorder that makes surgery risky.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Microdevice Placement and Evaluation

Participants undergo percutaneous placement of microdevices in tumor tissue, which dwell for approximately 24 +/- 8 hours to measure local intratumor response to drugs.

1 week

1 visit (in-person)

Surgical Procedure

Microdevices are removed by resection of the tumor mass during a planned surgical procedure.

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and progression-free survival.

Up to 3 years

Treatment Details

Interventions

• Implantable Microdevice

Trial Overview 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.

Participant Groups

Group I: Cohort 4: Interval debulking surgery following neoadjuvant chemotherapy Experimental Treatment 1 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 cytoreduction Experimental Treatment 1 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 surgery Experimental Treatment 1 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 cytoreduction Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The programmable bio-nano-chip (p-BNC) platform can effectively quantify a multi-marker panel for ovarian cancer detection, showing 68.7% sensitivity and 80% specificity in a study of 31 patients, which included both early- and late-stage cancers.

The p-BNC offers advantages for point-of-care diagnostics, including rapid analysis time of 43 minutes, low limits of detection, and minimal day-to-day variability (5.4% to 10.5%), making it a promising tool for large-scale screening and longitudinal monitoring of ovarian cancer biomarkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multiplexable, microfluidic platform for the rapid quantitation of a biomarker panel for early ovarian cancer detection at the point-of-care. Shadfan, BH., Simmons, AR., Simmons, GW., et al.[2019]

The study demonstrated that a novel implantable microdevice (IMD) can be safely implanted and retrieved in patients with non-small cell lung cancer (NSCLC) during surgery, with a 93% retrieval success rate and no severe adverse reactions reported.

The IMD allows for localized delivery of multiple chemotherapeutic agents, showing differential tumor responses to the drugs, which could help tailor personalized treatment regimens based on individual tumor characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-Human Intrathoracic Implantation of Multidrug-Eluting Microdevices for In Situ Chemotherapeutic Sensitivity Testing as Proof of Concept in Nonsmall Cell Lung Cancer. Tsai, LL., Phillips, WW., Hung, YP., et al.[2023]

A new drug sensitivity screening assay using a microdevice can predict treatment outcomes for patients with high-grade ovarian cancer in a clinically relevant timeframe, significantly reducing the number of animals needed for testing (from 206 to 10).

The assay demonstrated a high predictive accuracy (average AUC of 0.91) for treatment outcomes against three second-line therapies, indicating its potential utility in guiding personalized treatment decisions for ovarian cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Machine-learning aided in situ drug sensitivity screening predicts treatment outcomes in ovarian PDX tumors. Cotler, MJ., Ramadi, KB., Hou, X., et al.[2022]

Intraperitoneal (IP) chemotherapy using an implantable microdevice for ovarian cancer can prolong survival by delivering a constant dose of medication, achieving similar tumor reduction as traditional weekly IP bolus injections.

The microdevice resulted in significantly less toxicity compared to bolus injections, even with higher total drug doses, suggesting a safer and more effective method for administering chemotherapy in ovarian cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained, low-dose intraperitoneal cisplatin improves treatment outcome in ovarian cancer mouse models. Ye, H., Tanenbaum, LM., Na, YJ., et al.[2017]

The programmable bio-nano-chip (p-BNC) offers a rapid and sensitive method for quantifying the CA125 biomarker in ovarian cancer, achieving results in under 45 minutes with high precision.

Validation with patient sera demonstrated an excellent correlation with traditional ELISA tests, indicating that the p-BNC could be a reliable point-of-care diagnostic tool for early detection of ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmable bio-nano-chip systems for serum CA125 quantification: toward ovarian cancer diagnostics at the point-of-care. Raamanathan, A., Simmons, GW., Christodoulides, N., et al.[2021]

A novel microfluidic detection platform was developed to simultaneously measure multiple biomarkers for early detection of ovarian cancer, achieving an ultra-sensitive detection limit of approximately 1 pg/mL.

In a study involving 18 ovarian cancer patients and 4 healthy individuals, the platform effectively distinguished between different types of ovarian tumors and healthy subjects, indicating its potential for early cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A high-performance microfluidic detection platform to conduct a novel multiple-biomarker panel for ovarian cancer screening. Wu, Y., Wang, C., Wang, P., et al.[2022]

The study developed a microfluidic platform that effectively isolates and quantifies the ovarian cancer biomarker miRNA-21 from blood, which is crucial for early detection of ovarian cancer.

The platform demonstrated a high sensitivity with a limit of detection of 11 copies per mL and an accuracy of less than 12%, indicating its potential as a reliable tool for measuring ovarian cancer biomarkers in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isolation and quantification of extracellular vesicle-encapsulated microRNA on an integrated microfluidic platform. Sung, CY., Huang, CC., Chen, YS., et al.[2021]

A new microchip ELISA-based detection system using a cell phone or CCD can effectively measure the ovarian cancer biomarker HE4 in urine, providing a simple and cost-effective method for early detection.

This system demonstrated high sensitivity (89.5%) and specificity (90%) for detecting ovarian cancer in urine samples, indicating its potential for point-of-care diagnostics and improving early detection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integration of cell phone imaging with microchip ELISA to detect ovarian cancer HE4 biomarker in urine at the point-of-care. Wang, S., Zhao, X., Khimji, I., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

A multiplexable, microfluidic platform for the rapid quantitation of a biomarker panel for early ovarian cancer detection at the point-of-care. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

First-in-Human Intrathoracic Implantation of Multidrug-Eluting Microdevices for In Situ Chemotherapeutic Sensitivity Testing as Proof of Concept in Nonsmall Cell Lung Cancer. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Machine-learning aided in situ drug sensitivity screening predicts treatment outcomes in ovarian PDX tumors. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Sustained, low-dose intraperitoneal cisplatin improves treatment outcome in ovarian cancer mouse models. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Programmable bio-nano-chip systems for serum CA125 quantification: toward ovarian cancer diagnostics at the point-of-care. [2021]

6. England pubmed.ncbi.nlm.nih.gov

A high-performance microfluidic detection platform to conduct a novel multiple-biomarker panel for ovarian cancer screening. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Isolation and quantification of extracellular vesicle-encapsulated microRNA on an integrated microfluidic platform. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Integration of cell phone imaging with microchip ELISA to detect ovarian cancer HE4 biomarker in urine at the point-of-care. [2021]