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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a small implantable device to observe how ovarian, fallopian tube, and primary peritoneal cancers respond to various chemotherapy drugs. Researchers place the microdevice into a tumor to measure the tumor's reaction to the medication it releases. This could help doctors determine which treatments are most effective for each patient. The trial seeks patients with advanced ovarian cancer who plan to undergo surgery as part of their treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

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 prior data suggests that this microdevice is safe for use in ovarian cancer patients?

Research has shown that implantable microdevices (IMDs) are safe for patients with ovarian cancer. In earlier studies, researchers placed these devices inside tumors to evaluate the effectiveness of different cancer drugs. Patients tolerated the devices well, with no serious side effects from the devices themselves.

Another study tested the devices on rabbits, confirming the safety of both implantation and removal. This finding increases confidence in the procedure's safety.

As this trial is in its first phase, the primary focus is on safety. Researchers are closely monitoring how well patients tolerate the devices. This early stage is crucial to ensure the treatment does not cause harm.

Overall, initial findings suggest that using these microdevices is safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the implantable microdevice for ovarian cancer because it offers a novel way to test how different drugs affect tumor tissue directly. Unlike traditional treatments that rely on systemic administration, this microdevice allows for localized drug exposure within the tumor, providing real-time insights into drug effectiveness. This approach could lead to more personalized and effective treatment plans by identifying the best drugs for each patient's specific cancer profile, potentially reducing trial and error with systemic chemotherapy.

What evidence suggests that this microdevice is effective for ovarian cancer?

This trial will evaluate the use of an implantable microdevice for ovarian cancer. Research has shown that a small device can be placed inside ovarian tumors to deliver chemotherapy drugs directly, helping doctors assess each drug's effectiveness within the tumor. Studies have found these devices to be safe for patients with ovarian cancer. Early results suggest this method can predict the tumor's response to various treatments. This approach could lead to more personalized and effective cancer care by identifying the best drug combinations for each patient. Participants in this trial will have the microdevice placed before surgery, allowing for direct assessment of drug effects within the tumor tissue. ^{1 2 3 4 5}

Who Is on the Research Team?

Elizabeth Stover, MD, PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. aacrjournals.org aacrjournals.org/cancerres/article/85/5_Supplement/B012/751860/Abstract-B012-Clinical-trial-of-an-implantable

Clinical trial of an implantable microdevice to evaluate drug ... In summary, our clinical trial experience indicates that IMDs are safe to implant into tumors of patients with ovarian cancer and that it is ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4825177/

An implantable microdevice to perform high-throughput in ... Our fully implanted microscale device is capable of delivering precise doses of different drugs into a tumor for parallel drug efficacy assessments in vivo.

3. researchgate.net researchgate.net/publication/389772691_Abstract_B012_Clinical_trial_of_an_implantable_microdevice_to_evaluate_drug_responses_in_ovarian_cancer

Clinical trial of an implantable microdevice to evaluate drug ... In summary, our clinical trial experience indicates that IMDs are safe to implant into tumors of patients with ovarian cancer and that it is ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1936523322000869

Machine-learning aided in situ drug sensitivity screening ... We have shown how microdevices acutely implanted in SQ ovarian PDX tumor models can predict overall IP ovarian PDX tumor response to various IP-delivered drugs ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12492436/

An Interventional Radiology Method for In Situ ... A multiplex implantable microdevice assay identifies synergistic combinations of cancer immunotherapies and conventional drugs . Nat ...