Intra-operative Imaging for Ovarian Cancer

Recruiting at 11 trial locations

Overseen By Dennis Chi, MD

Age: Any Age

Sex: Female

Trial Phase: Phase 3

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Allergy to ICG, Colostomy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

310 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether the PINPOINT endoscopic fluorescence imaging system can reduce complications during ovarian cancer surgery. The PINPOINT system uses a glowing dye and a camera to monitor blood flow in real-time, enabling surgeons to address issues immediately. The trial compares surgeries using this system with those using standard methods. Individuals diagnosed with ovarian or related cancers and scheduled for specific types of surgery may be eligible to participate. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking advancement in surgical care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the PINPOINT imaging system is safe for intra-operative use?

Research has shown that the PINPOINT imaging system aids in surgeries by checking blood flow and reducing complications. This system employs a special camera and glowing dye to allow surgeons to see blood flow in real-time. Studies have found this method useful during surgeries, enabling surgeons to address problems immediately.

Detailed safety information about using the PINPOINT system specifically in ovarian cancer surgery is limited. However, the trial's later stages suggest that earlier studies have demonstrated some level of safety. By this point in research, a treatment has typically been tested on many patients with manageable side effects.

The PINPOINT system is a surgical tool, not a drug, so it functions differently than medications. It does not have the same side effects that drugs might have. Instead, it enhances surgical safety by providing doctors with better information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for ovarian cancer?

Researchers are excited about the PINPOINT endoscopic fluorescence imaging system for ovarian cancer surgery because it brings a new level of precision to the operating room. Unlike traditional methods that rely on visual inspection and palpation during surgery, this system uses near-infrared (NIR) angiography to illuminate and assess blood flow in real-time. This can help surgeons identify cancerous tissue more accurately and ensure better perfusion during anastomosis, potentially leading to improved surgical outcomes. By enhancing visualization, this technique aims to reduce complications and improve recovery times, offering a promising advancement over current surgical standards.

What evidence suggests that the PINPOINT imaging system is effective for reducing complications in ovarian cancer surgery?

Research shows that the PINPOINT endoscopic fluorescence imaging system can help reduce complications during ovarian cancer surgery. In this trial, participants in Arm B will receive additional assessment using this system, potentially lowering the risk of unwanted connections between the bowel and other tissues by providing surgeons with a clear, real-time view of blood flow. This enables them to identify and address potential issues immediately. The system uses a special glowing dye to make blood flow visible, which may lead to safer surgeries and better outcomes. Early findings are promising, but more data is needed to confirm these benefits. Participants in Arm A will undergo the standard technique without this imaging system. ^{1 3 4 6 7}

Who Is on the Research Team?

Mario Leitao, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for women with ovarian, fallopian tube, or primary peritoneal cancer who are scheduled for surgery to remove the tumor. They must be enrolled before surgery and have a part of their bowel removed that's close to the rectum. Women can't join if they're allergic to ICG dye or need a permanent colostomy.

Inclusion Criteria

I have had surgery to remove part of my lower colon or rectum.

I am scheduled for surgery to remove as much of my cancer as possible.

I have been diagnosed with ovarian, fallopian tube, or peritoneal cancer.

Exclusion Criteria

I need a permanent colostomy.

You have had a bad allergic reaction to ICG before.

I have not had surgery to remove part of my rectum or sigmoid colon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Intra-operative Imaging

Participants undergo rectosigmoid resection with intra-operative imaging using the PINPOINT system to assess blood flow and reduce complications

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, focusing on the reduction of 30-day postoperative anastomotic leaks

45 days

What Are the Treatments Tested in This Trial?

Interventions

• PINPOINT endoscopic fluorescence imaging system

Trial Overview The study tests if using the PINPOINT system during surgery helps prevent leaks and complications by showing blood flow in the bowel with a special camera and glowing dye. This could allow surgeons to fix issues on-the-spot compared to standard methods.

How Is the Trial Designed?

Group I: Arm B Experimental Treatment 3 Interventions

Randomized to additional assessment of proximal colonic stump and anastomotic perfusion using NIR angiography

Group II: Arm A Active Control 1 Intervention

Randomized to standard technique and assessment of anastomosis without the use of NIR angiography

PINPOINT endoscopic fluorescence imaging system is already approved in United States, European Union for the following indications:

Approved in United States as PINPOINT for:

• Visualization of tissue perfusion and biliary ducts during minimally invasive procedures
• Assessment of blood flow in vessels and tissue perfusion in colorectal, esophageal, and bariatric surgeries

Approved in European Union as PINPOINT for:

• Visualization of tissue perfusion and biliary ducts during minimally invasive procedures
• Assessment of blood flow in vessels and tissue perfusion in colorectal, esophageal, and bariatric surgeries

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

The PINPOINT Endoscopic Fluorescence Imaging System enhances laparoscopic procedures by providing both conventional white light and near-infrared fluorescence imaging using indocyanine green (ICG), which can improve visualization during surgery.

This high-definition system is designed to aid in the identification of tissues and structures, potentially leading to better surgical outcomes in colorectal procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Near-infrared fluorescence laparoscopy--technical description of PINPOINT® a novel and commercially available system. Fengler, J.[2015]

Fluorescence-guided surgery is a promising technique for improving the visualization of tumors during surgery for epithelial ovarian cancer, allowing for better identification of small tumor masses.

Several targeted fluorescent probes for ovarian cancer are in development, with some imaging devices already demonstrating proof of concept for use in open surgeries, highlighting the potential for clinical application despite existing challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updates on fluorescent probes and open-field imaging methods for fluorescence-guided cytoreductive surgery for epithelial ovarian cancer: A review. Sun, C., Huang, Y., Jiang, C., et al.[2023]

The confocal fluorescence microlaparoscope demonstrated a high efficacy in detecting ovarian cancer, achieving an average area under the receiver operating characteristic curve (AUC) score of 0.88, indicating strong diagnostic performance.

In vivo imaging with the microlaparoscope showed similar effectiveness to ex vivo imaging, suggesting that this technology can reliably distinguish between normal and malignant ovarian tissue during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Clinical Evaluation of a Confocal Microlaparoscope for Ovarian Cancer Detection. Risi, MD., Rouse, AR., Chambers, SK., et al.[2018]

A novel video-rate imaging laparoscope has been developed that can capture both color and near-infrared fluorescence images simultaneously, enhancing the ability to identify tumors during surgery.

This advanced imaging system shows promise for improving intra-operative guidance in cancer detection, as demonstrated in tests on phantoms and in a mouse model of human tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concurrent video-rate color and near-infrared fluorescence laparoscopy. Glatz, J., Varga, J., Garcia-Allende, PB., et al.[2019]

The PINPOINT® Endoscopic Fluorescence Imaging System successfully identified colonic tumor sites in 93.8% of cases during laparoscopic colorectal surgery, demonstrating high efficacy in intraoperative visibility.

The use of indocyanine green (ICG) for tumor site identification was safe, with no adverse reactions or complications reported, indicating it is a reliable method for enhancing surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Identification of Colonic Tumor Sites Using a Near-Infrared Fluorescence Endoscopic Imaging System and Indocyanine Green. Watanabe, M., Murakami, M., Ozawa, Y., et al.[2018]

The study demonstrated that an intra-operative fluorescence imaging system using an α(v)β(3)-integrin targeted probe achieved a high sensitivity of 95% and specificity of 88% for detecting ovarian cancer tumors in mice.

With a diagnostic accuracy of 96.5% and a mean target to background ratio of 2.2, this imaging technique shows promise for improving tumor visualization and complete resection during surgery, paving the way for potential clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time near infrared fluorescence (NIRF) intra-operative imaging in ovarian cancer using an α(v)β(3-)integrin targeted agent. Harlaar, NJ., Kelder, W., Sarantopoulos, A., et al.[2013]

The study validated the use of a fluorescent tracer, AngioStamp®, which targets the α(v)β₃ integrin, to effectively detect small residual ovarian cancer cells and metastases smaller than 500μm during surgery.

This technique demonstrated the ability to visualize all types of human ovarian adenocarcinoma cell lines in animal models, suggesting it could significantly improve the management of ovarian cancer by identifying minimal residual disease that often leads to recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative fluorescence imaging of peritoneal dissemination of ovarian carcinomas. A preclinical study. Mery, E., Jouve, E., Guillermet, S., et al.[2022]

Using a combination of multiple tumor markers improved the sensitivity and specificity for diagnosing ovarian cancer, achieving 86.6% sensitivity and 94.4% specificity compared to 83.6% sensitivity and 85.9% specificity for the CA125 marker alone.

Monitoring multi-tumor markers over one year after surgery in ovarian cancer patients helped in early detection of recurrence, indicating its potential for enhancing postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of multi-tumor markers in ovarian carcinoma]. Feng, J., Qian, H., Tian, Y.[2015]

The Artemis handheld NIR fluorescence camera can detect tumor cells as small as 1 mm³ and has a minimum detectable cell count of 2 × 10⁵ cells, making it effective for real-time visualization during cancer surgeries.

In clinical evaluations, the Artemis successfully identified six malignant lesions in patients with liver metastases, demonstrating its potential utility in fluorescence-guided cancer surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization and evaluation of the artemis camera for fluorescence-guided cancer surgery. van Driel, PB., van de Giessen, M., Boonstra, MC., et al.[2022]

Targeted fluorescence-guided cytoreductive surgery (FGCS) using folate receptor alpha (FRα) and HER2 has shown feasibility in detecting tumor deposits in both animal models and human patients with epithelial ovarian cancer (EOC), potentially leading to less residual disease after surgery.

Human studies indicated that FGCS significantly improved the detection rate of tumor deposits, with a sensitivity of 85.9%, although false positives were noted, primarily from lymph nodes, highlighting the need for further research to confirm survival benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of folate receptor alpha- and HER2-targeted intraoperative fluorescence-guided cytoreductive surgery in women with epithelial ovarian cancer: A systematic review. de Jong, JM., Hoogendam, JP., Braat, AJAT., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04878094

A Study of Intra-operative Imaging in Women With Ovarian ... The purpose of this study is to find out whether using the PINPOINT imaging system intra-operatively can reduce the risk of anastomotic leaks and other ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28760628/

Laparoscopic Minimally Invasive Approach to Sentinel ... The minimally invasive approach in combination with the ICG near-infrared fluorescence S1 PinPoint fluorescence system seems feasible, and, ...

3. cancer.gov cancer.gov/clinicaltrials/NCI-2021-04262

Study of Intra-operative Imaging in Women with Ovarian ... Using the PINPOINT imaging system intra-operatively may reduce the risk of anastomotic leaks and other complications after surgery for ovarian cancer, compared ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12382125/

Application of fluorescent tracers in ovarian cancer surgical ... Fluorescence-guided surgery is a potentially safe and applicable technique in ovarian cancer surgery. However, considering the small number of ...

5. stryker.com stryker.com/us/en/endoscopy/products/pinpoint.html

PINPOINT PINPOINT offers simultaneous, real-time, high definition white light and fluorescence imaging through a single laparoscope.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5264387/

Novel approach for the detection of intraperitoneal ... Patients with epithelial ovarian cancer have the best overall survival when maximal surgical effort is accomplished.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2372770521000875

Fluorescent imaging for cancer therapy and cancer gene ... This review will summarize the most promising optical imaging agents and detection devices for cancer clinical research and clinical care.