Intra-operative Imaging for Ovarian Cancer

Recruiting at 10 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

Trial Summary

What is the purpose of this trial?

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 complications after surgery for ovarian cancer, compared with standard intra-operative assessments alone. The PINPOINT endoscopic fluorescence imaging system uses a special camera and a fluorescent (glowing) dye that can evaluate the blood flow of the bowel in real-time. If there is an area that appears concerning, the surgeon can correct the problem during the procedure.

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 data supports the effectiveness of the treatment PINPOINT endoscopic fluorescence imaging system for ovarian cancer?

Research shows that fluorescence-guided surgery, which is similar to the PINPOINT system, helps doctors see tiny tumor deposits during surgery for ovarian cancer. This can improve the chances of removing all cancerous tissue, which is important for better long-term survival. ^{1 2 3 4 5}

Is the PINPOINT endoscopic fluorescence imaging system safe for use in humans?

The PINPOINT Endoscopic Fluorescence Imaging System has been used in surgeries for conditions like colorectal cancer, and while the studies focus on its technical capabilities, they do not report any specific safety concerns, suggesting it is generally safe for use in humans. ^{1 4 6 7 8}

How is the PINPOINT endoscopic fluorescence imaging system treatment different from other treatments for ovarian cancer?

The PINPOINT endoscopic fluorescence imaging system is unique because it uses real-time fluorescence imaging to help surgeons see and remove tiny tumor deposits during surgery, which is crucial for improving outcomes in ovarian cancer treatment. ^{1 2 3 9 10}

Research Team

Mario Leitao, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

References

1. United States 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. [2013]

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

Intraoperative fluorescence imaging of peritoneal dissemination of ovarian carcinomas. A preclinical study. [2022]

3. England 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. [2023]

4. China pubmed.ncbi.nlm.nih.gov

[Application of multi-tumor markers in ovarian carcinoma]. [2015]

5. United States 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. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Intraoperative Identification of Colonic Tumor Sites Using a Near-Infrared Fluorescence Endoscopic Imaging System and Indocyanine Green. [2018]

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

Characterization and evaluation of the artemis camera for fluorescence-guided cancer surgery. [2022]

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

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

9. England pubmed.ncbi.nlm.nih.gov

Pilot Clinical Evaluation of a Confocal Microlaparoscope for Ovarian Cancer Detection. [2018]

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

Concurrent video-rate color and near-infrared fluorescence laparoscopy. [2019]