Confocal Laser Endomicroscopy for Pancreatic Cysts

(CLIMB Trial)

Recruiting at 9 trial locations

Overseen By Diana Burke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Pregnancy, Bleeding diathesis, Allergy, others

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

Compensation: Varies

Number of Visits: 1

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method called Confocal Laser Endomicroscopy to diagnose pancreatic cysts (fluid-filled sacs). The goal is to determine if this method can better identify cyst types compared to current techniques. Suitable participants have a pancreatic cyst larger than 2 cm and are considering surgery. Participants will undergo an ultrasound-guided procedure to examine the cysts. Researchers aim for this new method to lead to more accurate diagnoses, potentially guiding better treatment decisions. As a Phase 2 trial, the study measures how well this imaging method works in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking diagnostic advancements.

Do I need to stop my current medications for the trial?

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 this method is safe for evaluating pancreatic cystic lesions?

Research has shown that confocal laser endomicroscopy (CLE) is very safe. CLE, a new tool used during endoscopy, closely examines tissue surfaces in real-time, aiding doctors in making more accurate diagnoses.

Studies have found that patients tolerate CLE well, with no major safety issues reported. The procedure uses a dye called fluorescein, which is safe and approved by the FDA for use in eye exams.

Overall, CLE is considered a safe and effective method for improving diagnosis in various conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Confocal Laser Endomicroscopy (CLE) is unique because it offers a real-time, microscopic view of pancreatic cystic lesions, which can improve diagnosis accuracy. Unlike traditional imaging methods like MRI or CT scans, which provide broader anatomical views, CLE enables direct visualization at the cellular level. This precision can help differentiate between benign and potentially malignant cysts more effectively, potentially leading to more accurate and timely treatment decisions. Researchers are excited about CLE because it could revolutionize how pancreatic cystic lesions are diagnosed, making the process faster and potentially more reliable.

What evidence suggests that Confocal Laser Endomicroscopy is effective for evaluating pancreatic cystic lesions?

Studies have shown that confocal laser endomicroscopy, a special type of microscope for internal examination, effectively diagnoses pancreatic cysts. It accurately identifies the condition 94% of the time and rules it out 95% of the time. This technology detects more tumors with fewer biopsies than traditional methods, making it both efficient and less invasive. It also aids doctors in making quick decisions during surgery by providing real-time images. Overall, this method shows promise for accurately diagnosing pancreatic conditions. ^{6 7 8 9 10}

Who Is on the Research Team?

Somashekar Krishna, MD, MPH

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

Inclusion Criteria

All patients referred for EUS-FNA of accessible PCL where surgery is contemplated

Minimum cyst size should be ≥ 2.0 cm as determined by prior cross-sectional imaging studies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

EUS Evaluation and Imaging

EUS-guided nCLE imaging is performed followed by EUS-guided FNA and aspiration of cyst fluid for analysis

1-2 weeks

1 visit (in-person)

Surgical Intervention

Surgery is performed based on institutional multidisciplinary tumor board meetings, with surgical histopathology serving as the 'gold standard' for diagnosis

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 months

What Are the Treatments Tested in This Trial?

Interventions

• Confocal Laser Endomicroscopy

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

American College of Gastroenterology

Collaborator

Trials

40

Recruited

6,900+

The National Pancreas Foundation

Collaborator

Trials

5

Recruited

680+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK126332/

Efficacy of confocal laser endomicroscopy for discriminating ... The 15 trials showed that confocal endomicroscopy had high sensitivity (94%, 95% CI 88 to 97) and specificity (95%, 95% CI 89 to 97) for discriminating between ...

2. link.springer.com link.springer.com/article/10.1007/s00464-025-12297-w

Probe-based confocal laser endomicroscopy A study by Kiesslich et al. identified 4.75-fold more neoplasms with 50% fewer biopsies when pCLE was utilized compared to a traditional ...

3. karger.com karger.com/dig/article/doi/10.1159/000548414/935292/Clinical-Application-of-Confocal-Laser

Clinical Application of Confocal Laser Endomicroscopy in ... For clinical recurrence, the sensitivity and specificity were 80% and 77%, respectively, with a comparable overall accuracy. These results ...

4. mdpi.com mdpi.com/2075-4418/15/4/499

Confocal Laser Endomicroscopy: Enhancing Intraoperative ... This technique allows for intraoperative tumor characterization and reduces dependence on time-consuming frozen-section analyses.

5. nature.com nature.com/articles/s41598-022-11385-4

Diagnostic accuracy of probe-based confocal laser ... Good image quality achieved 100% accuracy while poor image accuracy was only 79%, indicating that good image quality can significantly improve ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32405892/

SAGES TAVAC safety and efficacy analysis confocal laser ... CLE has an excellent safety profile. CLE can increase the diagnostic accuracy in a number of gastrointestinal pathologies.

7. asge.org asge.org/docs/default-source/education/Technology_Reviews/doc-confocal_laser_endomicroscopy.pdf

Confocal laser endomicroscopy Technical data are gathered from traditional and Web-based publications, proprietary publications, and informal communications with pertinent vendors.

8. link.springer.com link.springer.com/article/10.1007/s00464-020-07607-3

SAGES TAVAC safety and efficacy analysis confocal laser ... Confocal laser endomicroscopy (CLE) is a novel endoscopic adjunct that allows real-time in vivo histological examination of mucosal surfaces.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT07040670?term=AREA%5BConditionSearch%5D(Congenital%20lobar%20emphysema%20OR%20%22CLE%22%20OR%20%22%20congenital%20lobar%20hyperinflation%22%20OR%20%22%20emphysema,%20congenital%20lobar%22%20OR%20%22%20infantile%20lobar%20hyperinflation%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=5

Study Details | NCT07040670 | Diagnostic Yield and Safety ... Study Overview. Comparison of the Diagnostic Yield and Safety Between Confocal Laser Endomicroscopy-Assisted Endobronchial Ultrasound-Guided Transbronchial ...

10. gastrojournal.org gastrojournal.org/article/S0016-5085(10)00888-7/fulltext

Confocal Laser Endomicroscopy: Technical Advances and ... Fluorescein is a nontoxic agent and FDA-cleared for diagnostic angiography of the retina. After intravenous injection fluorescein distributes within 7–14 ...