60 Participants Needed

LC-OCT Imaging for Basal Cell Carcinoma

AR
Overseen ByAsk RPCI
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Roswell Park Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging technique called LC-OCT to aid in planning surgery for basal cell carcinoma (BCC), a common type of skin cancer. The goal is to determine if this noninvasive imaging provides doctors with better information before performing Mohs surgery, a precise procedure for removing BCC. Suitable participants have BCC involving superficial layers and are already scheduled for Mohs surgery. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance surgical outcomes for future BCC patients.

Do I need to stop my current medications for this 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 LC-OCT imaging is safe for presurgical assessment?

Research has shown that LC-OCT imaging examines skin layers in detail without cutting the skin. It is primarily used to diagnose basal cell carcinoma (BCC), a common type of skin cancer.

Although studies do not specifically address the safety of LC-OCT, its noninvasive nature suggests low risk. No reports of harmful side effects exist, as it neither uses radiation nor involves surgery. This makes it a safe option for patients requiring a detailed skin examination.12345

Why are researchers excited about this trial?

Researchers are excited about LC-OCT imaging for basal cell carcinoma because it offers a noninvasive way to assess the skin. Unlike traditional biopsies, which require removing a tissue sample, LC-OCT uses light to create detailed images of the skin layers, potentially providing a faster and pain-free diagnosis. This method could help doctors diagnose and monitor basal cell carcinoma more efficiently, reducing the need for invasive procedures and improving patient comfort.

What evidence suggests that LC-OCT imaging is effective for assessing basal cell carcinoma?

Research has shown that LC-OCT imaging, the focus of this trial, is a promising tool for diagnosing basal cell carcinoma (BCC), a common type of skin cancer. One study found that LC-OCT correctly identified BCC 87% of the time and correctly ruled it out 91% of the time, demonstrating its effectiveness in spotting BCC. Another study found that LC-OCT results matched traditional tissue study results 66.7% of the time for identifying different BCC types. Additionally, LC-OCT increased doctors' confidence in their diagnoses compared to standard exams. In some cases, it even identified BCC perfectly, with 100% accuracy, and ruled it out 98% of the time, highlighting its potential effectiveness.23567

Who Is on the Research Team?

GP

Gyorgy Paragh, MD

Principal Investigator

Roswell Park

Are You a Good Fit for This Trial?

This trial is for individuals who are scheduled to undergo Mohs micrographic surgery for basal cell carcinoma (BCC), a common type of skin cancer. The study aims to include those who can provide informed consent and are available for follow-up.

Inclusion Criteria

Participant must understand the investigational nature of this study and provide written consent prior to receiving any study-related procedure
I am 18 years old or older.
My doctors agree I can have Mohs surgery for my skin condition.
See 1 more

Exclusion Criteria

Unwilling or unable to follow protocol requirements
Known or reported allergy to mineral oil, the optical agent used during imaging
Any condition which in the investigator's opinion deems the subject an unsuitable candidate to undergo imaging procedure
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Procedure

Participants undergo noninvasive line field confocal optical coherence tomography (LC-OCT) imaging for presurgical assessment

1 office visit
1 visit (in-person)

Surgical Procedure

Participants undergo Mohs micrographic surgery for removal of basal cell carcinomas

1 office visit
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the imaging and surgical procedures

1.5 years

What Are the Treatments Tested in This Trial?

Interventions

  • LC-OCT Imaging
Trial Overview The study is testing the use of LC-OCT Imaging, a noninvasive imaging technique, to potentially improve the detection of cancer margins before surgery in patients with BCC.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Noninvasive Imaging Procedue -Line-field optical coherence tomography(LC-OCT)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials
427
Recruited
40,500+

Citations

Line-Field Confocal Optical Coherence Tomography for the ...We find that LC-OCT has shown promise as a clinical diagnostic aid with high sensitivity (pooled 87%) and specificity (pooled 91%) across 904 ...
Preoperative evaluation of high-risk basal cell carcinoma ...LC-OCT imaging showed an overall agreement with histopathology of 66.7% for correct BCC histopathological subtype identification (Fig. 2); Cohen's kappa ...
Is One Hour of Training Sufficient for Diagnosing Basal Cell ...Overall, diagnostic accuracy increased from 48% pre-training to 76% post-training and reached 81% when dermoscopic images were included, highlighting the ...
Line‐field confocal optical coherence tomography of basal ...Moreover, in this study, LC-OCT was shown to improve diagnostic confidence compared to the clinical and dermoscopic examinations. Interestingly, ...
FDA and EMA-approved noninvasive imaging techniques ...LC-OCT achieved perfect sensitivity of 100% and specificity of 98% for iBCC, with an AUC of 0.92, demonstrating its clear advantage in detecting ...
Line-Field Confocal Optical Coherence Tomography ...The diagnostic accuracy of LC-OCT for all BCC subtypes was 90%; we reported an overall sensitivity of 77% and a specificity of 96%.
Line‐field confocal optical coherence tomography and ...LC-OCT represents a noninvasive method which allows the visualisation of epidermal and dermal structures at cellular resolution in vivo in horizontal and ...
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