Laser Treatment for Basal Cell Carcinoma

Recruiting at 1 trial location

Overseen By Feben Messele

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Large lesions, Deep lesions, High risk, Periocular BCCs, Pregnancy, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: Varies

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new laser treatment to determine its effectiveness in treating basal cell carcinoma, a common type of skin cancer. Researchers will use optical coherence tomography, a special imaging technique, to guide the laser for precise treatment. The trial includes two groups, each receiving different laser settings to compare results. Individuals diagnosed with basal cell carcinoma through a biopsy and scheduled for treatment may qualify for this study. As an unphased trial, it offers patients the chance to contribute to innovative research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this laser treatment is safe for basal cell carcinoma?

Studies have shown that using a laser treatment guided by a special imaging technique for basal cell skin cancer is generally safe. This treatment employs a type of laser called Nd:YAG. Research indicates that while the laser treatment is effective, some patients might require multiple sessions to completely remove the tumor.

Most patients tolerate the treatment well, with few reports of serious side effects. The most common issues are mild skin reactions, which typically resolve on their own. This suggests that the treatment is relatively safe, though further research is beneficial to fully understand its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these laser treatments for basal cell carcinoma because they offer a non-invasive alternative to traditional options like surgery or topical therapies. These treatments utilize Optical Coherence Tomography (OCT) to guide the laser, offering precision that could potentially target cancer cells more accurately. The "Standard" arm uses a high fluence laser with a single pass, which might be more efficient, while the "Slow" arm uses lower fluence with multiple passes, possibly reducing side effects. This innovative approach could lead to faster recovery times and less damage to surrounding healthy skin, making it an attractive option for patients.

What evidence suggests that this trial's laser treatments could be effective for basal cell carcinoma?

This trial will compare two approaches using Nd:YAG laser treatment for basal cell carcinoma. Research has shown that combining a special imaging technique called optical coherence tomography with a Nd:YAG laser is promising for treating this common skin cancer. One study found that this method successfully treated up to two-thirds of these cancer spots. However, about 36.8% of the treated spots might not be completely removed after one treatment. The laser treatment, guided by imaging, allows doctors to focus on the cancerous area while sparing most of the surrounding healthy skin. This combination of laser and imaging offers a noninvasive alternative for those seeking options other than surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Christopher B Zachary, MD

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a confirmed diagnosis of basal cell carcinoma (BCC) who are seeking treatment and can follow instructions or have someone to help them. It's not for pregnant individuals, those unable to commit to a full year of follow-up, patients with BCCs on legs or near the eyes, or cases where the cancer is too large, deep, high-risk or has spread.

Inclusion Criteria

I can understand and follow study instructions or have someone legally authorized to help me.

I am scheduled for treatment of a biopsy-confirmed basal cell carcinoma.

Exclusion Criteria

Inability to understand and/or carry out instructions

I have skin cancer on my legs that might not heal well.

My skin cancer near the eye could be risky for laser treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive optical coherence tomography guided laser treatment for basal cell carcinoma using the long-pulse Nd:YAG 1064nm laser

Varies

Follow-up

Participants are monitored for safety, effectiveness, and cosmetic outcomes after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Optical Coherence Tomography Guided Laser Treatment

Trial Overview The study tests how well a type of laser called the 1064 nm long-pulse Nd:YAG can treat basal cell carcinoma when guided by optical coherence tomography—a technique that uses light waves to take cross-section pictures of skin.

How Is the Trial Designed?

Group I: Standard Active Control 1 Intervention

1064 Long-pulse Nd:YAG laser Fluence: 120 J/cm2 Number of passes: Single Spot size: 2 cm Pulse width: 8-10 msec

Group II: Slow Active Control 1 Intervention

1064 Long-pulse Nd:YAG laser Fluence: 20-30 J/cm2 Number of passes: Multiple Spot size: 2 cm Pulse width: 8-10 msec

Optical Coherence Tomography Guided Laser Treatment is already approved in European Union, United States for the following indications:

Approved in European Union as Nd:YAG Laser Treatment for:

• Basal Cell Carcinoma

Approved in United States as Nd:YAG Laser Treatment for:

• Basal Cell Carcinoma

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Christopher Zachary

Lead Sponsor

Trials

1

Recruited

40+

Published Research Related to This Trial

In a study involving 10 patients with basal cell carcinoma (BCC), treatment with a pulsed 1064 nm Nd:YAG laser resulted in a 92% rate of complete histologic clearance after just one session, indicating high efficacy for this non-surgical approach.

The laser treatment was well tolerated with no significant adverse events or scarring reported, suggesting it is a safe alternative to traditional surgical methods for treating BCC on the trunk and extremities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

1064 nm long-pulsed Nd:YAG laser treatment of basal cell carcinoma. Ortiz, AE., Anderson, RR., Avram, MM.[2015]

CO2 laser vaporization and Nd:YAG laser coagulation are effective treatment options for various malignant skin tumors, including basal cell carcinomas and squamous cell carcinomas, but are not yet standard therapies.

Photodynamic therapy (PDT) is still experimental for treating skin tumors, primarily used for basal cell carcinomas, indicating a need for further clinical studies to establish its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser therapy of skin tumors. Landthaler, M., Szeimies, RM., Hohenleutner, U.[2019]

The Nd:YAG laser treatment for basal cell carcinoma (BCC) showed a high efficacy, with 70.4% of lesions clearing after just one treatment and complete clinical and subclinical tumor clearance observed in all cases two months after the final treatment.

The study highlighted that factors such as lesion size, specific tumor subtypes, and immunosuppression can affect treatment outcomes, but overall, the recurrence rates were very low, at 1.7% clinically and 4.2% subclinically after one year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining Nd:YAG laser with optical coherence tomography for nonsurgical treatment of basal cell carcinoma. Markowitz, O., Bressler, MY.[2022]

In a study involving 37 patients with basal cell carcinoma (BCC), treatment with continuous wave Nd:Yag laser-induced hyperthermia resulted in a 97.3% complete cure rate, demonstrating its high efficacy.

The procedure, performed as an outpatient treatment, showed minimal complications and only a 2.7% recurrence rate over a follow-up period of 3-5 years, suggesting it is a safe and effective alternative for BCC management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous-wave Nd:Yag laser hyperthermia: a successful modality in treatment of basal cell carcinoma. El-Tonsy, MH., El-Domyati, MM., El-Sawy, AE., et al.[2007]

Nd:YAG laser therapy was successfully used to treat 94 skin lesions in 51 patients, demonstrating its effectiveness for various skin tumors, including basal-cell carcinomas and actinic keratosis.

The treatment is advantageous as it can often be completed in a single outpatient procedure, making it a convenient option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of Nd:YAG laser for treatment of basal-cell carcinomas and some premalignant conditions]. Rubisz-Brzezińska, J., Bendkowski, W.[2007]

In a study involving 33 subjects with biopsy-proven basal cell carcinoma (BCC), the 1064 nm Nd:YAG laser achieved a 90% histologic clearance rate after just one treatment, demonstrating its efficacy as a non-surgical option.

The laser treatment was well tolerated with minimal side effects, such as temporary swelling and redness, and no significant adverse events were reported, making it a safe alternative for patients who are not suitable for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An expanded study of long-pulsed 1064 nm Nd:YAG laser treatment of basal cell carcinoma. Ortiz, AE., Anderson, RR., DiGiorgio, C., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36740365/

Optical coherence tomography-guided Nd:YAG laser ... Our results demonstrate that the ITC rate of BCC treated with the Nd:YAG laser is much higher (up to one-third) than reported, although the ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/lsm.23638

Optical coherence tomography‐guided Nd:YAG laser ... This study evaluates the efficiency of laser treatment by FU OCT. We pursue a patient-focused approach and combine OCT with Nd:YAG laser treatment in one ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04744935

Optical Coherence Tomography Guided Laser Treatment ... The purpose of this pilot study is to examine the treatment basal cell carcinoma (BCC) with laser technology under the guidance of optical coherence tomography ...

4. researchgate.net researchgate.net/publication/368296627_Optical_coherence_tomography-guided_NdYAG_laser_treatment_and_follow-up_of_basal_cell_carcinoma

Optical coherence tomography‐guided Nd:YAG laser ... Out of 19 lesions with at least one additional laser treatment, 7 lesions (36.8%) suffered from incomplete tumor removal. In 46.7% of the treated lesions, the ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34289512/

Combining Nd:YAG laser with optical coherence ... Conclusions: The Nd:YAG nonablative laser can offer an effective treatment for BCCs when used with noninvasive diagnostic tools such as OCT.

6. ejcancer.com ejcancer.com/article/S0959-8049(23)00356-8/fulltext

European consensus-based interdisciplinary guideline for ... These guidelines were written to assist clinicians in diagnosis and treatment of basal cell carcinoma (BCC) patients. This update was initiated ...