RCM/OCT-Guided Radiation Therapy for Basal Cell Carcinoma

Not currently recruiting at 6 trial locations

Overseen By Anthony Rossi, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Radiation hypersensitivity, Prior cancer radiotherapy, others

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

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to guide radiation therapy for basal cell carcinoma, a common type of skin cancer, using advanced imaging tools. Researchers aim to determine the method's effectiveness and potential side effects. The trial also examines the treatment's impact on quality of life through patient questionnaires. It suits individuals with up to three basal cell tumors that are not deeply invasive and who are open to imaging and radiation therapy. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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 team or your doctor.

What prior data suggests that the RCM/OCT device is safe for guiding radiation therapy?

Research shows that radiation therapy (RT) is generally safe and well-tolerated by patients. It has treated various types of cancer for many years. In this trial, RT uses advanced imaging tools called reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) to guide treatment. This new method aims to target cancer cells more precisely, potentially reducing side effects.

While specific data on the safety of RCM/OCT-guided RT for basal cell carcinoma (BCC) is not yet available, earlier studies using similar technology for other skin conditions have shown promising results with manageable side effects. The trial is currently testing how well patients handle the treatment, indicating researchers' confidence in its safety for broader use.

For those considering joining the trial, it's important to know that this technology has been used successfully in other skin cancer treatments, offering some reassurance about its safety. Participants will be closely monitored for any side effects, and doctors will assess how the treatment affects their quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for basal cell carcinoma, which often involve surgery, the RCM/OCT-Guided Radiation Therapy is unique because it uses advanced imaging techniques to guide the radiation therapy. This approach combines Reflectance Confocal Microscopy (RCM) and Optical Coherence Tomography (OCT) to precisely target the cancerous cells, potentially reducing the need for invasive surgery. Researchers are excited about this method because it allows for real-time assessment of the tumor before and after treatment, paving the way for a more personalized and less invasive treatment plan. If successful, this could lead to fewer side effects and improved patient outcomes, making it a promising option for those affected by basal cell carcinoma.

What evidence suggests that the RCM/OCT-guided radiation therapy is effective for basal cell carcinoma?

Research has shown that radiation therapy effectively treats basal cell carcinoma, particularly in areas where appearance and function matter. In this trial, participants will receive radiation therapy guided by reflectance confocal microscopy (RCM) and optical coherence tomography (OCT), which are special imaging tools that provide detailed views of the skin. Studies have demonstrated that these tools can help doctors target the cancer more precisely. This precision may improve outcomes by focusing treatment on cancer cells while sparing healthy tissue. Early findings suggest that this approach could enhance the effectiveness of radiation therapy for basal cell carcinoma. ^{1 3 4 6 7}

Who Is on the Research Team?

Christopher Barker, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with biopsy-proven basal cell carcinoma (BCC) that's not deeply invasive or larger than 40mm. Up to three tumors can be treated, and they mustn't have bone erosion or significant nerve invasion. Participants need to understand English/Spanish for questionnaires and be considered suitable for RCM/OCT imaging and radiation therapy by the investigator.

Inclusion Criteria

I can complete health surveys in English or Spanish.

My skin cancer has not grown deep into my skin.

I have been diagnosed with basal cell carcinoma through a biopsy.

Exclusion Criteria

I am willing to follow all treatment and follow-up procedures.

I've had radiotherapy that now makes further radiation unsafe, according to my doctor.

Medical contraindication to radiation therapy in the opinion of the investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pretreatment Imaging

Participants undergo pretreatment RCM/OCT imaging

1 week

Radiation Therapy

Participants receive radiation therapy guided by RCM/OCT

6 weeks

Post-treatment Assessment

Participants undergo post-treatment assessment with RCM/OCT and biopsy

1 week

Follow-up

Participants are monitored for clinical evidence of recurrence

up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Radiation Therapy
• Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided

Trial Overview The study tests if guiding radiation therapy with a new device combining reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) is effective in treating BCC. It also examines side effects of this guided RT and assesses patients' quality of life before and after treatment through questionnaires.

How Is the Trial Designed?

Group I: Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation Therapy Experimental Treatment 2 Interventions

If eligible, patients will undergo pretreatment RCM/OCT imaging, followed by RT. Six weeks after the completion of RT, patients will undergo post-treatment assessment with RCM/OCT and biopsy. If residual carcinoma is detected on the biopsy, surgical excision of the BCC will be performed. If no residual carcinoma is detected on the biopsy, the patient will be monitored for clinical evidence of recurrence for up to 3 years.

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in United States as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Physical Sciences Inc.

Collaborator

Trials

2

Recruited

50+

Published Research Related to This Trial

In a study of 658 patients with high-risk endometrial cancer, intensity-modulated radiation therapy (IMRT) was associated with significantly fewer grade ≥2 adverse events, such as diarrhea and hematologic issues, compared to 3-dimensional conformal radiation therapy (3DCRT) during follow-up.

IMRT also showed a trend towards fewer patient-reported symptoms like bowel urgency and abdominal cramps during treatment, indicating it may provide a better quality of life for patients undergoing radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation Therapy Techniques and Treatment-Related Toxicity in the PORTEC-3 Trial: Comparison of 3-Dimensional Conformal Radiation Therapy Versus Intensity-Modulated Radiation Therapy. Wortman, BG., Post, CCB., Powell, ME., et al.[2022]

Intensity-modulated radiation therapy (IMRT) resulted in significantly lower rates of acute and late genitourinary (GU) and gastrointestinal (GI) toxicity compared to (125)I seed implants, with 3-year rates of 3.5% GU and 2.4% GI toxicity for IMRT versus 19.2% GU and 7.7% GI for (125)I.

Both treatments showed similar biochemical failure rates, with IMRT having a 4-year freedom from failure rate of 99.5% compared to 93.5% for (125)I, indicating that while both are effective, IMRT may be safer with fewer side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of acute and chronic toxicity for men with low-risk prostate cancer treated with intensity-modulated radiation therapy or (125)I permanent implant. Eade, TN., Horwitz, EM., Ruth, K., et al.[2022]

In a study of 22 patients with locally advanced rectal cancer, image-guided radiotherapy (IGRT) led to complete surgical resection in all cases, with 32% of patients showing no residual tumor after treatment.

The treatment was associated with minimal toxicity, although one patient experienced severe side effects likely due to an overdose of capecitabine, suggesting that IGRT is a promising approach for reducing complications in rectal cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of image-guided radiotherapy for locally advanced rectal cancer. Nguyen, NP., Ceizyk, M., Almeida, F., et al.[2011]

Image-guided radiation therapy (IGRT) has evolved significantly and is now widely used in routine clinical practice, emphasizing the importance of quality and patient safety in its application across various treatment techniques and anatomical sites.

The American Society for Radiation Oncology recommends a comprehensive quality-assurance program and an interdisciplinary team approach to ensure IGRT is performed safely and effectively, highlighting the need for ongoing updates to practice guidelines as technology advances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. Qi, XS., Albuquerque, K., Bailey, S., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05294120

A Study on Radiation Therapy Guided by the Reflectance ... The purpose of this study is to find out if radiation therapy (RT) guided by the new reflectance confocal microscopy (RCM)/optical coherence tomography (OCT) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5995139/

Handheld optical coherence tomography–reflectance confocal ... We present a hand-held implementation and preliminary evaluation of a combined optical coherence tomography (OCT) and reflectance confocal microscopy (RCM) ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-02756

Radiation Therapy Guided by the Reflectance Confocal ... This phase II trial tests whether radiation therapy guided by the reflectance confocal microscopy (RCM)/optimal coherence tomography (OCT) device works in ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05294120/a-study-on-radiation-therapy-guided-by-the-reflectance-confocal-microscopy-rcm-optimal-coherence-tomography-oct-device-in-people-with-basal-cell-carcinoma?dt_type=new&state=NY&city=Commack

A Study on Radiation Therapy Guided by the Reflectance ... The purpose of this study is to find out if radiation therapy (RT) guided by the new reflectance confocal microscopy (RCM)/optical coherence ...

5. withpower.com withpower.com/trial/phase-2-carcinoma-basal-cell-2-2022-f9bc0

RCM/OCT-Guided Radiation Therapy for Basal Cell ... Research shows that radiation therapy is effective for treating basal cell carcinoma, especially in areas where preserving appearance and function is important, ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/record/NCT05294120?term=physio+OR+physical+therapy+OR+exercise+therapy+OR+physiotherapy

A Study on Radiation Therapy Guided by the Reflectance ... A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11545539/

Treating Skin Cancer in This Era—A Case Series This study demonstrates successful non-invasive management of localized NMSC using RCM and SRT. RCM was able to non-invasively demonstrate complete tumor ...