Photodynamic Therapy for Basal Cell Carcinoma

Overseen By Allan Halpern, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Immunosuppressants, Pain medications

Disqualifiers: High-risk BCC, Gorlin syndrome, 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: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating basal cell carcinoma, a common type of skin cancer, using a combination of the drug ALA (aminolevulinic acid) and light. The study aims to determine if injecting ALA into the skin and activating it with light is safe and results in only mild side effects. The trial has two parts: some participants will receive the light treatment, while others will have their tumors removed without it. Individuals with untreated, low-risk basal cell carcinoma less than 1 cm in size on their scalp, arms, or body may be suitable for this trial, especially if they can use a smartphone to document their progress. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

If you are taking prescription pain medications or cannot stop over-the-counter pain medications, you may not be eligible for this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using a jet injector to deliver ALA, a light-activated drug, is safe and well-tolerated for treating basal cell carcinoma, a type of skin cancer. Earlier studies found this treatment method to be safe, with only mild or few side effects. Patients reported comfort with this approach, and satisfaction scores averaged 9.4 out of 10. These results suggest that a jet-injection device could offer a promising and gentle treatment option for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for basal cell carcinoma, which often involve surgical excision or topical medications, the new approach being tested uses photodynamic therapy (PDT) with a jet-injection of aminolevulinic acid (ALA). This method is exciting because it potentially offers a non-invasive alternative that combines a unique delivery mechanism—jet-injection—to enhance ALA absorption in the skin. After the ALA is absorbed, the area is exposed to red light, which activates the compound to selectively target and destroy cancer cells. Another intriguing aspect is the quick treatment turnaround, with just a few hours of incubation and rapid results compared to more prolonged traditional options. Researchers are particularly optimistic about this innovative delivery method and the potential for effective, less invasive treatment.

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

Research has shown that a jet-injection method combined with photodynamic therapy (PDT) can effectively treat basal cell carcinoma (BCC). This approach uses 5-aminolevulinic acid (ALA). In this trial, one group of participants will receive PDT treatment with jet-injections of ALA, followed by incubation and illumination. Studies have found that this treatment is manageable and effective for both surface-level and slightly deeper low-risk BCC. Specifically, patients experienced a significant decrease in skin reactions, with scores dropping from an average of 5 to 0.5. This indicates that the treatment not only works but also leads to milder side effects over time. Overall, these findings support the potential effectiveness of using ALA with jet injection for treating BCC. ^{1 2 4 6 7}

Who Is on the Research Team?

Anthony Rossi, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with small, untreated basal cell carcinoma on the scalp, extremities, or trunk. Participants must be in good health, able to take photos of their skin cancer and use a smartphone app. Pregnant women, those with certain BCC subtypes or skin conditions that could affect results are excluded.

Inclusion Criteria

Owner of a smartphone (Android or iPhone). Patients without a working smartphone will not be considered eligible for this study

Being able to download application on their phone

I am legally able to make my own decisions and can sign consent forms.

Exclusion Criteria

You have a history of keloids that are considered important to the doctor conducting the study.

You have other skin conditions in the area where the treatment will be applied.

Subjects with a tattoo in the treatment area which may interfere with or confound the evaluation of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PDT treatment with jet-injections of ALA followed by 3h incubation and illumination with red light. Treatment is repeated after 2 weeks.

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations at Day 0, Day 3, Day 14, Day 17, and 3 months post-treatment.

3 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Illumination
• Incubation
• Jet injection of ALA
• Surgical excision

Trial Overview The study tests if using a jet-injection device to inject ALA into the skin followed by light activation is an effective treatment for basal cell carcinoma. It aims to determine safety and severity of side effects associated with this photodynamic therapy approach.

How Is the Trial Designed?

Group I: Tumor Excision, No Illumination Experimental Treatment 3 Interventions

The first four patients will not receive illumination but have their tumors excised after jet-injection (AirGent2.0) of ALA (Levulan Kerastick), and 3h incubation; this will be done to assess biodistribution of ALA through fluorescence microscopy.

Group II: PDT treatment with jet-injections Experimental Treatment 4 Interventions

Patient 5-16 will receive PDT treatment with jet-injections of ALA followed by 3h incubation under occlusion and thereafter illumination with red light (total dose 75 J/cm2). In patient 5-16, the PDT treatment will be repeated after 2 weeks.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11335321/

Jet-Injection Assisted Photodynamic Therapy for ... This prospective open-label pilot trial investigated the safety and efficacy of photosensitizer jet injection for PDT (JI-PDT) for BCC treatment.

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/lsm.23793

Jet‐injection assisted photodynamic therapy for superficial ... This prospective open-label pilot trial investigated the safety and efficacy of photosensitizer jet injection for PDT (JI-PDT) for BCC treatment.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38804170/

Jet-injection assisted photodynamic therapy for superficial and ... Jet injection of ALA for PDT treatment of nodular low-risk BCC is tolerable and feasible and may represent a novel modality to improve PDT.

4. researchgate.net researchgate.net/publication/380930740_Jet-injection_assisted_photodynamic_therapy_for_superficial_and_nodular_basal_cell_carcinoma_A_pilot_study

Jet-injection assisted photodynamic therapy for superficial ... The median composite LSR score immediately after JI‐PDT was 5 (interquartile range [IQR] = 3) which decreased to 0.5 (IQR = 1) at primary endpoint ( p < 0.01).

5. europepmc.org europepmc.org/article/med/40419100

5-aminolevulinic acid photodynamic therapy for the ... This review provides a comprehensive summary of evidence-based ALA-PDT protocols for BCC, BD, and SCC, but published protocols are heterogeneous without a clear ...

6. jaad.org jaad.org/article/S0190-9622(24)02019-X/fulltext

49988 Jet-Injection Assisted Photodynamic Therapy for ... Average patient satisfaction score was 9.4/10. The unique usage of jet injection for PDT treatment for BCC is safe and tolerable for patients and may represent ...

7. jaad.org jaad.org/article/S0190-9622(24)02019-X/pdf

49988 Jet-Injection Assisted Photodynamic Therapy for ... The unique usage of jet injection for PDT treatment for BCC is safe and tolerable for patients and may represent a novel modality to improve PDT for deeper ...