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The purpose of this study is to find out whether injecting ALA into the skin with a jet-injection device and activating the drug with light is a safe treatment that causes few or mild side effects in people with basal cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumor Excision, No Illumination | Experimental | 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. |
|
| PDT treatment with jet-injections | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jet injection of ALA | Drug | The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap). |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Evaluation of Local Skin Responses on Day 0 | Clinical evaluation of local skin responses will be performed at Day 0 (PDT treatment #1). The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity). | Baseline (Day 0) |
| Clinical Evaluation of Local Skin Responses on Day 3 | Clinical evaluation of local skin responses will be performed at Day 3. The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity). | Day 3 |
| Clinical Evaluation of Local Skin Responses on Day 14 | Clinical evaluation of local skin responses will be performed at Day 14 (PDT treatment #2). The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity). | Day 14 |
| Clinical Evaluation of Local Skin Responses on Day 17 | Clinical evaluation of local skin responses will be performed at Day 17. The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity). | Day 17 |
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Inclusion Criteria:
Subjects who meet all of the following criteria are eligible to participate in this study
Exclusion Criteria:
Subjects meeting any one of the following criteria are not eligible to participate in this study
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Rossi, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tumor Excision, No Illumination | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2022 |
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| Surgical excision | Procedure | In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted). |
|
| Illumination | Procedure | For patients 5-16,after 3h incubation (+/- 30 min), the tumor will be illuminated with red light corresponding to a dose of 75 J/cm2 570- 670 nm or equivalent dose of narrowband red light. The intervention will be repeated at after 14 days in patient 5-16. If the wound is not healed at two weeks, the treatment may be postponed to allow healing (patient 5-16). |
|
| Incubation | Other | After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min). |
|
| Clinical Evaluation of Local Skin Responses 3 Months Post Treatment |
Clinical evaluation of local skin responses will be performed 3 months post treatment. The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity). |
| 3 months after treatment |
| PDT Treatment With Jet-injections |
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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tumor Excision, No Illumination | 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. |
| BG001 | PDT Treatment With Jet-injections | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Evaluation of Local Skin Responses on Day 0 | Clinical evaluation of local skin responses will be performed at Day 0 (PDT treatment #1). The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity). | PDT treatment arm only due to participants receiving Illumination as part of treatment regimen. The Tumor Excision, No Illumination cohort's purpose was only to assess biodistribution of ALA through fluorescence microscopy. | Posted | Mean | Inter-Quartile Range | score on a scale | Baseline (Day 0) |
|
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| ||||||||||||||||||||||||||||||||||||||
| Primary | Clinical Evaluation of Local Skin Responses on Day 3 | Clinical evaluation of local skin responses will be performed at Day 3. The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity). | PDT treatment arm only due to participants receiving Illumination as part of treatment regimen. The Tumor Excision, No Illumination cohort's purpose was only to assess biodistribution of ALA through fluorescence microscopy. | Posted | Mean | Inter-Quartile Range | score on a scale | Day 3 |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Clinical Evaluation of Local Skin Responses on Day 14 | Clinical evaluation of local skin responses will be performed at Day 14 (PDT treatment #2). The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity). | PDT treatment arm only due to participants receiving Illumination as part of treatment regimen. The Tumor Excision, No Illumination cohort's purpose was only to assess biodistribution of ALA through fluorescence microscopy. | Posted | Mean | Inter-Quartile Range | score on a scale | Day 14 |
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| Primary | Clinical Evaluation of Local Skin Responses on Day 17 | Clinical evaluation of local skin responses will be performed at Day 17. The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity). | PDT treatment arm only due to participants receiving Illumination as part of treatment regimen. The Tumor Excision, No Illumination cohort's purpose was only to assess biodistribution of ALA through fluorescence microscopy. | Posted | Mean | Inter-Quartile Range | score on a scale | Day 17 |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Clinical Evaluation of Local Skin Responses 3 Months Post Treatment | Clinical evaluation of local skin responses will be performed 3 months post treatment. The LSR/Local Skin Responses Grading Scale is an objective tool allowing practicing dermatologists to characterize and compare LSRs to existing and, potentially, future therapies. Characteristics of skin responses are identified and allocated a numeric grade of severity (0-4, with 4 being the highest grade of severity). | PDT treatment arm only due to participants receiving Illumination as part of treatment regimen. The Tumor Excision, No Illumination cohort's purpose was only to assess biodistribution of ALA through fluorescence microscopy. | Posted | Mean | Inter-Quartile Range | score on a scale | 3 months after treatment |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tumor Excision, No Illumination | 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. Jet injection of ALA: The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap). Surgical excision: In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted). Incubation: After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min). | 0 | 4 | 0 | 4 | 0 | 4 |
| EG001 | PDT Treatment With Jet-injections | 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. Jet injection of ALA: The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap). Surgical excision: In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted). Illumination: For patients 5-16,after 3h incubation (+/- 30 min), the tumor will be illuminated with red light corresponding to a dose of 75 J/cm2 570- 670 nm or equivalent dose of narrowband red light. The intervention will be repeated at after 14 days in patient 5-16. If the wound is not healed at two weeks, the treatment may be postponed to allow healing (patient 5-16). Incubation: After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min). | 0 | 12 | 1 | 12 | 1 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infections and infestations - Other, specify | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anthony Rossi, MD | Memorial Sloan Kettering Cancer Center | 646-608-3982 | rossia@mskcc.org |
| Feb 16, 2026 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| D018295 | Neoplasms, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008029 | Lighting |
| D055256 | Infectious Disease Incubation Period |
| ID | Term |
|---|---|
| D004780 | Environment, Controlled |
| D004777 | Environment |
| D004778 | Environment and Public Health |
| D018562 | Disease Transmission, Infectious |
| D011634 | Public Health |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Crusting |
|
| Pustulation |
|
| Erosion/Ulceration |
|
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. Jet injection of ALA: The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap). Surgical excision: In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted). Illumination: For patients 5-16,after 3h incubation (+/- 30 min), the tumor will be illuminated with red light corresponding to a dose of 75 J/cm2 570- 670 nm or equivalent dose of narrowband red light. The intervention will be repeated at after 14 days in patient 5-16. If the wound is not healed at two weeks, the treatment may be postponed to allow healing (patient 5-16). Incubation: After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min). |
|
|
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. Jet injection of ALA: The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap). Surgical excision: In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted). Illumination: For patients 5-16,after 3h incubation (+/- 30 min), the tumor will be illuminated with red light corresponding to a dose of 75 J/cm2 570- 670 nm or equivalent dose of narrowband red light. The intervention will be repeated at after 14 days in patient 5-16. If the wound is not healed at two weeks, the treatment may be postponed to allow healing (patient 5-16). Incubation: After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min). |
|
|
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. Jet injection of ALA: The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap). Surgical excision: In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted). Illumination: For patients 5-16,after 3h incubation (+/- 30 min), the tumor will be illuminated with red light corresponding to a dose of 75 J/cm2 570- 670 nm or equivalent dose of narrowband red light. The intervention will be repeated at after 14 days in patient 5-16. If the wound is not healed at two weeks, the treatment may be postponed to allow healing (patient 5-16). Incubation: After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min). |
|
|
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. Jet injection of ALA: The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap). Surgical excision: In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted). Illumination: For patients 5-16,after 3h incubation (+/- 30 min), the tumor will be illuminated with red light corresponding to a dose of 75 J/cm2 570- 670 nm or equivalent dose of narrowband red light. The intervention will be repeated at after 14 days in patient 5-16. If the wound is not healed at two weeks, the treatment may be postponed to allow healing (patient 5-16). Incubation: After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min). |
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