BCCPhase 2NCT04552990

Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma

A Phase 2 study testing Jet injection of ALA, Surgical excision and Illumination in people with BCC and BCC - Basal Cell Carcinoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: BCC, BCC - Basal Cell Carcinoma, Basal Cell Carcinoma
What is being tested?: Jet injection of ALA, Surgical excision and Illumination
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 9 Sep 2020to 4 Apr 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects who meet all of the following criteria are eligible to participate in this study
Histologically-verified, previously untreated low-risk mixed superficial and nodular BCC(s) or nodular BCC(s) < 1 cm in diameter on scalp, extremities, or trunk.
≥ 18 years of age
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
Being able to take pictures of their treated BCC(s) (with or without assistance)

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Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment. (Female subjects are considered of childbearing potential unless they have been hysterectomized or have undergone tubal ligation or have been post-menopausal for at least one year prior to the first visit)
Legally competent, able to give verbal and written informed consent
Subject in good general health and willing to participate comply with protocol requirements.
Superficial and nodular BCC(s)

Who cannot join

Subjects meeting any one of the following criteria are not eligible to participate in this study
High-risk BCC(s) (H area, >1 cm in M area, or >2 cm in L area)
BCC(s) subtype morpheaform
Diagnosed with gorlin syndrome
Receiving immunosuppressive medication
Subjects with a known allergy to ALA

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Individuals with other interfering skin diseases in the area of treatment
Subjects with a tattoo in the treatment area which may interfere with or confound the evaluation of the study
Subjects with a history of keloids which is deemed clinically relevant in the opinion of the investigator
Lactating or pregnant women
Patient who are taking prescription pain medications or can not stop OTC pain medications.

Trial locations and contacts

1 site in 1 country.

United States1 site

Memorial Sloan Kettering Cancer Center
New York, New York, 10065

Other trials in United States

About this study

Official title: Jet-Injection Assisted Photodynamic Therapy for Basal Cell Carcinoma

Conditions: BCC, BCC - Basal Cell Carcinoma, Basal Cell Carcinoma, Basal Cell Cancer, Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma
Being tested: Jet injection of ALA, Surgical excision, Illumination, Incubation
Keywords: Superficial BBC, Nodular BBC, Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma, BCC, Basal Cell Carcinoma, PDT treatment, photodynamic therapy, Jet injection, Memorial Sloan Kettering Cancer Center, 20-270
Medical subject headings: Carcinoma, Basal Cell, Neoplasms, Basal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Jet injection of ALADrug
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 excisionProcedure or surgery
In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted).
IlluminationProcedure or surgery
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).
IncubationOther
After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).

Study groups in NCT04552990
Study group	Role	What they receive
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. Receives: Drug: Jet injection of ALA; Procedure: Surgical excision; Other: Incubation
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. Receives: Drug: Jet injection of ALA; Procedure: Surgical excision; Procedure: Illumination; Other: Incubation

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Day 17
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).
Measured: 3 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Sep 20204 Apr 2025

First posted17 Sep 2020
Study start9 Sep 2020
Primary completion4 Apr 2025
Study completion4 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for BCCStudies of the same condition, open and under way.
More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04552990
Sponsor's protocol ID: 20-270
Status last verified: Apr 2025
First submitted: 10 Sep 2020
Last updated: 18 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Jet-Injection Assisted Photodynamic Therapy for Basal Cell Carcinoma
ClinicalTrials.gov ID: NCT04552990
Acronym / sponsor ID: 20-270
Conditions: BCC, BCC - Basal Cell Carcinoma, Basal Cell Carcinoma, Basal Cell Cancer, Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma
Keywords: Superficial BBC, Nodular BBC, Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma, BCC, Basal Cell Carcinoma, PDT treatment, photodynamic therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
Study start: 9 Sep 2020 (actual)
Primary completion: 4 Apr 2025 (actual)
Study completion: 4 Apr 2025 (actual)
First posted: 17 Sep 2020 (actual)
Results: Posted 18 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Tumor Excision, No Illumination	Experimental	Drug: Jet injection of ALA, Procedure: Surgical excision, Other: IncubationThe 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	Drug: Jet injection of ALA, Procedure: Surgical excision, Procedure: Illumination, Other: IncubationPatient 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 may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Subjects who meet all of the following criteria are eligible to participate in this study
Histologically-verified, previously untreated low-risk mixed superficial and nodular BCC(s) or nodular BCC(s) < 1 cm in diameter on scalp, extremities, or trunk.
≥ 18 years of age
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

Key exclusion criteria (11 listed)

Subjects meeting any one of the following criteria are not eligible to participate in this study
High-risk BCC(s) (H area, >1 cm in M area, or >2 cm in L area)
BCC(s) subtype morpheaform
Diagnosed with gorlin syndrome
Receiving immunosuppressive medication

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Jet injection of ALAThe 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).	Drug	PDT treatment with jet-injections, Tumor Excision, No Illumination
Surgical excisionIn the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted).	Procedure or surgery	PDT treatment with jet-injections, Tumor Excision, No Illumination
IlluminationFor 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).	Procedure or surgery	PDT treatment with jet-injections
IncubationAfter injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).	Other	PDT treatment with jet-injections, Tumor Excision, No Illumination

Primary outcome

Clinical Evaluation of Local Skin Responses on Day 0
Time frame: Baseline (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).
Clinical Evaluation of Local Skin Responses on Day 3
Time frame: 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).
Clinical Evaluation of Local Skin Responses on Day 14
Time frame: 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).
Clinical Evaluation of Local Skin Responses on Day 17
Time frame: 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).
Clinical Evaluation of Local Skin Responses 3 Months Post Treatment
Time frame: 3 months after 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).

Results and safety

Results posted to the registry on 18 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tumor Excision, No Illumination	4	4
PDT Treatment With Jet-injections	12	11

Primary outcome: Clinical Evaluation of Local Skin Responses on Day 0

Time frame: Baseline (Day 0). Mean (Inter-Quartile Range). Unit: score on a scale

Measure	Tumor Excision, No Illumination n = 0	PDT Treatment With Jet-injections n = 12
Erythema	–	2 (0 to 2)
Edema	–	1 (0 to 1)
Flaking	–	0 (0 to 1)
Crusting	–	0 (0 to 1)
Pustulation	–	1 (0 to 1)
Erosion/Ulceration	–	1 (0 to 1)

Population analysed: 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.

Primary outcome: Clinical Evaluation of Local Skin Responses on Day 3

Time frame: Day 3. Mean (Inter-Quartile Range). Unit: score on a scale

Measure	Tumor Excision, No Illumination n = 0	PDT Treatment With Jet-injections n = 12
Erythema	–	2 (1 to 2)
Edema	–	1 (0 to 1)
Flaking	–	1 (1 to 1)
Crusting	–	1 (1 to 1)
Pustulation	–	0 (0 to 0)
Erosion/Ulceration	–	0 (0 to 1)

Primary outcome: Clinical Evaluation of Local Skin Responses on Day 14

Time frame: Day 14. Mean (Inter-Quartile Range). Unit: score on a scale

Measure	Tumor Excision, No Illumination n = 0	PDT Treatment With Jet-injections n = 12
Erythema	–	2 (1 to 2)
Edema	–	1 (0 to 1)
Flaking	–	0 (0 to 1)
Crusting	–	1 (0 to 1)
Pustulation	–	0 (0 to 0)
Erosion/Ulceration	–	0 (0 to 0)

Primary outcome: Clinical Evaluation of Local Skin Responses on Day 17

Time frame: Day 17. Mean (Inter-Quartile Range). Unit: score on a scale

Measure	Tumor Excision, No Illumination n = 0	PDT Treatment With Jet-injections n = 12
Erythema	–	2 (1 to 2)
Edema	–	1 (0 to 1)
Flaking	–	1 (0 to 1)
Crusting	–	0 (0 to 1)
Pustulation	–	0 (0 to 1)
Erosion/Ulceration	–	0 (0 to 0)

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tumor Excision, No Illumination	0 of 4 (0%)	0 of 4 (0%)	0 of 4
PDT Treatment With Jet-injections	1 of 12 (8.3%)	1 of 12 (8.3%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anthony Rossi, MD principal investigator

Memorial Sloan Kettering Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Evaluation of Local Skin Responses on Day 0 (time frame: Baseline (Day 0)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04552990.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.