Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma
NCT ID: NCT04552990
Last Updated: 2025-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
16 participants
INTERVENTIONAL
2020-09-09
2025-04-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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)
Exclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Anthony Rossi, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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20-270
Identifier Type: -
Identifier Source: org_study_id
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