Clinical trial NCT04552990: Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma
Official title: Jet-Injection Assisted Photodynamic Therapy for Basal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Jet injection
Memorial Sloan Kettering Cancer Center
20-270
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

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)
* 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:

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
* 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.

Primary outcomes:
measure: Clinical evaluation of local skin responses on Day 0
timeFrame: Day 1
measure: Clinical evaluation of local skin responses on Day 3
timeFrame: Day 3
measure: Clinical evaluation of local skin responses on Day 14
timeFrame: Day 14
measure: Clinical evaluation of local skin responses on Day 17
timeFrame: Day 17
measure: Clinical evaluation of local skin responses 3 months post treatment
timeFrame: 3 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Anthony Rossi, MD
role: PRINCIPAL_INVESTIGATOR
References: