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

Basal Cell Carcinoma Clinical Trial

Official title:

Jet-Injection Assisted Photodynamic Therapy for Basal Cell Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04552990
• Other study ID #: 20-270
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 9, 2020
• Est. completion date: September 9, 2024

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: September 9, 2024
• Est. primary completion date: September 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Basal Cell Cancer
• Basal Cell Carcinoma
• BCC
• BCC - Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Neoplasms, Basal Cell
• Nodular Basal Cell Carcinoma
• Superficial Basal Cell Carcinoma

Intervention

Drug:
• 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).

Procedure:
• 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).

Other:
• Incubation
After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical evaluation of local skin responses on Day 0	Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 0 (PDT treatment #1)	Day 1
Primary	Clinical evaluation of local skin responses on Day 3	Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 3	Day 3
Primary	Clinical evaluation of local skin responses on Day 14	Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 14 (PDT treatment #2)	Day 14
Primary	Clinical evaluation of local skin responses on Day 17	Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 17	Day 17
Primary	Clinical evaluation of local skin responses 3 months post treatment	Clinical evaluation of local skin responses on a 0-4 point scale will be performed 3 months post treatment	3 months after treatment

External Links

•   Memorial Sloan Kettering Cancer Center