MedTrace Logo

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

NCT04552990 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-04-23

No results posted yet for this study

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.

Conditions

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

Interventions

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).

PROCEDURE

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).

Sponsors & Collaborators

Principal Investigators

  • Anthony Rossi, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-09
Primary Completion
2025-04-04
Completion
2025-04-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04552990 on ClinicalTrials.gov