Clinical Trials Logo
  1. Home
  2. Basal Cell Carcinoma
  3. NCT04480645
  4. Details
NCT04480645 Clinical Trial

CivaDerm(TM) Surface Therapy Pilot Study

Basal Cell Carcinoma Clinical Trial

Official title:
CivaDerm(TM) Surface Therapy Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04480645
Other study ID # CT008
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date October 1, 2022
Est. completion date April 30, 2023

Study information
Verified date July 2022
Source CivaTech Oncology
Contact Kristy Perez, PhD
Phone 9193145515
Email kperez@civatechoncology.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a pilot study to determine the usefulness of new brachytherapy device that utilizes active components (palladium-103) of standard devices in a novel configuration, which may benefit basal cell and squamous cell carcinoma patients by providing conformal radiation therapy to the surface of the skin.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10
Est. completion date April 30, 2023
Est. primary completion date February 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - subject signed informed consent - Confirmed superficial or nodular basal cell or squamous cell carcinoma - Biopsy proven on chest, stomach, back, arms, legs, feet (trunk and extremities) - >5 mm of residual tumor - tumors < 3 cm - Capable of complying with Patient Release Instructions Exclusion Criteria: - Is unable or unwilling to comply with the protocol requirements - Pregnant or breast feeding - Metastases

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CivaDerm
radioactive bandage

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
CivaTech Oncology

Outcome
Type Measure Description Time frame Safety issue
Primary skin toxicity events grade 3+ events within 2 months of treatment
Secondary dose delivered to target calculated radiation dose 1 week
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04552990 - Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma Phase 2
Completed NCT04229277 - Fast Track Diagnosis of Skin Cancer by Advanced Imaging N/A
Completed NCT05608902 - Structural Description of Skin Biopsies With Dynamic Full-field Optical Coherence Tomography on Suspected Basal Cell Carcinoma Lesions, a Pilot Study (DOCTOBA)
Completed NCT05077033 - Intratumoral phIL12 GET Phase 1
Active, not recruiting NCT04928222 - Placebo Microneedles in Healthy Volunteers (Part I) and Efficacy/Safety of Doxorubicin Microneedles in Basal Cell Cancer Subjects (Part II) Phase 1/Phase 2
Recruiting NCT04929535 - Hydrogen Peroxide Trial to Investigate the Efficacy of 30%H2O2 as a Topical Application Before Definitive Treatment Phase 2
Completed NCT02662244 - Long-pulsed 1064 nm Nd:YAG Laser Treatment of Basal Cell Carcinoma N/A
Completed NCT00959647 - A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study Phase 2
Completed NCT00793169 - Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery
Completed NCT00586040 - Photochemical Tissue Bonding Phase 2
Completed NCT00473343 - Metvix PDT in Participant With "High Risk" Basal Cell Carcinoma Phase 3
Active, not recruiting NCT06024629 - cOCT Versus LC-OCT for Diagnosing Basal Cell Carcinoma: a Diagnostic Cohort Study
Not yet recruiting NCT05324202 - New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management N/A
Withdrawn NCT04099446 - A Non-Interventional Pilot Study to Explore the Skin Microbes in Skin Cancer
Completed NCT02902822 - Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo N/A
Completed NCT01208831 - An East Asian Study of LDE225 Phase 1
Completed NCT01260987 - Fractional CO2 Laser Assisted Photodynamic Therapy Phase 2/Phase 3
Completed NCT01201915 - A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) in Operable Basal Cell Carcinoma Phase 2
Completed NCT01014819 - A Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions N/A
Completed NCT00472043 - PDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Patients With Primary Nodular Basal Call Carcinoma Phase 3