Back to resultsCivaDerm(TM) Surface Therapy Pilot Study
Primary Purpose
Basal Cell Carcinoma, Squamous Cell Carcinoma of the Skin
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
CivaDerm
Sponsored by
About this trial
This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring radiation, brachytherapy, skin cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Radioactive bandage applied to surface of the body worn for approximately one week.
Outcomes
Primary Outcome Measures
skin toxicity events
grade 3+ events
Secondary Outcome Measures
dose delivered to target
calculated radiation dose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04480645
Brief Title
CivaDerm(TM) Surface Therapy Pilot Study
Official Title
CivaDerm(TM) Surface Therapy Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CivaTech Oncology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma, Squamous Cell Carcinoma of the Skin
Keywords
radiation, brachytherapy, skin cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Single arm pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Radioactive bandage applied to surface of the body worn for approximately one week.
Intervention Type
Device
Intervention Name(s)
CivaDerm
Intervention Description
radioactive bandage
Primary Outcome Measure Information:
Title
skin toxicity events
Description
grade 3+ events
Time Frame
within 2 months of treatment
Secondary Outcome Measure Information:
Title
dose delivered to target
Description
calculated radiation dose
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristy Perez, PhD
Phone
9193145515
Email
kperez@civatechoncology.com
First Name & Middle Initial & Last Name or Official Title & Degree
Carra Castagnero
Phone
9193145515
Email
clinical@civatechoncology.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CivaDerm(TM) Surface Therapy Pilot Study
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