NCT04480645

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
3.8 years until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

July 16, 2020

Last Update Submit

March 20, 2026

Conditions

Squamous Cell Carcinoma of the SkinBasal Cell Carcinoma

Keywords

radiationbrachytherapyskin cancer

Outcome Measures

Primary Outcomes (1)

  • skin toxicity events

    grade 3+ events

    within 2 months of treatment

Secondary Outcomes (1)

  • dose delivered to target

    1 week

Study Arms (1)

Treatment

EXPERIMENTAL

Radioactive bandage applied to surface of the body worn for approximately one week.

Device: CivaDerm

Interventions

CivaDermDEVICE

radioactive bandage

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Is unable or unwilling to comply with the protocol requirements
  • Pregnant or breast feeding
  • Metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CivaDerm Oncology PLLC

Morrisville, North Carolina, 27560, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal CellSkin Neoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single arm pilot study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2020

First Posted

July 21, 2020

Study Start

May 1, 2024

Primary Completion

December 1, 2025

Study Completion

January 30, 2026

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)