Pilot study of a new brachytherapy device for skin cancer treatment
CivaDerm(TM) Surface Therapy Pilot Study
This study is testing a new device that delivers targeted radiation therapy for treating certain types of skin cancer to see if it works better than current methods.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CivaTech Oncology Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Morrisville, North Carolina) |
| Trial ID | NCT04480645 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effectiveness of the CivaDerm device, which uses palladium-103 for brachytherapy, in treating patients with superficial or nodular basal cell carcinoma and squamous cell carcinoma. The device aims to deliver conformal radiation therapy specifically to the surface of the skin, potentially improving treatment outcomes. Participants will be monitored for their response to this novel approach, which may offer a new option for patients with specific tumor characteristics.
Who should consider this trial
Good fit: Ideal candidates are adults with confirmed superficial or nodular basal cell or squamous cell carcinoma located on the trunk or extremities, with specific tumor size and residual tumor requirements.
Not a fit: Patients with metastatic disease, those who are pregnant or breastfeeding, or individuals unable to comply with the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and targeted radiation therapy option for patients with skin cancer.
How similar studies have performed: While this approach is novel, similar studies using brachytherapy for skin cancer have shown promising results in the past.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Morrisville, North Carolina
- CivaDerm Oncology PLLC — Morrisville, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Kristy Perez, PhD
- Email: kperez@civatechoncology.com
- Phone: 9193145515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.