NIR and Skin Cancer Margins
Near-infrared Heating of Skin to Delineate Non-melanoma Skin Cancer Lesions: a Pilot Study.
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
We aim to determine whether the application of near-infrared radiation via standard heat lamp to non-melanoma skin lesions (such as basal cell carcinomas) before surgical excision is able to better delineate the lesion and surgical margins. If found to do so, pre-heating of skin lesions could lead to more specimens with negative margins. Patients presenting to the tertiary care centre skin cancer clinic for excision of skin cancer will be approached and offered to participate in the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2019
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2019
CompletedFirst Posted
Study publicly available on registry
September 25, 2019
CompletedStudy Start
First participant enrolled
September 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedSeptember 25, 2019
September 1, 2019
3 months
September 23, 2019
September 23, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Margin status
Difference in margin status between the control and the near-infrared heating group.
3 months
Secondary Outcomes (1)
Skin vascularity changes
3 months
Study Arms (2)
Standard of care (control)
NO INTERVENTIONThis will be the standard of care group. The excision of the non-melanoma skin cancer will be based on standard visual inspection with 4-6mm margins.
NIR heating
EXPERIMENTALThis will be the NIR heating group, where the excision of the non-melanoma skin cancer will be based on the lesion margins based on the application of near-infrared radiation (with 4-6mm margins).
Interventions
Same as the arm/group description. The NIR heating group will have the non-melanoma skin cancer lesion excised based on the lesion borders established from application of NIR heat at a distance of 20cm for 10 minutes.
Eligibility Criteria
You may qualify if:
- The patient population includes individuals with a nonmelanotic cervicofacial cutaneous malignancy referred to a tertiary care skin cancer clinic for definitive treatment. Patients must have:
- Histologically confirmed nonmelanotic cutaneous malignancies, either basal cell or squamous cell carcinoma
- No prior treatment with investigational agents
- Ability to tolerate intended treatment Patient's age is greater than or equal to 18 years
You may not qualify if:
- Prior radiation therapy or photodynamic therapy to the area with the NMSC lesion
- Patients with a history of cutaneous photosensitization
- Unable to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Patients will be randomly assigned to the group of excision without or with near-infrared heat. Both the patient and investigator will be aware of the group allocation prior to the definitive excision.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 23, 2019
First Posted
September 25, 2019
Study Start
September 30, 2019
Primary Completion
December 30, 2019
Study Completion
December 30, 2019
Last Updated
September 25, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share