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Non-melanoma Skin CancerNCT04103658

NIR and Skin Cancer Margins

A study testing Near-infrared heating in people with Non-melanoma Skin Cancer, run by Western University, Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Non-melanoma Skin Cancer
What is being tested?
Near-infrared heating
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
30 Sep 2019to 30 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Prior radiation therapy or photodynamic therapy to the area with the NMSC lesion
  • Patients with a history of cutaneous photosensitization
  • Unable to consent

Trial locations and contacts

No sites are listed yet.

About this study

Official title: Near-infrared Heating of Skin to Delineate Non-melanoma Skin Cancer Lesions: a Pilot Study.

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.

Read the detailed description

Non-melanoma skin cancer (NMSC) is the most common cancer diagnosis in Canada, and its incidence is still increasing. Visual examination followed by biopsies of suspicious lesions are the gold standard for skin cancer diagnosis. The mainstays of treatment include photodynamic therapy, radiation therapy, and surgical excision. The margins of NMSC lesions are typically determined via visual inspection, and excised based on delineating normal from abnormal tissue. According to the National Comprehensive Cancer Network, low-risk basal cell cancers should be excised with a 4mm margin; squamous cell skin cancers and high-risk basal cell cancers should be excised with 4-6mm margins, as per the National Comprehensive Cancer Network. These lesions frequently occur on cosmetically sensitive areas of the head and neck, therefore accurate margins and excision can help to preserve the overall appearance. Accurate lesion delineation with proper margins can also reduce the need for further treatment if the margins are positive. In approximately 2-3% of cases at our centre, the margins are positive.

Near-infrared radiation (NIR) represents the light spectrum from 0.7 to 1.5 micrometers. At the shorter wavelengths, it merges with the red spectrum of visible light. These forms of light have the ability to heat the skin up to a 5 mm depth. Previous studies have examined the relationship between skin blood flow and temperature when heating skin, where dermal temperature can reach a certain peak in a defined time. Other studies have investigated the application of NIR when combined with photo immunotherapy, as a means of treating other cancers. More elaborate multispectral analysis devices have been studied for their effectiveness in diagnosing cutaneous malignancies. NIR application is well tolerated, in past studies.The objective of this study is to determine if the vasculature of normal skin and NMSC skin appears differently following heating with NIR light, and if this difference corresponds to better margin delineation.

The excisions and reconstructions are all within the standard of care. The only added testing will be application of near-infrared heat via a heating lamp to the lesional skin, for a total of ten minutes. Each patient will have their skin cancer lesion photographed, and traced onto acetate film. The NIR heating will then occur under a lamp for a total of ten minutes at a distance of 20cm. At the end of the ten minutes, the lesion and its borders will again be traced onto a separate acetate film. Using Excel for block randomization, patients will then be randomized to excision with the non-heated versus heated margins. The allocation will not be known until the moment of assignment. The excisions will then occur in the same fashion between the two groups, and all specimens will be submitted for pathology, as is standard of care.

Data will be recorded for various patient and lesions factors that may potentially influence the outcome of NIR heating therapy. These include age and gender, lesion size and location, and history of skin disorders. The lesion size and final pathology, with quantitative margin distances, will be recorded. Statistical analysis will be performed to determine if there is an overall difference in qualitative (negative or positive) and quantitative margin status between those lesions excised under standard procedure vs. NIR heating.

Being tested
Near-infrared heating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Near-infrared heatingRadiation

    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.

Study groups in NCT04103658
Study groupRoleWhat they receive
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 heatingExperimentalThis 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).
Receives: Radiation: Near-infrared heating

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Margin status

    Difference in margin status between the control and the near-infrared heating group.

    Measured: 3 months

Secondary outcomes (1)
  1. Skin vascularity changes

    Visual changes in the vasculature of normal skin and NMSC skin following application or NIR light.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2019
  2. Study start30 Sep 2019 (estimated)
  3. Primary completion30 Dec 2019 (estimated)
  4. Study completion30 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04103658
Sponsor's protocol ID
114153
Status last verified
Sep 2019
First submitted
23 Sep 2019
Last updated
25 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Near-infrared heating in people with Non-melanoma Skin Cancer, run by Western University, Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kiersten Pianosi, MD (519-685-8500 ext. 18074, kpianosi@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Margin status (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.

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