Skin CancerNCT03069846
Diagnosing Melanoma, Squamous Cell Carcinoma and Basal Cell Carcinoma Using the Spectra-Scope
A study testing Spectra-Scope in people with Skin Cancer, run by Sung Hyun Pyun at 1 site in Australia.
Trial summary
The primary objective is to collect emission spectra of normal tissue, pigmented normal lesion, benign lesion, SCC, BCC and melanoma to construct the database and validate the classifying algorithm. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Spectra-Scope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Jun 2017to 18 Jun 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be aged 18 years or over;
- Have at least one suspicious lesion that:
- Is required to be biopsied for assessment of skin cancer (as assessed by at least one dermatologist);
- Has a diameter of more than 2 mm but less than 22 mm;
- Is accessible to the Spectra-Scope device;
- Provide written informed consent.
Who cannot join
- Have a known allergy to ethanol;
- Have a lesion that:
- Has previously been biopsied, excised or traumatised;
- Is not intact;
- Is within 1 cm of the eye;
- Is on a mucosal surface (lips, genitals);
Show all 14Show fewer
- Is on palmar hands;
- Is on palmar feet;
- Is on or under nails;
- Is located on or in an area of visible scarring;
- Contains foreign matter (tattoo, splinter, marker)
- Have an active infection;
- Have an open lesion sampled;
- Have an autoimmune disease such as lupus or scleroderma vitiligo.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Integrated Specialist Healthcare
Miranda, New South Wales, 2228
Nicholas Vasudeva, 61447656384, nicholas.vasudeva@ishc.com.au
Saleem Loghdey, M.D.
About this study
Official title: Collecting Spectral Signatures of Melanoma, Squamous Cell Carcinoma, Basal Cell Carcinoma, Benign Lesions and Normal Tissues Using Spectra-Scope
The primary objective is to collect emission spectra of normal tissue, pigmented normal lesion, benign lesion, SCC, BCC and melanoma to construct the database and validate the classifying algorithm.
Read the detailed description
The Speclipse Spectra-Scope consists of the light collection module and the spectral analysis module. The light collection module is attached to the handpiece of short pulse (a few nanoseconds) Nd:YAG (neodymium-doped yttrium aluminium garnet) commercial cosmetic laser, and the analysis module is placed on the laser. When Nd:YAG laser is irradiated onto the skin lesion, the laser ablates a trace amount of tissue, producing micro plasma. The emitted light from the micro plasma is analysed spectrally to determine the elemental and molecular information from the tissue in real time. No calibration of the Spectra-Scope is required.
Before the skin is irradiated with the laser, select the age, sex and the position of the target skin lesion and put the patient number of the day on the software panel of laptop which is connected to the device. Prior to sampling, the skin site must be wiped with ethanol and allowed to air dry. When the laser is irradiated, the emission spectra of tissue is automatically generated from the spectrometer inside the device and simultaneously displayed on the monitor, and stored in the laptop. The spectral data stored in the laptop is wirelessly accessible using Google drive.
An algorithm then determines whether the skin is from a normal, pigmented normal, benign, squamous cell carcinoma (SCC), basal cell carcinoma (BCC) or melanoma based on the spectral 'signature'. These algorithms have been determined during clinical ex-vivo and in-vivo studies performed in Korea. The purpose of this study is to collect tissue emission spectra of Australian patients and to further refine the algorithms, and to confirm the appropriate spectra for 'normal', 'benign', 'melanoma', 'SCC', and 'BCC'.
Each potential skin cancer site, which has previously been identified as requiring biopsy, is assessed using five laser shots that last approximately 10 milliseconds per shot and measurement. The laser shots are made before the scheduled biopsy.
Some of the potential skin cancer sites will be labelled as cancers ('melanoma', 'SCC' or 'BCC') from the biopsy result, and some of the potential skin cancer site will be labelled as 'benign' (control group 1) from the biopsy result.
- Conditions
- Skin Cancer
- Being tested
- Spectra-Scope
- Keywords
- skin cancer, laser spectroscopy, non-invasive diagnostics
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectra-ScopeDevice
The Spectra-Scope consists of the light collection module and the spectral analysis module.
The light collection module is attached to the handpiece of short pulse Nd:YAG laser, and the analysis module is placed on the laser.
Each potential skin cancer site, which has previously been identified as requiring biopsy, should be assessed using five laser shots that last approximately 10 milliseconds per shot and measurement. The laser shots must be made before the scheduled biopsy.
All potentially cancerous lesions (or lesions that would usually undergo complete biopsy of the lesion or require follow up within three months) should be sampled. The Spectra-Scope will not provide a diagnosis at the time of sampling. Sites should record the spectra reported for each laser shot in the CRF.
| Study group | Role | What they receive |
|---|---|---|
| Measurement using Spectra-Scope | Experimental | Short pulsed Nd:YAG laser irradiation onto the skin lesion / measurement with Spectra-Scope Receives: Device: Spectra-Scope |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is to compare the aggregated emission spectra of skin cell carcinoma verses normal skin.
The aggregated emission spectra collected over a range of wavelengths from skin cells (skin cancer verses normal skin) irradiated with a commercial laser will be plotted to identify wavelengths with greatest spectra seperation.
Measured: We plan to recruit 150 patients within a 3 month time frame.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start5 Jun 2017
- Primary completion18 Jun 2018 (estimated)
- Study completion18 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sung Hyun Pyun
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Sung Hyun Pyun, Speclipse Australia Pty Ltd
- Investigators
- Saleem Loghdey, M.D., Principal investigator, Integrated Specialist Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069846
- Sponsor's protocol ID
- Speclipse-2016-10
- Status last verified
- Apr 2018
- First submitted
- 20 Feb 2017
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collecting Spectral Signatures of Melanoma, Squamous Cell Carcinoma, Basal Cell Carcinoma, Benign Lesions and Normal Tissues Using Spectra-Scope
- ClinicalTrials.gov ID
- NCT03069846
- Acronym / sponsor ID
- Speclipse-2016-10
- Conditions
- Skin Cancer
- Keywords
- skin cancer, laser spectroscopy, non-invasive diagnostics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sung Hyun PyunIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 18 Jun 2018 (estimated)
- Study completion
- 18 Jun 2018 (estimated)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to collect emission spectra of normal tissue, pigmented normal lesion, benign lesion, SCC, BCC and melanoma to construct the database and validate the classifying algorithm.
Detailed description
The Speclipse Spectra-Scope consists of the light collection module and the spectral analysis module. The light collection module is attached to the handpiece of short pulse (a few nanoseconds) Nd:YAG (neodymium-doped yttrium aluminium garnet) commercial cosmetic laser, and the analysis module is placed on the laser. When Nd:YAG laser is irradiated onto the skin lesion, the laser ablates a trace amount of tissue, producing micro plasma. The emitted light from the micro plasma is analysed spectrally to determine the elemental and molecular information from the tissue in real time. No calibration of the Spectra-Scope is required.
Before the skin is irradiated with the laser, select the age, sex and the position of the target skin lesion and put the patient number of the day on the software panel of laptop which is connected to the device. Prior to sampling, the skin site must be wiped with ethanol and allowed to air dry. When the laser is irradiated, the emission spectra of tissue is automatically generated from the spectrometer inside the device and simultaneously displayed on the monitor, and stored in the laptop. The spectral data stored in the laptop is wirelessly accessible using Google drive.
An algorithm then determines whether the skin is from a normal, pigmented normal, benign, squamous cell carcinoma (SCC), basal cell carcinoma (BCC) or melanoma based on the spectral 'signature'. These algorithms have been determined during clinical ex-vivo and in-vivo studies performed in Korea. The purpose of this study is to collect tissue emission spectra of Australian patients and to further refine the algorithms, and to confirm the appropriate spectra for 'normal', 'benign', 'melanoma', 'SCC', and 'BCC'.
Each potential skin cancer site, which has previously been identified as requiring biopsy, is assessed using five laser shots that last approximately 10 milliseconds per shot and measurement. The laser shots are made before the scheduled biopsy.
Some of the potential skin cancer sites will be labelled as cancers ('melanoma', 'SCC' or 'BCC') from the biopsy result, and some of the potential skin cancer site will be labelled as 'benign' (control group 1) from the biopsy result.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measurement using Spectra-Scope | Experimental | Device: Spectra-ScopeShort pulsed Nd:YAG laser irradiation onto the skin lesion / measurement with Spectra-Scope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be aged 18 years or over;
- Have at least one suspicious lesion that:
- Provide written informed consent.
Key exclusion criteria (14 listed)
- Have a known allergy to ethanol;
- Have a lesion that:
- Have an active infection;
- Have an open lesion sampled;
- Have an autoimmune disease such as lupus or scleroderma vitiligo.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectra-ScopeThe Spectra-Scope consists of the light collection module and the spectral analysis module. The light collection module is attached to the handpiece of short pulse Nd:YAG laser, and the analysis module is placed on the laser. Each potential skin cancer site, which has previously been identified as requiring biopsy, should be assessed using five laser shots that last approximately 10 milliseconds per shot and measurement. The laser shots must be made before the scheduled biopsy. All potentially cancerous lesions (or lesions that would usually undergo complete biopsy of the lesion or require follow up within three months) should be sampled. The Spectra-Scope will not provide a diagnosis at the time of sampling. Sites should record the spectra reported for each laser shot in the CRF. | Device | Measurement using Spectra-Scope |
Primary outcome
The primary endpoint is to compare the aggregated emission spectra of skin cell carcinoma verses normal skin.
Time frame: We plan to recruit 150 patients within a 3 month time frame.
The aggregated emission spectra collected over a range of wavelengths from skin cells (skin cancer verses normal skin) irradiated with a commercial laser will be plotted to identify wavelengths with greatest spectra seperation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- International Conference of Harmonisation, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human UseLink provided by the sponsor.
- World Medical Association, WMA Declaration of Helsinki - Ethical principles for medical research involving human subjects. 2008.Link provided by the sponsor.
- Dickson, P.V. and J.E. Gershenwald, Staging and prognosis of cutaneous melanoma. Surg Oncol Clin N Am, 2011. 20(1): p. 1-17.Link provided by the sponsor.
- Rosado, B., Accuracy of Computer Diagnosis of Melanoma. Archives of Dermatology, 2003. 139(3): p. 361.Link provided by the sponsor.
- Abbasi, N.R., et al., Early diagnosis of cutaneous melanoma: revisiting the ABCD criteria. JAMA, 2004. 292(22): p. 2771-6.Link provided by the sponsor.
- ISO, Clinical investigation of medical devices for human subjects - good clinical practice. ISO 14155:2011 (E). 2011.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saleem Loghdey, M.D. principal investigator
Integrated Specialist Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectra-Scope in people with Skin Cancer, run by Sung Hyun Pyun at 1 site in Australia.
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 6 inclusion and 14 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 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Sung Hyun Pyun, Ph.D. (82-10-2227-4723, ceo@speclipse.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is to compare the aggregated emission spectra of skin cell carcinoma verses normal skin. (time frame: We plan to recruit 150 patients within a 3 month time frame.). 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 20 Apr 2018.