Pigmented Skin LesionPhase 1NCT02613325
fPAM for the in Vivo Depth Measurement of Pigmented Lesions and Melanoma Depth
A Phase 1 study testing Functional photoacoustic microscopy and Single cell photoacoustic microscopy in people with Pigmented Skin Lesion and Melanoma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The investigators propose the use of functional photoacoustic microscopy (fPAM) to evaluate both benign and malignant pigmented lesions for tumor depth. Through fPAM analysis followed by histological examination, the investigators anticipate that they will be able to non-invasively determine tumor depth of pigmented… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pigmented Skin Lesion, Melanoma
- What is being tested?
- Functional photoacoustic microscopy and Single cell photoacoustic microscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2015to 27 Jun 2017
- Phase
- Phase 1
- 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
- Outcome Measure #1 and #2
- Healthy individuals with pigmented lesions or a partially biopsied melanoma whose treatment plan includes excision
- Participants must be 18 years or older
- Participants must be able to understand and willing to sign a written informed consent document
- Outcome Measures #3 and #4
- Patients with either cutaneous, visceral or brain melanoma metastases.
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- Participants must be 18 years or older.
- Participants must be Eastern Cooperative Oncology Group (ECOG) status 0-3.
- Participants must be able to understand and willing to sign a written informed consent document.
Who cannot join
- Minors, pregnant patients, incarcerated individuals, and individuals unable to give informed consent will be excluded from this study
- ECOG status > 3
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Pilot Study to Determine the Feasibility and Functionality of fPAM Imaging for the in Vivo Depth Measurement of Pigmented Lesions and Melanoma Depth
The investigators propose the use of functional photoacoustic microscopy (fPAM) to evaluate both benign and malignant pigmented lesions for tumor depth. Through fPAM analysis followed by histological examination, the investigators anticipate that they will be able to non-invasively determine tumor depth of pigmented lesions (moles and melanoma). In melanoma, tumor depth (Breslow's depth) is not only an important prognostic indicator, but also directs surgical treatment. The ultimate goal is to develop a sensitive clinical tool that will allow non-surgical evaluation of pigmented lesions, which eventually, will aid in melanoma diagnosis and management - potentially an earlier and more definitive surgical management.
In addition, the investigators propose to use the combination of fPAM and single-cell PAM to respectively image CTCs in trunk vessels and cuticle capillaries. Based on the investigators' murine models, the investigators anticipate that they will be able to differentiate CTCs from other blood cells and reliably calculate CTC concentration in a non-invasive manner. CTC concentration has been demonstrated to be a valuable indicator of a melanoma's metastatic potential and a potential tool in evaluating treatment efficacy. The ultimate goal is to develop a sensitive imaging device that will allow accurate evaluation of the risk of melanoma recurrence and metastases, that may facilitate treatment monitoring.
- Conditions
- Pigmented Skin Lesion, Melanoma
- Being tested
- Functional photoacoustic microscopy, Standard of care surgical excision, Single cell photoacoustic microscopy
- Keywords
- Melanoma, Imaging, Pigmented Lesions, Melanoma Management
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional photoacoustic microscopyDevice
Also called fPAM
-Hybrid imaging technique that detects absorbed diffusive protons ultrasonically through the photoacoustic effect.
Standard of care surgical excisionProcedure or surgery
Single cell photoacoustic microscopyDevice
Also called Single cell PAM
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: fPAM imaging & Single cell PAM imaging | Experimental | * fPAM imaging will be performed prior to scheduled excision. The time to excision will not be extended longer than 2 weeks for imaging purposes.
* When the participant presents for imaging, the area of the thickest lesion depth will be determined by fPAM. The area of deepest thickness will be marked perpendicular to the longest axis of the lesions and a clinical photo will be taken and placed in the image storage database.
* Surgical excision will be performed as standard of care and fPAM depth will be compared with histological examination.
* To image CTCs in cutaneous blood vessels, a small cuticle area on a finger will be imaged (Single cell PAM imaging) and the most distal cutaneous metastasis or metastasis of largest diameter will be imaged Receives: Device: Functional photoacoustic microscopy; Procedure: Standard of care surgical excision; Device: Single cell photoacoustic microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
In vivo studies using fPAM pigmented lesions imaging to measure tumor depth
Measured: Up to 2 weeks
Validate the lesion depth estimated by fPAM
-The thickness as measured by fPAM will be compared with the thickness of the formalin fixed excised lesion.
Measured: Up to 2 weeks
Secondary outcomes (2)
Feasibility and functionality of fPAM as measured by CTC detection
Measured: Up to 2 weeks
Feasibility and functionality of single-cell PAM as measured by CTC detection
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study start8 Jun 2015
- Primary completion27 Jun 2017
- Study completion27 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pigmented Skin LesionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lynn Cornelius, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613325
- Sponsor's protocol ID
- 201410125
- Status last verified
- Feb 2018
- First submitted
- 12 Nov 2015
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Determine the Feasibility and Functionality of fPAM Imaging for the in Vivo Depth Measurement of Pigmented Lesions and Melanoma Depth
- ClinicalTrials.gov ID
- NCT02613325
- Acronym / sponsor ID
- 201410125
- Conditions
- Pigmented Skin Lesion, Melanoma
- Keywords
- Melanoma, Imaging, Pigmented Lesions, Melanoma Management
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 8 Jun 2015 (actual)
- Primary completion
- 27 Jun 2017 (actual)
- Study completion
- 27 Jun 2017 (actual)
- First posted
- 24 Nov 2015 (estimated)
- 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 investigators propose the use of functional photoacoustic microscopy (fPAM) to evaluate both benign and malignant pigmented lesions for tumor depth. Through fPAM analysis followed by histological examination, the investigators anticipate that they will be able to non-invasively determine tumor depth of pigmented lesions (moles and melanoma). In melanoma, tumor depth (Breslow's depth) is not only an important prognostic indicator, but also directs surgical treatment. The ultimate goal is to develop a sensitive clinical tool that will allow non-surgical evaluation of pigmented lesions, which eventually, will aid in melanoma diagnosis and management - potentially an earlier and more definitive surgical management.
In addition, the investigators propose to use the combination of fPAM and single-cell PAM to respectively image CTCs in trunk vessels and cuticle capillaries. Based on the investigators' murine models, the investigators anticipate that they will be able to differentiate CTCs from other blood cells and reliably calculate CTC concentration in a non-invasive manner. CTC concentration has been demonstrated to be a valuable indicator of a melanoma's metastatic potential and a potential tool in evaluating treatment efficacy. The ultimate goal is to develop a sensitive imaging device that will allow accurate evaluation of the risk of melanoma recurrence and metastases, that may facilitate treatment monitoring.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: fPAM imaging & Single cell PAM imaging | Experimental | Device: Functional photoacoustic microscopy, Procedure: Standard of care surgical excision, Device: Single cell photoacoustic microscopy* fPAM imaging will be performed prior to scheduled excision. The time to excision will not be extended longer than 2 weeks for imaging purposes. * When the participant presents for imaging, the area of the thickest lesion depth will be determined by fPAM. The area of deepest thickness will be marked perpendicular to the longest axis of the lesions and a clinical photo will be taken and placed in the image storage database. * Surgical excision will be performed as standard of care and fPAM depth will be compared with histological examination. * To image CTCs in cutaneous blood vessels, a small cuticle area on a finger will be imaged (Single cell PAM imaging) and the most distal cutaneous metastasis or metastasis of largest diameter will be imaged |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Outcome Measure #1 and #2
- Healthy individuals with pigmented lesions or a partially biopsied melanoma whose treatment plan includes excision
- Participants must be 18 years or older
- Participants must be able to understand and willing to sign a written informed consent document
- Outcome Measures #3 and #4
Key exclusion criteria (2 listed)
- Minors, pregnant patients, incarcerated individuals, and individuals unable to give informed consent will be excluded from this study
- ECOG status > 3
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 |
|---|---|---|
| Functional photoacoustic microscopyAlso: fPAM-Hybrid imaging technique that detects absorbed diffusive protons ultrasonically through the photoacoustic effect. | Device | Arm 1: fPAM imaging & Single cell PAM imaging |
| Standard of care surgical excision | Procedure or surgery | Arm 1: fPAM imaging & Single cell PAM imaging |
| Single cell photoacoustic microscopyAlso: Single cell PAM | Device | Arm 1: fPAM imaging & Single cell PAM imaging |
Primary outcome
In vivo studies using fPAM pigmented lesions imaging to measure tumor depth
Time frame: Up to 2 weeks
Validate the lesion depth estimated by fPAM
Time frame: Up to 2 weeks
-The thickness as measured by fPAM will be compared with the thickness of the formalin fixed excised lesion.
2 secondary outcomes
Feasibility and functionality of fPAM as measured by CTC detection
Time frame: Up to 2 weeks
Feasibility and functionality of single-cell PAM as measured by CTC detection
Time frame: Up to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink 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.
Lynn Cornelius, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Functional photoacoustic microscopy and Single cell photoacoustic microscopy in people with Pigmented Skin Lesion and Melanoma, run by Washington University School of Medicine at 1 site in United States.
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 9 inclusion and 2 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: finished, as of the sponsor's last update on 14 Feb 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In vivo studies using fPAM pigmented lesions imaging to measure tumor depth (time frame: Up to 2 weeks). The study lists 2 primary outcomes in all. 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 14 Feb 2018.