MelanomaNCT01118832
Using High Resolution Function Imaging To Detect Melanoma and Dysplastic Nevi
An observational study of Melanoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
A novel infrared imaging tool to aid in the clinical detection of atypical pigmented lesions and melanoma is developed. Goals include evaluation of the utility of high-resolution infrared scanning of cutaneous lesions in the diagnosis of pigmented lesions and the identification of high-risk lesions and melanomas. Read more about this study
- Who is it for?
- Ages 10 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2009to 20 Feb 2012
- Phase
- Observational
- 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 10 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The subject population will be identified in the Department of Dermatology Pigmented Lesion Clinic at the Johns Hopkins Hospital Outpatient Center. Recruited patients will only comprise those requesting a cutaneous pigmented lesion removed or patients that are examined and found to have a pigmented lesion that is suspicious for malignancy at the time of their visit, and thus recommended to have a skin biopsy for diagnosis following the standard of care
Who may be able to join
- Patients seen in the high-risk pigmented lesion clinic, who posses a pigmented lesion with a clinical indication for biopsy
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
A novel infrared imaging tool to aid in the clinical detection of atypical pigmented lesions and melanoma is developed. Goals include evaluation of the utility of high-resolution infrared scanning of cutaneous lesions in the diagnosis of pigmented lesions and the identification of high-risk lesions and melanomas.
Read the detailed description
This study uses a specific skin protocol to cool the skin and then measures the cutaneous thermal recovery to uniquely identify lesions that may be cancerous. Using computer models, the thermal signature is used to determine the size and shape of the lesions in question. In particular, this study seeks to add quantification analysis of high resolution thermal images of melanoma lesions to provide accurate early diagnostic capability with specific detail regarding size, shape and depth of the lesions. This information will be compared to biopsy results and surgical resection results.
- Conditions
- Melanoma
- Keywords
- Thermography
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to Detect of the melanoma lesions
Using activated cooling methods we are measuring skin surface temperature recovery of specific lesions and comparing them to biopsy results of the lesions in question.
Measured: up to 2 years
Secondary outcomes (1)
Measurement of thermal signatures of benign cutaneous lesions
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study start22 Sep 2009
- Primary completion29 Jun 2010
- Study completion20 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Cila Herman, Dr-Ing., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118832
- Sponsor's protocol ID
- J0868
- Other IDs
- R01CA161265-02, NA_00016040
- Status last verified
- Feb 2019
- First submitted
- 5 May 2010
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
C HERMAN, THREE-DIMENSIONAL THERMAL IMAGING FOR THE DETECTION OF SKIN LESIONS AND OTHER NATURAL AND ABNORMAL CONDITIONS - WO Patent WO/2012/009,359, 2012
Herman C. Emerging technologies for the detection of melanoma: achieving better outcomes. Clin Cosmet Investig Dermatol. 2012;5:195-212. doi: 10.2147/CCID.S27902. Epub 2012 Nov 12.
PubMed 23204850
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using High Resolution Function Imaging To Detect Melanoma and Dysplastic Nevi
- ClinicalTrials.gov ID
- NCT01118832
- Acronym / sponsor ID
- J0868
- Conditions
- Melanoma
- Keywords
- Thermography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Johns Hopkins University, National Cancer Institute (NCI)
- Study start
- 22 Sep 2009 (actual)
- Primary completion
- 29 Jun 2010 (actual)
- Study completion
- 20 Feb 2012 (actual)
- First posted
- 7 May 2010 (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.
A novel infrared imaging tool to aid in the clinical detection of atypical pigmented lesions and melanoma is developed. Goals include evaluation of the utility of high-resolution infrared scanning of cutaneous lesions in the diagnosis of pigmented lesions and the identification of high-risk lesions and melanomas.
Detailed description
This study uses a specific skin protocol to cool the skin and then measures the cutaneous thermal recovery to uniquely identify lesions that may be cancerous. Using computer models, the thermal signature is used to determine the size and shape of the lesions in question. In particular, this study seeks to add quantification analysis of high resolution thermal images of melanoma lesions to provide accurate early diagnostic capability with specific detail regarding size, shape and depth of the lesions. This information will be compared to biopsy results and surgical resection results.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The subject population will be identified in the Department of Dermatology Pigmented Lesion Clinic at the Johns Hopkins Hospital Outpatient Center. Recruited patients will only comprise those requesting a cutaneous pigmented lesion removed or patients that are examined and found to have a pigmented lesion that is suspicious for malignancy at the time of their visit, and thus recommended to have a skin biopsy for diagnosis following the standard of care
Key inclusion criteria (1 listed)
- Patients seen in the high-risk pigmented lesion clinic, who posses a pigmented lesion with a clinical indication for biopsy
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ability to Detect of the melanoma lesions
Time frame: up to 2 years
Using activated cooling methods we are measuring skin surface temperature recovery of specific lesions and comparing them to biopsy results of the lesions in question.
1 secondary outcome
Measurement of thermal signatures of benign cutaneous lesions
Time frame: up to 2 years
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 8 Feb 2019.
- BackgroundC HERMAN, THREE-DIMENSIONAL THERMAL IMAGING FOR THE DETECTION OF SKIN LESIONS AND OTHER NATURAL AND ABNORMAL CONDITIONS - WO Patent WO/2012/009,359, 2012
- Results publication: PubMed 23204850Herman C. Emerging technologies for the detection of melanoma: achieving better outcomes. Clin Cosmet Investig Dermatol. 2012;5:195-212. doi: 10.2147/CCID.S27902. Epub 2012 Nov 12.
- Video article describing the melanoma scannerLink provided by the sponsor.
- Review article discussing emerging technologies for the detection of melanomaLink provided by the sponsor.
- Johns Hopkins News release about the infrared scanner for detection of skin cancerLink provided by the sponsor.
Related trials for Melanoma
RecruitingPhase 3
Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma
Advanced (Unresectable or Metastatic) Melanoma
Not yet recruiting
A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced / Metastatic Solid Tumors.
NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Cancer)
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Enrolling by invitation
TruScore Standalone Clinical Study
Melanoma and Other Malignant Neoplasms of Skin, Basal Cell Carcinoma of Skin
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
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.
Cila Herman, Dr-Ing. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 1 inclusion and 1 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 8 Feb 2019. 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.
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?
Ability to Detect of the melanoma lesions (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01118832, which also lists 2 linked publications.
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 8 Feb 2019.