Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Melanoma

Skin Neoplasms

Lentigo

Hutchinson's Melanotic Freckle

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Melanosis

Hyperpigmentation

Pigmentation Disorders

Neuroendocrine Tumor

Neuroepithelioma

Skin cancer is imaged using RCM and a diagnosis is recorded before patient is returned to standard of care (biopsy).

In-vivo imaging

Howard Stevens, MA PhD

A reflectance confocal microscope is a machine which is able to examine the upper layers of the skin painlessly and without the need for taking a biopsy. We would like to examine the images taken by the confocal microscope to see if it can help more accurately identify lesions which are worrying rather than a benign mole. We are performing this study in patients in whom we have recommended excising a mole to exclude a cancer. If the results of the study show that the confocal microscope can help more accurately diagnose Melanomas then this would reduce the number of biopsies that are taken that turn out not to be cancerous (ie unnecessary biopsies).

Study Design This is an observational, non-randomised, non-controlled, prospective cohort study to look at the efficacy of in vivo RCM as a diagnostic tool in the diagnosis of MM and LM.

Study Endpoints The hypothesis of this study is that the use of RCM is would reduce the NNE prior to definitive treatment by at least 30% from the current value of approximately 10.

The secondary hypothesis is that the intra- \& inter-observer agreement for interpreting the RCM images will have kappa scores 0.6 or greater (indicating good agreement).

Setting and recruitment Patients will be recruited from the outpatient clinics of the Skin Care Network Barnet, and from the outpatient clinics of the Chase Farm and Barnet sites of Royal Free Hospital NHS Foundation Trust.

Participants The number of true negative lesions examined in this study will be 654. It is anticipated that this will result in a total of 661 lesions being recruited. 10% of participants are expected to have more than one lesion sampled.

The result of biopsy for each lesion will not be known until after the lesion has been included in the study. Therefore lesions will be added to the study until the required number of true negatives has been included.

Reflectance Confocal Microscopy to Diagnose MM & LM

Reflectance Confocal Microscopy to Diagnose Malignant Melanoma and Lentigo Maligna

The number of suspicious lesions (defined by conventional histology) biopsied to find one cancerous lesion

A measure of how consistently readers can diagnose from confocal images.

Skin Care Network Ltd.

Carcinoma

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms, Basal Cell

It is proposed to undertake a study to determine the diagnostic utility of using RCM for the diagnosis of Basal Cell Carcinoma (BCC) in a tertiary referral centre as outlined by the recent NICE report (Nov 2015). This will allow an assessment of the potential to avoid diagnostic biopsy within the treatment pathway.

Study Design This is an observational, non-randomised, non-controlled, prospective cohort study to look at the efficacy of in vivo RCM as a diagnostic tool in the diagnosis of BCC.

Study Hypothesis The hypothesis of this study is that the use of RCM is would enable a reduction in the number of diagnostic biopsies taken before definitive treatment of BCC by at least 50%.

The secondary hypothesis is that the intra- \& inter-observer agreement for interpreting the RCM images will have kappa scores 0.6 or greater (indicating good agreement).

Patients will be recruited from the outpatient clinic of Skin Care Network London.

Reflectance Confocal Microscopy to Diagnose BCC

Reflectance Confocal Microscopy to Diagnose Basal Cell Carcinoma

Specificity \& Sensitivity of RCM in diagnosing Basal Cell Carcinoma in non-pigmented lesions compared to standard histology

The SECM skin imaging procedure will be very similar to that by the FDA approved RCM devices. First, the skin lesion (such as a mole) will be identified on a forearm of the subject. The lesion will be imaged first with a dermatoscope, and then with the SECM device. A dermatoscope is a hand-held device used for the visual observation of the epidermis. It is a superior surface contact microscope used to examine skin lesions.

Consented Participants will be asked to allow their forearm to be imaged by the dermatoscope on the same skin/lesions as a control comparison. We will be trying to image pigmented skin/lesions present on the forearm. This will be followed by imaging using the SECM Skin imaging device

SECM Skin Imaging

Guillermo Tearney, M.D, PhD.

The aim of this study is to evaluate the imaging performance of Spectrally Encoded Confocal Microscopy (SECM) for imaging human skin and skin diseases.

SECM provides an order of magnitude faster imaging speed than conventional confocal microscopy devices. The investigators have previously utilized the SECM technology for imaging large area of human esophagus in vivo. They have also developed endoscopic capsule devices which have been used to safely image over 60 human subjects, healthy volunteers and subjects with eosinophilic esophagitis, using SECM technology, rapidly.

When used for skin imaging, SECM can provide real-time three-dimensional confocal imaging and significantly reduce the imaging time. While SECM has been successfully used for imaging human esophagus in vivo, its utility in skin imaging needs to be tested in a new pilot study. The investigators will be taking images with a dermatoscope as well. This will the control to compare the experimental images to, as the dermatoscope is the standard of care diagnostic tool for dermatologists.

Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy

The quality, resolution and depth of the images will be reviewed by the PI. This is a qualitative analysis to determine the feasibility of the device, the parameters mentioned will be compared to correlative data obtained from the dermatoscope control. Unit measurements are not available.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Reflectance Confocal Microscopy to Diagnose MM & LM	NCT03508297	Melanoma (Skin) Lentigo Maligna	In-vivo imaging	18 Years -	Skin Care Network Ltd.
Reflectance Confocal Microscopy to Diagnose BCC	NCT03509415	Basal Cell Carc...	In-vivo imaging	18 Years -	Skin Care Network Ltd.
Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy	NCT04566302	Pigmented Lesio... Pigmented Skin ... Pigmented Moles Skin Lesion	SECM Skin Imagi...	18 Years -	Massachusetts General Hospital

Spots Global Cancer Trial Database for rcm

Every month we try and update this database with for rcm cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rcm

Every month we try and update this database with for rcm cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rcm cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.