Plain English Summary
Background and study aims
Mycosis fungoides is the most common form of a type of blood cancer called cutaneous T-cell lymphoma. Cutaneous T-cell lymphomas occur when certain white blood cells, called T cells, become cancerous; these cancers characteristically affect the skin, causing different types of skin lesions.
The diagnosis of Mycosis fungoides is often delayed since the skin lesions look similar to other skin diseases. While in many cases a diagnosis of skin diseases can be made clinically and does not require a skin biopsy, the diagnosis of Mycosis fungoides requires a skin biopsy and sometimes many skin biopsies are needed to make the correct diagnosis.
A possible new method for diagnosis is skin ultrasound, which is a fast method (done within minutes) and causes no harm or pain.
Who can participate?
Patients who have been diagnosed with Mycosis fungoides.
What does the study involve?
The study involves the application of ultrasound and dermoscopy (as non-invasive techniques) for the assessment of cutaneous lymphoma lesions.
What are the possible benefits and risks of participating?
There are no direct benefits for the patients and no potential risks of participation are anticipated.
Where is the study run from?
Sunnybrook Health Sciences Centre, Toronto, Canada
When is the study starting and how long is it expected to run for?
December 2019 to June 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Iris Wohlmuth-Wieser
Dr Raed Alhusayen
The implementation of novel imaging techniques for the evaluation of cutaneous lymphomas
The aim of the study is to prospectively obtain high-frequency ultrasound images (HF-USG) in MF patients of different stages of the disease, in order to describe baseline HF-USG criteria for MF and to compare the HF-USG images with dermoscopy and macroscopic images from the same index skin lesion
Approved 29/10/2019, Research Ethics Board, Sunnybrook Health Sciences Centre (2075 Bayview Ave, Toronto, M4N 3M5, Ontario, Canada; +1 416-480-6100; firstname.lastname@example.org), ref: 299-2019
Prospective single-center observational cohort study
Primary study design
Secondary study design
Patient information sheet
No participant information sheet available
Mycosis fungoides (cutaneous lymphoma)
The study is designed to investigate the applicability of HF-USG in patients with mycosis fungoides using Vevo MD®; FUJIFILM VisualSonics, Toronto, ON, Canada ultrasound machine and to describe baseline ultrasound charateristics for mycosis fungoides and to compare these findings with standard dermoscopy.
Non-invasive standard dermoscopy and ultrasound images will be obtained from an index lesion of the patient. The patient will remain under standard of care. There will be no additional biopsies obtained for study purposes. The investigators will only take non-invasive images as described above, thus not imposing any potential harm to the patient. The total duration of the observation is expected to take 30 minutes (one single visit). No follow-up visits are planned for this study.
Vevo MD® ultrasound machine
Primary outcome measure
Ultrasound characteristics (morphology of the epidermis, dermis and subcutis) for mycosis fungoides measured using the Vevo MD® ultrasound machine at the time of investigation
Secondary outcome measures
Dermoscopy characteristics (pattern of the skin lesion including the morphology of vessels, follicular openings and the color of scales) for mycosis fungoides measured using skin surface microspcopy at the time of investigation
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
Patch or plaque stage mycosis fungoides
Target number of participants
Total final enrolment
Participant exclusion criteria
1. Clinical suspicion of mycosis fungoides lacking definitive histopathologic proof
2. Mycosis fungoides with generalized erythroderma
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Sunnybrook Health Sciences Centre
2075 Bayview Avenue
Investigator initiated and funded
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
We plan to publish our data in a pubmed-listed journal.
The study protocol is available on request from the study contacts.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)