NCT02009085

Brief Summary

In this study a fluorescent contrast dye is applied to a suspicious skin lesion. Images are acquired and processed. The information is used to develop a prediction model for the presence of malignant transformation in the skin.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

4 years

First QC Date

November 25, 2013

Last Update Submit

February 14, 2018

Conditions

Skin Lesions

Outcome Measures

Primary Outcomes (1)

  • Correlation between imaging and pathology.

    Patients are imaged and then undergo a biopsy. Images are used to develop a software predicting model based on pathology. Sensitivity and specificity parameters are calculated. No long term follow up is required since the biopsy is performed on the skin imaged. The follow up required is for the pathology for the skin excised.

    No long term follow up is necessary.

Secondary Outcomes (1)

  • Acute response

    up to 1 day

Other Outcomes (1)

  • None specified.

    0

Study Arms (1)

Individuals undergoing skin excision.

Skin lesions are under suspicion for skin cancer.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients above 18 years scheduled for a skin biopsy.

You may qualify if:

  • Over the age of 18
  • Individual is scheduled for a skin biopsy in toto
  • The lesion is pigmented or non pigmented
  • Lesions may be under suspicion for basal cell carcinoma, squamous cell carcinoma, actinic keratosis, nevi, melanoma, seborrheic keratosis.
  • The lesion is accessible to the imaging device

You may not qualify if:

  • The patient has sensitive skin and easily breaks out in rash
  • The lesion is within 1 cm of the eye
  • The lesion is on mucosal surfaces (e.g., lips, genitals)
  • Pregnant females
  • Taking medications that pigments the skin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Yehuda Ullmann, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2013

First Posted

December 11, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

February 19, 2018

Record last verified: 2018-02