In Vivo Confocal Microscopy Study of Pigmented Conjunctival Lesions

NCT01993654 | Terminated

• 1 other identifier: 09-04-028
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

This study aims to validate the use of laser in vivo confocal microscopy as an early diagnostic and differentiation tool of pigmented conjunctival lesions, evaluate the efficacy of in vivo confocal microscopy for follow-up (as a visualizing tool) after tumor resection for early detection of tumor recurrence, and to evaluate the use of in vivo confocal microscopy in evaluation of response to treatment. The modified technique with Heidelberg Retina Tomography (HRT) confocal microscopy and anterior segment optical coherence tomography (OCT) are non-invasive, no-touch, imaging techniques that may help in differentiation of benign lesions like nevi or racial melanosis, from malignant lesions like primary acquired melanosis and malignant melanomas. The OCT will potentially allow to estimate tumor depth in vivo as preliminary studies have shown.

Conditions

Nevus; Racial Melanosis; Primary Acquired Melanosis; Conjunctival Malignant Melanoma

Keywords

Pigmented Lesions; PAM; Ocular lesion

Outcome Measures

Primary Outcomes (1)

• Pigmented conjunctival lesions

  Heidelberg Retina Tomography (HRT) and Optical Coherence Tomography (OCT) will be used to measure pigmented conjunctival lesions. (HRT) is performed with a confocal scanning laser ophthalmoscope. Along with corneal analysis software, the HRT is able to image cells and cell layers within the cornea. Optical Coherence Tomography (OCT) is a noninvasive optical imaging modality analogous to an ultrasound B-scan. OCT images will be used to estimate tumor depth. Immunohistochemistry results will be recorded from stained tissue samples obtained during surgical resections scheduled for study subjects with newly diagnosed conjunctival lesions. These patients will have HRT and OCT imaging performed prior to their standard of care surgery to remove the conjunctival lesion. Histologic and immunohistochemistry results and clinicopathologic findings will be analyzed by two observers and correlated with IVCM and OCT images of the same lesions.

  Day 1

Study Arms (5)

Nevus

Procedure: HRT III with Non-Contact Cornea Rostock Module

Racial Melanosis

Procedure: HRT III with Non-Contact Cornea Rostock Module

Primary Acquired Melanosis

Procedure: HRT III with Non-Contact Cornea Rostock Module

Malignant Melanoma

Procedure: HRT III with Non-Contact Cornea Rostock Module

Normal

Procedure: HRT III with Non-Contact Cornea Rostock Module

Interventions

HRT III with Non-Contact Cornea Rostock Module PROCEDURE

Confocal imaging of the conjunctival lesion

Malignant Melanoma; Nevus; Normal; Primary Acquired Melanosis; Racial Melanosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male or female patients over the age of 18 and belonging to one of the following groups will be recruited for this study. Group 1: Nevus Group 2: Racial melanosis Group 3: Primary Acquired Melanosis Group 4: Malignant Melanoma of the Conjunctiva Group 5: Normal Subjects with no pigmented lesions Normal subjects will be recruited from patients normally seen during clinic for cataract evaluations. Groups 1-4 will be identified by the investigators at MEEI and other 2 sites as potential study subjects during regular clinic visits.

You may qualify if:

• Age over 18 years
• The ability to provide informed consent for enrollment in the study
• Diagnosis of conjunctival nevus (Group 1 only)
• Diagnosis of racial melanosis (Group 2 only)
• Diagnosis or suspicion of primary acquired melanosis (PAM), scheduled for biopsy (Group 3 only)
• Diagnosis of possible MM scheduled for biopsy (Group 4 only)
• Confirmed diagnosis of MM based upon clinical and histopathological findings, and have already undergone resection(Group 4 only)
• Confirmed diagnosis of MM recurrence based upon clinical and histopathological findings(Group 4 only)
• Clear cornea (Group 5 only)
• No conjunctival lesions or recent conjunctival diseases(Group 5 only)
• No recent chemotherapy or radiotherapy(Group 5 only)

You may not qualify if:

• History of previous ocular surgery within last 3 months
• History of inflammatory eye diseases within last 3 months
• Current or history of glaucoma disease and on glaucoma medication
• Contact lens use within last 3 months
• Physical inability to cooperate for confocal microscopy
• Prior history of infectious keratitis within 3 months
• Suspicion for PAM or malignant melanoma (MM)(Groups 1,2,3)
• History of PAM or MM(Groups 1,2,3)
• Histopathology not confirmatory for MM (group 4 only)
• History of other ocular carcinoma or any recent ocular topical chemotherapy or radiotherapy (Group 5 only)
• History of cancer elsewhere in the body which is currently under systemic chemotherapy (group 5 only)

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead
• M.D. Anderson Cancer Center: collaborator
• Wills Eye: collaborator

Study Sites (3)

Massachusetts Eye & Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Nevus

Condition Hierarchy (Ancestors)

Nevi and Melanomas; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Pedram Hamrah, MD

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

• Carol Shields, MD

  Wills Eye Hospital

  PRINCIPAL INVESTIGATOR

• Arman Mashayekhi, MD

  Wills Eye Hospital

  PRINCIPAL INVESTIGATOR

• Bita Esmaeli, MA, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: November 25, 2013
• Study Start: September 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 15, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)