The Role of Inflammation in Ocular Tumours

• Conditions: Ocular Melanoma
• Interventions: Other: cSLO imaging

• Registration Number: NCT02909517
• Lead Sponsor: Unity Health Toronto

Brief Summary

This prospective, non-therapeutic study will determine whether a novel imaging technique can identify presumptive tumour associated macrophages (TAMs) in patients with ocular tumours.

The investigators will evaluate 5 groups:

1. Choroidal nevus

2. Choroidal indeterminate melanocytic lesion

3. Choroidal melanoma

4. Suspected metastatic tumour (ie, primary tumour elsewhere)

5. Locally treated ocular tumours

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-09-16
• Study First Submitted QC: 2016-09-16
• Study First Posted: 2016-09-21
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-23
• Primary Completion: 2020-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Any tentative clinical diagnosis of:

1. Choroidal nevus (low-risk features):
2. Choroidal indeterminate melanocytic lesion (high-risk features)
3. Choroidal melanoma
4. Suspected metastatic tumour (ie, primary tumour elsewhere)
5. Locally treated ocular tumours

Note that a patient can enroll in this study twice, once before treatment and once after, provided that at least one month has passed since initiation of treatment. This patient will count twice (ie, once in each of two study arms)

Male and female age 18 years and older Ability to provide informed consent

Exclusion Criteria

• Allergy to angiography dye
• Cases that do not meet the above criteria for tumor size will be ineligible to participate in the study.
• Patients not able to provide consent for the study.
• Patients with a poor view of the fundus due to cataract or vitreous hemorrhage.
• Patients < 18 years of age. Any concurrent unrelated eye diagnosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suspected metastatic tumour	cSLO imaging	Requires identification of primary tumour (ie, primary tumour elsewhere)
Choroidal nevus	cSLO imaging	Requires distinction from melanoma through diagnostic testing (low-risk features)
Choroidal indeterminate melanocytic lesion	cSLO imaging	Requires diagnostic testing for identification and distinction from nevus and melanoma (high-risk features)
Choroidal melanoma	cSLO imaging	Requires confirmation of diagnosis and evaluation for potential metatstases
Locally treated ocular tumour	cSLO imaging	Requires followup to evaluate response to treatment and potential change or repeat therapy

Primary Outcome Measures

Name	Time	Method
Identification of macrophages	1 week

Trial Locations

Locations (2)

Princess Margaret Cancer Centre, Ontario; 🇨🇦 Toronto, Ontario, Canada

St Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada