The Role of Inflammation in Ocular Tumours

Ocular Melanoma Clinical Trial

Official title:

The Role of Inflammation in Ocular Tumours

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02909517
• Other study ID #: 14-416
• Status: Recruiting
• Start date: March 2016
• Est. completion date: May 2020

Study information

• Verified date: May 2019
• Source: St. Michael's Hospital, Toronto
• Contact: Emily Mathieu, PhD
• Phone: 4168646060
• Email: mathieue[@]smh.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Neoplasms
• Inflammation
• Ocular Melanoma

Intervention

Other:
• cSLO imaging

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre, Ontario	Toronto	Ontario
Canada	St Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of macrophages		1 week