The Role of Inflammation in Ocular Tumours

Unity Health Toronto

Status: Unknown

Conditions: Ocular Melanoma

Treatments: Other: cSLO imaging

Study type: Observational

Funder types: Other

Identifiers

NCT02909517

14-416

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 5 patient groups

Choroidal nevus

Description:

Requires distinction from melanoma through diagnostic testing (low-risk features)

Treatment:

Other: cSLO imaging

Choroidal indeterminate melanocytic lesion

Description:

Requires diagnostic testing for identification and distinction from nevus and melanoma (high-risk features)

Treatment:

Other: cSLO imaging

Choroidal melanoma

Description:

Requires confirmation of diagnosis and evaluation for potential metatstases

Treatment:

Other: cSLO imaging

Suspected metastatic tumour

Description:

Requires identification of primary tumour (ie, primary tumour elsewhere)

Treatment:

Other: cSLO imaging

Locally treated ocular tumour

Description:

Requires followup to evaluate response to treatment and potential change or repeat therapy

Treatment:

Other: cSLO imaging