Recruiting

Ocular Tumours

Sponsor:

Unity Health Toronto

Code:

NCT02909517

Conditions

Ocular Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

cSLO imaging

Study Details

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

Conditions

Ocular Melanoma

Study ID

NCT02909517

Start date

Mar, 2016

Status verified date

May, 2019

Completion date

May, 2020

Anticipated

Primary completion date

May, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Choroidal nevus

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

Choroidal indeterminate melanocytic lesion

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

Choroidal melanoma

Requires confirmation of diagnosis and evaluation for potential metatstases

Suspected metastatic tumour

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

Locally treated ocular tumour

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

Interventions

cSLO imaging

Primary outcome measure

  • Identification of macrophages [ Time Frame: 1 week ]

Central Contacts and Locations

Central contacts

Emily Mathieu, PhD

4168646060mathieue@smh.ca

Locations

St Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Princess Margaret Cancer Centre, Ontario

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Michelle Jagdat, BSc

416-864-6060jagdatm@smh.ca

Principal Investigator:

Fil Altomare, MD, FRCSC

More Information

Sponsor

Unity Health Toronto

Last update posted

May 23, 2019

Last verified

May, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2019-05-23.