NCT02909517

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

May 23, 2019

Status Verified

May 1, 2019

Enrollment Period

4.2 years

First QC Date

September 16, 2016

Last Update Submit

May 21, 2019

Conditions

Ocular Melanoma

Outcome Measures

Primary Outcomes (1)

  • Identification of macrophages

    1 week

Study Arms (5)

Choroidal nevus

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

Other: cSLO imaging

Choroidal indeterminate melanocytic lesion

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

Other: cSLO imaging

Choroidal melanoma

Requires confirmation of diagnosis and evaluation for potential metatstases

Other: cSLO imaging

Suspected metastatic tumour

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

Other: cSLO imaging

Locally treated ocular tumour

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

Other: cSLO imaging

Interventions

cSLO imagingOTHER
Choroidal indeterminate melanocytic lesionChoroidal melanomaChoroidal nevusLocally treated ocular tumourSuspected metastatic tumour

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Potential study subjects will be identified from within the circle of care of the attending physicians. Subjects must be 18 years of age or older, be able to understand the study protocol, and provide informed consent. They must be able to attend all three visits

You may qualify if:

  • Any tentative clinical diagnosis of:
  • Choroidal nevus (low-risk features):
  • Choroidal indeterminate melanocytic lesion (high-risk features)
  • Choroidal melanoma
  • Suspected metastatic tumour (ie, primary tumour elsewhere)
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Princess Margaret Cancer Centre, Ontario

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Uveal Melanoma

Condition Hierarchy (Ancestors)

MelanomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsEye NeoplasmsNeoplasms by SiteEye DiseasesUveal Diseases

Study Officials

  • Shelley Boyd, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Mathieu, PhD

CONTACT

4168646060mathieue@smh.ca

Study Design

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

Study Record Dates

First Submitted

September 16, 2016

First Posted

September 21, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

May 23, 2019

Record last verified: 2019-05

Locations

CA(2)