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Ultrasound Microvessel Imaging for Differentiation of Ocular Tumors

Overview

About this study

The purpose of ths study is to evaluate a contrast-free ultrasound tool for the visualization and quantification of tumor microvessel morphologies, called quantitative high-definition microvessel imaging (qHDMI). This technology includes three components: (1) novel processing procedures to reveal small microvasculatures using high frame rate ultrasound imaging; (2) quantification procedures to analyze the morphology of the microvasculatures in terms of 10 parameters (e.g., tortuosity, branch angle, number of branch points, etc.); and (3) a classification method to automatically determine if the lesion is benign or malignant based on its morphological signature. 

The proposed technique is noninvasive, affordable, portable, and utilizes tools without the risks and adverse effects inherent to the use of contrast agents. This project includes several novelties, including the innovative approach to differentiate benign versus malignant ocular tumors without using contrast agents, quantitative assessment of microvessel morphology for automated classification of the ocular tumor, and the first application of the proposed approach in a clinical study on patients with ocular/orbital tumors.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male and female, age 18 and older.
  • Suspected of having eye tumor.

AIM 1 - SUBSET OF LARGE CHOROIDAL NEVI:

Inclusion Criteria:

  • Lesions with thickness > 1.5 mm and minimum documented stability interval of 2 years.

Exclusion Criteria:

  • Lesions with thickness < 1.5 mm or fewer than 2 years of documented stability.

SUBSET LARGE MELANOMA:

Inclusion Criteria:

  • Choroidal, ciliary body, or ciliochoroidal melanoma in a patient who elected to have enucleation for primary tumor treatment.

Exclusion Criteria:

  • Iris melanoma or melanoma that has undergone prior treatment before enucleation.

PRESUMED CHOROIDAL MELANOMA:

Inclusion Criteria:

  •  Choroidal, ciliary body, or ciliochoroidal melanoma with thickness > 1.5 mm treated by radiation. These lesions may sometimes have biopsy for cytogenetic testing at the time of radiation treatment.

Exclusion Criteria:

  • Iris melanoma, lesions with thickness < 1.5 mm, non-melanoma tumors.

AIM 2

Inclusion Criteria:

  • Orbital mass with completed neuroimaging (typically with MRI) and clinical/MRI suspicion for lymphoma.

Exclusion Criteria:

  • Recent orbital biopsy (within the past 3 months) prior to qHDMI, clinical impression clearly compatible with a non-lymphoma tumor type.

Eligibility last updated 2/18/22. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Azra Alizad, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Azra Alizad M.D.

(507) 538-1727

Alizad.Azra@mayo.edu

More information

Publications

Publications are currently not available

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CLS-20540954

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