Dynamic Contrast-Enhanced MRI for Eye Cancer

Overseen By Michael Knopp, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Disqualifiers: Pacemaker, Pregnancy, Renal insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Dynamic Contrast-Enhanced MRI for eye cancer?

Dynamic Contrast-Enhanced MRI (DCE-MRI) has been shown to effectively assess the blood supply characteristics of ocular melanoma, which can help predict the potential for the cancer to spread. In a study, 98% of ocular melanomas showed strong signal enhancement, and this was linked to a higher risk of the cancer spreading, suggesting DCE-MRI can be a useful tool in managing eye cancer. ^{1 2 3 4 5}

Is Dynamic Contrast-Enhanced MRI safe for humans?

Dynamic Contrast-Enhanced MRI has been used in studies for eye conditions like ocular melanoma and choroidal melanoma, and it involves the use of contrast agents like gadolinium to improve imaging. While these studies focus on imaging effectiveness, they do not report specific safety concerns related to the use of this imaging technique. ^{2 4 6 7 8}

How does the treatment Dynamic Contrast-Enhanced MRI differ from other treatments for eye cancer?

Dynamic Contrast-Enhanced MRI is unique because it provides detailed images of the blood vessels in eye tumors, helping to predict the tumor's potential to spread. This imaging technique is not typically used for eye cancers due to challenges like small lesion size and eye movement, but it offers valuable insights into tumor characteristics and treatment response. ^{2 3 4 7 9}

What is the purpose of this trial?

This study is being done due to a new imaging method that may help others in the future to improve evaluation of diseases in the eye and eye socket and to help make a decision concerning best treatment of the disease. Previous studies suggests that dynamic contrast enhanced MRI is ideally suited to show small structures in the eye and eye socket as well as to provide information about the eye socket such as blood circulation. This research may also provide information about the likelihood of the tumor spreading from the eye into other organs as well as correlate the study images with all other clinical imaging

Research Team

Michael Knopp

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for individuals who need further diagnosis or monitoring of an orbital mass (eye or eye socket tumor) and can return for follow-up visits. They must be able to give informed consent. It's not suitable for those with severe kidney issues, certain metal implants, allergies to metals or contrast agents, claustrophobia, pregnant women, prisoners, or anyone under conditions that would interfere with MRI.

Inclusion Criteria

Able to give informed consent

Return for follow-up visits

I have a growth in my eye area that needs more tests before treatment.

Exclusion Criteria

My kidneys work well and I don't have severe renal insufficiency.

The patient should not participate in this study if any of the following applies to the patient: the patient has a pacemaker, metallic cardiac valve(s), magnetic material such as surgical clips, implanted electronic infusion pumps or any other condition that would interfere with the MRI, the patient has a stent somewhere in the body, the patient has a history of allergic reaction to any metals, contrast agents, x-ray dyes, the patient has claustrophobia

Patients with a lesion < 2 mm

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Patients undergo dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) to evaluate ocular and orbital tumors

Follow-up

Participants are monitored for safety and effectiveness after imaging

Up to 5 years

Follow-up every 6 months

Treatment Details

Interventions

• Dynamic Contrast-Enhanced MRI

Trial Overview The study tests a new imaging method using dynamic contrast-enhanced MRI to improve the evaluation of diseases in the eye and orbit. It aims to provide detailed images and information about blood circulation in these areas which may help determine if the tumor could spread.

Participant Groups

Group I: Dynamic contrast-enhanced MRI Experimental Treatment 1 Intervention

Patients undergo Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI)

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Uveal Melanoma Metastatic to the Liver: The Role of Quantitative Volumetric Contrast-Enhanced MR Imaging in the Assessment of Early Tumor Response after Transarterial Chemoembolization. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Dynamic contrast-enhanced MRI of ocular melanoma. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Dynamic Contrast-Enhanced Magnetic Resonance Imaging of Ocular Melanoma as a Tool to Predict Metastatic Potential. [2017]

4. Germany pubmed.ncbi.nlm.nih.gov

Eye-specific quantitative dynamic contrast-enhanced MRI analysis for patients with intraocular masses. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The role of magnetic resonance imaging in children with intraocular tumors and simulating lesions. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Dynamic contrast-enhanced magnetic resonance imaging for monitoring the anti-angiogenesis efficacy in a C6 glioma rat model. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

MRI of Uveal Melanoma. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of choroidal melanoma with and without gadolinium contrast enhancement. [2019]

9. China pubmed.ncbi.nlm.nih.gov

[MR subtraction in the differentiation of benign and malignant tumors]. [2018]