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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new MRI method called Dynamic Contrast-Enhanced MRI to provide a clearer view of eye cancers and their surroundings. The goal is to enhance how doctors evaluate and decide on treatments for these conditions, including assessing the likelihood of cancer spreading. Individuals with an eye mass requiring further diagnosis before treatment or monitoring might be suitable for this trial. As an unphased study, this trial offers participants the chance to contribute to innovative diagnostic advancements in eye cancer care.

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 prior data suggests that this imaging method is safe for evaluating eye diseases?

Research has shown that Dynamic Contrast-Enhanced MRI (DCE-MRI) is commonly used in medical imaging. This method helps doctors visualize tumors and assess treatment effectiveness. So far, studies have not identified any specific safety concerns with using this imaging method for eye cancer.

DCE-MRI uses a special dye to enhance image clarity, providing doctors with more information about the tumor and its blood flow. While studies focus on the effectiveness of DCE-MRI, they do not report any particular safety issues, suggesting that DCE-MRI is generally safe.

Overall, current research provides no evidence of major safety problems with DCE-MRI. This is reassuring for anyone considering participation in a study using this technique. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Dynamic Contrast-Enhanced MRI (DCE-MRI) for eye cancer because it offers a non-invasive way to gather detailed images of the eye's internal structures. Unlike traditional imaging methods such as CT scans or standard MRIs, DCE-MRI provides dynamic, real-time insights into blood flow and tissue characteristics, which can help in precisely detecting and characterizing tumors. This enhanced imaging capability could lead to more accurate diagnoses and better treatment planning, potentially improving patient outcomes.

What evidence suggests that this imaging method is effective for evaluating eye cancer?

Research has shown that Dynamic Contrast-Enhanced MRI (DCE-MRI), which participants in this trial will undergo, is useful for examining eye tumors. It creates detailed images of the eye and its blood flow, aiding in the diagnosis of conditions like ocular melanoma. Studies have found that DCE-MRI can predict whether a tumor might spread to other parts of the body. This method distinguishes between cancerous and non-cancerous tumors by measuring how a special dye moves through the blood vessels. This imaging technique provides important information that can help doctors make better treatment decisions. ^{1 2 6 7 8}

Who Is on the Research Team?

Michael Knopp

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8995252/

Eye-specific quantitative dynamic contrast-enhanced MRI ... Using this eye-specific analysis, DCE of intraocular masses is possible which might aid in the diagnosis, prognosis and follow-up of UM.

2. withpower.com withpower.com/trial/phase-eye-neoplasms-5-2004-70022

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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01653080?cond=%22Eye%20Neoplasms%22&viewType=Table&rank=6

MRI in Diagnosing Solid Tumors of the Eye and Orbit Dynamic Contrast Enhanced Magnetic Resonance Imaging for Non-Invasive Diagnostic Work-Up in Solid Tumors of the Eye and Orbit. Conditions. Eye Cancer.

4. researchgate.net researchgate.net/publication/316529780_Dynamic_Contrast-Enhanced_Magnetic_Resonance_Imaging_of_Ocular_Melanoma_as_a_Tool_to_Predict_Metastatic_Potential

Dynamic Contrast-Enhanced Magnetic Resonance ... Conclusions: Dynamic contrast-enhanced magnetic resonance imaging has the potential to differentiate orbital melanomas with metastatic and ...

5. clinicalradiologyonline.net clinicalradiologyonline.net/article/S0009-9260(23)00499-3/fulltext

Diagnostic value of dynamic contrast enhancement ... The Ktrans and Kep values obtained by DCE-MRI were higher in malignant than in benign tumours, with a statistically significant (p<0.001 and p= ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4324575/

Parameters of Dynamic Contrast-Enhanced MRI as Imaging ... This study evaluated the value of morphological examination in conjunction with dynamic contrast-enhanced MRI (DCE-MRI) for more precise diagnosis of breast ...

7. journals.lww.com journals.lww.com/investigativeradiology/fulltext/2025/09000/first_in_human_safety,_tolerability,_efficacy,_and.3.aspx

First-in-Human Safety, Tolerability, Efficacy, and... The primary objective of the first-in-human (FIH) study was to evaluate the safety and tolerability of the manganese (Mn)-based contrast agent pegfosimer ...

8. mdpi.com mdpi.com/1422-0067/23/2/679

Dynamic Contrast-Enhanced Magnetic Resonance ... DCE-MRI has been widely employed in the clinic to detect tumor lesions and, in some cases, to monitor response to anti-cancer therapy [16,17]. DCE-MRI assesses ...