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NCT06322342RECRUITINGIRB Ready

Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent

Sponsored by Reveal Pharmaceuticals Inc.

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 24 participants interested
4% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This Phase 2 clinical trial will study RVP-001, a new manganese-based MRI contrast agent, in people who are known to have gadolinium-enhancing central nervous system (CNS) lesions, for example brain tumors or multiple sclerosis. The goal of this study is to assess safety, efficacy, and pharmacokinetics of RVP-001 at three dose levels. The study will also compare RVP-001 imaging to gadolinium-based contrast agent (GBCA) imaging. A single dose of RVP-001 will be administered to each subject.

Who Can Participate

Inclusion Criteria

Adults of all sexes, aged 18-75 years 2. Patients with known enhancing CNS lesions, including but not limited to gliomas, meningiomas, glioblastomas, schwannomas, brain metastases, multiple sclerosis lesions, that are on an ongoing follow-up MRI schedule 3. Patients who have had a GBCA-enhanced MRI within the past 14 days which demonstrated focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors, focal inflammatory disorders) including at least one enhancing lesion of minimum 5 mm (long axis) 4. Acceptable renal function

Exclusion Criteria

Serious non-malignant disease that could compromise protocol objectives in the opinion of the investigator and/or the Sponsor 2. Body mass index (BMI) greater than 35 3. Patients with clinically significant cardiac disease 4. MRI incompatibility

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

24 participants

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Age Range

18 Years - 75 Years

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Gender

ALL

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Sponsor

Reveal Pharmaceuticals Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

New Haven

Connecticut

Location available
View New Haven location page
Unknown

Boston

Massachusetts

Location available
View Boston location page
Unknown

Boston

Massachusetts

Location available
View Boston location page
Unknown

Columbia

Missouri

Location available
View Columbia location page
Unknown

Durham

North Carolina

Location available
View Durham location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for I cannot determine a primary medical condition from the provided information. The study appears to be testing an MRI contrast agent, but no specific medical condition or patient population is indicated in the available data. Treatment in New Haven?

Join others in Connecticut exploring innovative treatment options through clinical research

I cannot determine a primary medical condition from the provided information. The study appears to be testing an MRI contrast agent, but no specific medical condition or patient population is indicated in the available data. Treatment Options in New Haven, Connecticut

If you're searching for I cannot determine a primary medical condition from the provided information. The study appears to be testing an MRI contrast agent, but no specific medical condition or patient population is indicated in the available data. treatment in New Haven, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in New Haven, Boston, Boston and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with I cannot determine a primary medical condition from the provided information. The study appears to be testing an MRI contrast agent, but no specific medical condition or patient population is indicated in the available data.. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Connecticut
Now Enrolling
Up to 24 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for I cannot determine a primary medical condition from the provided information. The study appears to be testing an MRI contrast agent, but no specific medical condition or patient population is indicated in the available data.?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for I cannot determine a primary medical condition from the provided information. The study appears to be testing an MRI contrast agent, but no specific medical condition or patient population is indicated in the available data.

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This I cannot determine a primary medical condition from the provided information. The study appears to be testing an MRI contrast agent, but no specific medical condition or patient population is indicated in the available data. Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06322342. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.