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Gadoquatrane-enhanced MRI for Body Imaging (Quanti OBR Trial)

Phase 3

Recruiting

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic gbcas

Awards & highlights

Quanti OBR Trial Summary

This trial aims to compare the safety and efficacy of gadoquatrane-enhanced MRI scans to plain-MRI scans in identifying health problems.

Who is the study for?

Adults needing a contrast-enhanced MRI for non-brain or spinal issues can join. They must be able to have two MRIs with different contrast agents and meet specific health criteria, like stable kidney function and no severe allergies to gadolinium-based agents. Women participating should not be pregnant or breastfeeding and must use contraception if of childbearing potential.Check my eligibility

What is being tested?

The trial is testing Gadoquatrane, a new MRI contrast agent that uses less gadolinium, against standard agents in patients with suspected body problems (excluding the central nervous system). Participants will receive both Gadoquatrane and a current agent in separate MRIs to compare effectiveness.See study design

What are the potential side effects?

Potential side effects may include allergic reactions similar to other gadolinium-based contrasts such as skin rash, itching, headache, nausea, dizziness or feeling hot. Unstable asthma patients are excluded due to increased risk of reaction.

Quanti OBR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic gbcas

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic gbcas

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic gbcas for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Visualization parameter contrast Enhancement assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICR

Visualization parameter delineation assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICR

Visualization parameter morphology assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICR

Secondary outcome measures

Confidence in diagnosis combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs by BICR and by Investigator

Diagnoses from combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs by the Investigator

Number of enhancing lesions seen on combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, by a BICR

+11 more

Quanti OBR Trial Design

2Treatment groups

Experimental Treatment

Group I: Gadoquatrane - Approved Macrocyclic GBCAExperimental Treatment4 Interventions

Participants will receive one intravenous injection of gadoquatrane during MRI in Period 1, followed by one intravenous injection of any approved macrocyclic GBCA during MRI in Period 2.

Group II: Approved Macrocyclic GBCA - GadoquatraneExperimental Treatment4 Interventions

Participants will receive one intravenous injection of any approved macrocyclic GBCA during MRI in Period 1, followed by one intravenous injection of gadoquatrane during MRI in Period 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gadoquatrane (BAY1747846)

2020

Completed Phase 2

~60

Gadobutrol

2020

Completed Phase 3

~250

Gadoteridol

2015

Completed Early Phase 1

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

BayerLead Sponsor

2,240 Previous Clinical Trials

25,332,387 Total Patients Enrolled

7 Trials studying Contrast Enhancement in Magnetic Resonance Imaging

2,220 Patients Enrolled for Contrast Enhancement in Magnetic Resonance Imaging

Media Library

Gadoquatrane - Approved Macrocyclic GBCA Clinical Trial Eligibility Overview. Trial Name: NCT05915728 — Phase 3

Contrast Enhancement in Magnetic Resonance Imaging Research Study Groups: Gadoquatrane - Approved Macrocyclic GBCA, Approved Macrocyclic GBCA - Gadoquatrane

Contrast Enhancement in Magnetic Resonance Imaging Clinical Trial 2023: Gadoquatrane - Approved Macrocyclic GBCA Highlights & Side Effects. Trial Name: NCT05915728 — Phase 3

Gadoquatrane - Approved Macrocyclic GBCA 2023 Treatment Timeline for Medical Study. Trial Name: NCT05915728 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What end-goals are researchers expecting to reach with this test?

"The primary outcome of this brief medical procedure will be evaluated by a blinded independent central reader (BICR) and assessed via visualization parameter delineation using unenhanced and combined pre-and post-gadolinium-based contrast agent MRI. This is measured on a 4 point scale, with 1 representing no or unclear delineation to 4 for clear and complete delineations. Secondary objectives include similar analysis of morphology also rated on a 3 point scale from poor to good evaluation as well as sensitivity for the detection of lesions across both pre-and post MRIs."

Answered by AI

Is this investigation still in the process of enrolling patients?

"According to clinicaltrials.gov, recruitment for this particular medical trial has ended as it was last updated on June 25th 2023. First posted on July 26th 2022, the study is no longer actively seeking participants; however, two additional trials are presently searching for volunteers."

Answered by AI

How many research centers are conducting the experiment?

"This study is being conducted through Halo Diagnostics, UC Irvine Medical Center, University of Connecticut Health Centre and 107 other sites across the United States. Specifically Indian Wells in California, Orange in Connecticut and Farmington in Illinois are involved."

Answered by AI

Are there any adverse effects associated with Gadoquatrane - Approved Macrocyclic GBCA for patients?

"The safety profile of Gadoquatrane - Approved Macrocyclic GBCA was assigned a score of 3 since this is a Phase 3 trial, indicating there are substantiated data points affirming the medication's efficacy and multiple validations vouching for its security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Any Known or Suspected Problems of the Body (Except Brain or Spinal Cord-related Problems)

2023. "A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Any Known or Suspected Problems of the Body (Except Brain or Spinal Cord-related Problems)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05915728.

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