MR Image Synthesis With Low Gadobutrol Dose and AI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-16

Study Completion Date

2025-08-15

Brief Summary

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Study 22403 is a Phase 1 / Proof of Concept exploratory investigation to assess the non-inferiority of low dose gadobutrol and SubtleGAD™, a software medical device using an Artificial Intelligence (AI) deep learning-based method to enhance the contrast signal from images acquired with low dose administration of gadobutrol (GAD) contrast. The primary objective is to demonstrate noninferiority of synthesized Central Nervous System (CNS) magnetic resonance (MR) images for 1 or 2 different gadobutrol-enhanced low-dose groups (0.01mmol/kg, and0.025 mmol/kg) compared to gadobutrol-enhanced CNS MR images at a standard dose of 0.1 mmol/kg. This investigation is a prospective, randomized, open label, multi-center study with blinded reads in participants with known or highly suspected CNS pathology. There will be at least 60 participants enrolled (30 per study arm). SubtleGAD will be used as a post-processing tool, prior to blinded read assessment of MR images acquired in either arm of the study.

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Detailed Description

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Conditions

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Enhancing Brain Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two interventional groups: Group A: 0.01 mmol/kg GV, Group B: 0.025 mmol/kg GV. Both groups also receive GV standard dose (0.1 mmol/kg) that serves as the clinical image set for the participant and as comparator.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group A (10% dose GV)

Each participant will receive a Standard dose gadobutrol (0.1 mmol/kg) in Period 1 and 10% dose gadobutrol (0.01 mmol/kg) in Period 2. During study Period 1, each participant will receive gadobutrol as a single intravenous (IV) administration at the standard dose for contrast-enhanced MRI followed by study Period 2 where a single IV low dose (10% dose) of gadobutrol will be administered. There will be a washout period of at least 72 hours but less than 15 days between the two periods. The individual study duration will therefore range from 4 to 15 days.

Group Type ACTIVE_COMPARATOR

SubtleGAD

Intervention Type DEVICE

SubtleGAD is an image processing software developed to enhance MR images acquired with low dose gadobutrol.

Gadobutrol

Intervention Type DRUG

Gadavist is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients including term neonates to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.

Group B (25% dose GV)

Each participant will receive a Standard dose gadobutrol (0.1 mmol/kg) in Period 1 and Study Period 2: 25% dose gadobutrol (0.025 mmol/kg) in Period 2. During study Period 1, each participant will receive gadobutrol as a single intravenous (IV) administration at the standard dose for contrast-enhanced MRI followed by study Period 2 where a single IV low dose (25% dose) of gadobutrol will be administered. There will be a washout period of at least 72 hours but less than 15 days between the two periods. The individual study duration will therefore range from 4 to 15 days.

Group Type ACTIVE_COMPARATOR

SubtleGAD

Intervention Type DEVICE

SubtleGAD is an image processing software developed to enhance MR images acquired with low dose gadobutrol.

Gadobutrol

Intervention Type DRUG

Gadavist is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients including term neonates to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.

Interventions

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SubtleGAD

SubtleGAD is an image processing software developed to enhance MR images acquired with low dose gadobutrol.

Intervention Type DEVICE

Gadobutrol

Gadavist is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients including term neonates to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.

Intervention Type DRUG

Other Intervention Names

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Gadavist Injection

Eligibility Criteria

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Inclusion Criteria

1. At the time of signing the informed consent at least 18 years of age and less than or equal to 89 years of age.
2. Have known or highly suspected brain lesions referred for contrast-enhanced MRI of the CNS.
3. Have an estimated glomerular filtration rate (eGFR) value ≥ 60 mL/min/1.73m\^2.
4. Be fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA) as applicable, and being capable and willing to consent to participate.

Exclusion Criteria

1. Considered clinically unstable or has a concomitant/intercurrent condition that would not allow participation in the study.
2. Diagnoses of multiple sclerosis or other disease process that is expected to change its enhancement pattern in the time period of the follow-up.
3. Brain pathology or abnormalities that are not considered lesions.
4. Any contraindication for MRI procedure or gadobutrol administration.
5. Has severe cardiovascular disease.
6. Is expected or is scheduled to have a change in any treatment or procedure between the two study periods that may alter image comparability.
7. Is scheduled or is likely to require a biopsy or any interventional therapeutic procedure from the first study MRI up to 24 hours after the second study MRI.
8. Women currently lactating, pregnant, or planning on becoming pregnant during the study.
9. Women of childbearing potential with a positive urine pregnancy test within 24 hours before either gadobutrol administration.
10. Receipt of any gadolinium-based contrast agent \<72 hours prior to the study MRIs.
11. Participants with acute kidney injury.

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No