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Feasibility of Gadolinium Contrast Reduced Brain MRI: the Potential of Deep Learning

Feasibility of Gadolinium Contrast Reduced Brain MRI: the Potential of Deep Learning

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06462924
Enrollment
0
Registered
2024-06-17
Start date
2024-08-30
Completion date
2024-09-15
Last updated
2025-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artificial Intelligence, Deep Learning

Brief summary

MRI scans were performed using 3 different 1.5T scanners with an eight-channel head coils. Following a 3D pre-contrast T1w scan, a low-dose contrast-enhanced 3D T1w scan was obtained using 20% (0.02 mmol/kg) of the standard dosage of gadoterate meglumine. The subjects were immediately administered the remaining 80% (0.08 mmol/kg) of the contrast agent to reach the standard dose of 0.1 mmol/kg, which served as a training ground truth for further quantitative assessment. All three acquisitions were performed during a single imaging session, with no additional gadolinium dose administered above the standard protocol.

Interventions

DEVICEDeepGad

Using the pre-contrast and low-dose Contrast-Enhanced Magnetic Resonance (CE-MRI) images as input and the true full-dose CE-MRI images as the ground truth. the Cycle GAN deep network (DeepGad), was trained to reconstruct the full-dose CE-MRI images from low-dose CE-MRI images.

Sponsors

DeepMeds
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

1. Clinical indications for imaging with a contrast-enhanced 3D-T1w MRI sequence including tumor suspicion, postoperative tumor follow-up, multiple sclerosis, routine brain imaging, etc., 2. no plan for dynamic contrast administration or deviation from the standard dose of 0.1 mmol/kg body weight (e.g., sella imaging, magnetic resonance angiography), 3. no clinical contraindications to imaging prolongation (i.e., emergency, poor patient condition).

Exclusion criteria

1. prominent image artifacts, 2. incomplete study sequences (e.g., early termination) 3. errors related to contrast agent administration.

Design outcomes

Primary

MeasureTime frameDescription
Image quality1 Day After MRI sessionImage quality using a 5-point Likert scale covering 1 (none), 2 (poor), 3 (moderate), 4 (good), and 5(excellent) ratings
Vessel conspicuity1 Day After MRI session(0) no normal vessels observed, (1) significant decrease in conspicuity with potential impact on diagnosis, (2) mild decrease in conspicuity with unlikely impact on diagnosis, (3) normal conspicuity, (4) mild increase in conspicuity with unlikely impact on diagnosis, and (5) significant increase in conspicuity with potential impact on diagnosis.

Secondary

MeasureTime frameDescription
Enhancement pattern1 Day After MRI session(a) no enhancement, (b) homogeneous enhancement, (c) heterogeneous enhancement, (d) ring enhancement, (e) linear enhancement, and (f) other enhancement.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026