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

Phase 1

Withdrawn

• Conditions: Deep Learning; Artificial Intelligence
• Interventions: Device: DeepGad

• Registration Number: NCT06462924
• Lead Sponsor: DeepMeds

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-06-11
• Study First Posted: 2024-06-17
• Study Start: 2024-08-30
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DeepGad	DeepGad	The dataset comprises a total of 500 patients, with 300 patients used for model training and 200 patients reserved for model testing. Each patient had approximately 350 2D brain slices of the coregistered 3D volumes excluding the five slices at the base and five slices at the top of the acquired volume due to their low signal-to-noise ratio (SNR). For robustness and to avoid overfitting, standard DL data augmentation techniques consisting of eight types of transformations were applied to each case in the training set.

Primary Outcome Measures

Name	Time	Method
Vessel conspicuity	1 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.
Image quality	1 Day After MRI session	Image quality using a 5-point Likert scale covering 1 (none), 2 (poor), 3 (moderate), 4 (good), and 5(excellent) ratings

Secondary Outcome Measures

Name	Time	Method
Enhancement pattern	1 Day After MRI session	(a) no enhancement, (b) homogeneous enhancement, (c) heterogeneous enhancement, (d) ring enhancement, (e) linear enhancement, and (f) other enhancement.