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

NCT06462924 | Withdrawn Phase 1

• 1 other identifier: DG53024
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Artificial Intelligence; Deep Learning

Outcome Measures

Primary Outcomes (2)

• Image quality

  Image quality using a 5-point Likert scale covering 1 (none), 2 (poor), 3 (moderate), 4 (good), and 5(excellent) ratings

  1 Day After MRI session

• Vessel conspicuity

  (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.

  1 Day After MRI session

Secondary Outcomes (1)

• Enhancement pattern

  1 Day After MRI session

Study Arms (1)

DeepGad

EXPERIMENTAL

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.

Device: DeepGad

Interventions

DeepGad DEVICE

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.

DeepGad

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.,
• 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),
• no clinical contraindications to imaging prolongation (i.e., emergency, poor patient condition).

You may not qualify if:

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

Sponsors & Collaborators

• DeepMeds: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 17, 2024
• Study Start: August 30, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 15, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share