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

Artificial Intelligence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06462924
• Other study ID #: DG53024
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: July 30, 2024

Study information

• Verified date: June 2024
• Source: DeepMeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 101
• Est. completion date: July 30, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Artificial Intelligence
• Deep Learning

Intervention

Device:
• DeepGad
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
DeepMeds

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Enhancement pattern	(a) no enhancement, (b) homogeneous enhancement, (c) heterogeneous enhancement, (d) ring enhancement, (e) linear enhancement, and (f) other enhancement.	1 Day After MRI session