A Phase 1 interventional study of DeepGad in Artificial Intelligence and Deep Learning, sponsored by DeepMeds. Withdrawn. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by DeepMeds · Phase 1, Interventional, and Diagnostic
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.
This is the only study on the registry with DeepMeds as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Image quality
Image quality using a 5-point Likert scale covering 1 (none), 2 (poor), 3 (moderate), 4 (good), and 5(excellent) ratings
Time frame: 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.
Time frame: 1 Day After MRI session
Enhancement pattern
(a) no enhancement, (b) homogeneous enhancement, (c) heterogeneous enhancement, (d) ring enhancement, (e) linear enhancement, and (f) other enhancement.
Time frame: 1 Day After MRI session
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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