Safety and Diagnostic Efficacy of Gadobenate Dimeglumine in MRI of the Brain and Spine of Neonates and Infants

D.S. Enterline; K.W Martin; H.A Parmar; F.M Triulzi; C. Colosimo

doi:10.3174/ajnr.A6319

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Fig 1.
MR imaging in a 4.3-month-old infant with cerebellar pilocytic astrocytoma shows a large intra-axial mass, which is hyperintense on FLAIR (A) and T2-weighted (B) images with surrounding edema. The lesion is hypointense on the T1-weighted precontrast image (C) and shows heterogeneous-but-avid postcontrast enhancement (D) after contrast administration (0.08 mmol/kg of gadobenate dimeglumine [1 mL] administered as a manual bolus). Also note marked obstructive hydrocephalus with enlarged bilateral temporal horns.
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Fig 2.
MR imaging in a 2.3-month-old infant with desmoplastic medulloblastoma shows a large multinodular intra-axial mass, which is isointense on FLAIR (A) and T2-weighted (B) images with mild surrounding edema. The lesion is slightly hypointense on the T1-weighted precontrast image (C) and shows moderate homogeneous enhancement (D) after contrast administration (0.07 mmol/kg of gadobenate dimeglumine, 0.8 mL administered as a manual bolus). Also noted is obstructive hydrocephalus with extensive periventricular interstitial edema.
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Fig 3.
MR imaging in a 15-month-old girl with known subacute infarctions. Axial and sagittal T1-weighted images acquired before (A and B) and after (C and D) contrast administration (0.08 mmol/kg gadobenate dimeglumine [1.5 mL] administered as a manual bolus). Extensive gyral enhancement in the cerebral hemispheres is clearly demonstrated on postcontrast images.

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Table 1:

Patient demographic characteristics and details regarding type of MR examination, exposure to gadobenate dimeglumine, and sedation during examination

Demographic	Overall	0 to <1 Month	1 to <6 Months	6 to <12 Months	12–24 Months
No. of subjects	90	13	23	19	35
Male/female	48:42	4:9	11:12	16:3	17:18
Age (mo)
Mean	9.7 ± 7.5	0.3 ± 0.3	3.0 ± 1.3	9.1 ± 1.8	17.9 ± 3.1
Range	0.1–23.3	0.1–0.8	1.1–5.6	6.0–11.5	12.2–23.3
Weight (Kg)
Mean	7.9 ± 3.3	3.5 ± 0.7	5.4 ± 1.5	8.6 ± 1.8	10.8 ± 2.0
Range	2.3–16.3	2.3–4.8	2.6–9.6	5.2–12.1	7.4–16.3
Height (cm)
Mean	68.4 ± 13.5	46.4 ± 6.7	59.4 ± 6.4	68.7 ± 5.2	81.0 ± 5.8
Range	32–91	32–51	47–71	61–76	70–91
Type of examination
Brain	83	12	23	17	31
Spine	7	1	0	2	4
Dose (mmol/kg)
Mean	0.084 ± 0.015	0.092 ± 0.025	0.089 ± 0.018	0.085 ± 0.01	0.078 ± 0.006
Range	0.07–0.13	0.07–0.13	0.07–0.13	0.07–0.10	0.07–0.10
Sedation/anesthesia^{^a}
Yes	72	7	16	15	34
No	7	3	3	1	0
NA	11	3	4	3	1

Note:—NA indicates not available.
↵a Patients may have received >1 drug for sedation.

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Table 2:

Relevant medical history of evaluated patients^{^a}

History
No. of patients included	n = 90
No. of patients with at least 1 finding	71 (78.9)
No. of patients by finding
Oncology	23 (25.6)
Metabolic	1 (1.1)
Congenital	6 (6.7)
Other	48 (53.3)
Cerebrovascular	23 (25.6)
Hemorrhagic	3 (3.3)
Infarct	3 (3.3)
Ischemic	13 (14.4)
Vascular	4 (4.4)
Hydrocephalus	3 (3.3)
Inflammatory/Infectious	15 (16.7)
Injury	7 (7.8)
Seizure	4 (4.4)
Other findings	6 (6.7)

↵a Numbers add up to >100% because a patient may have findings in >1 category. Data in parentheses are percentages of total [n = 90] patients.

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Table 3:

Serum creatinine values

Demographic	Overall	0 to <1 Month	1 to <6 Months	6 to <12 Months	12–24 Months
No. of subjects	61	12	16	11	22
SCr (mg/mL)
Mean	0.3 ± 0.19	0.5 ± 0.23	0.3 ± 0.25	0.2 ± 0.07	0.3 ± 0.07
Range	0.1–1.2	0.2–0.9	0.1–1.2	0.1–0.4	0.2–0.4
eGFR (mL/min/1.73m²)
Mean	131.7 ± 60.3	59.3 ± 31.7	92.4 ± 43.2	150.4 ± 18.3	176.3 ± 47.2
Range	17.6–255.6	24.0–114.8	17.6–153.9	114.0–168.8	99.0–255.6

Note:—SCr indicates serum creatinine; eGFR, estimated glomerular filtration rate.

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Table 4:

Gadobenate dimeglumine dose distribution

Volume/Dose Classes		No. of Patients
Volume Administered (mL/kg)	Dose Administered (mmol/kg)	No. of Patients
≤0.14	≤0.07	2
0.142–0.15	0.071–0.075	25
0.152–0.16	0.076–0.08	25
0.162–0.18	0.081–0.09	20
0.182–0.2	0.091–0.1	7
0.202–0.264	0.101–0.132	11
Total		90

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Table 5:

Evaluation of diagnostic performance on combined pre- and postcontrast MR images relative to precontrast images alone

End Point	Reader	Precontrast (n = 89)	Pre- + Postcontrast (n = 89)	P Value^{^a}
Tumor vs nontumor	1	75 (84.3%)	84 (94.4%)	.003
	2	67 (75.3%)	81 (91.0%)	<.001
	3	78 (87.6%)	82 (92.1%)	.046
Specific diagnosis	1	52 (58.4%)	65 (73.0%)	.003
	2	47 (52.8%)	63 (70.8%)	<.001
	3	50 (56.2%)	59 (66.3%)	.02

↵a McNemar test.

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Table 6:

Comparison of diagnostic performance on combined pre- and postcontrast images in patients administered gadobenate dimeglumine at doses of ≤0.08 mmol/kg body weight compared with doses >0.08 mmol/kg body weight

End Point	Reader	≤0.08 mmol/kg (n = 52)	>0.08 mmol/kg (n = 37)	P Value^{^a}
Tumor vs nontumor	1	50 (96.2%)	34 (91.9%)	.645
	2	45 (86.5%)	36 (97.3%)	.133
	3	47 (90.4%)	35 (94.6%)	.695
Specific diagnosis	1	40 (76.9%)	25 (67.6%)	.344
	2	38 (73.1%)	25 (67.6%)	.64
	3	35 (67.3%)	24 (64.9%)	.824