Effects of a microbubble ultrasound contrast agent on high-intensity focused ultrasound for uterine fibroids: a randomised controlled trial

Figures & data

Table 1. Contributing factors and group assignments.

	Treatment time
Drug	6 min (a1)	10 min (a2)
SonoVue (b1)	a1b1 (Group A)	a2b1 (Group B)
Saline (b2)	a1b2 (Group C)	a2b2 (Group D)

Figure 1. A 45-year-old patient with an 8.7 × 8.5 × 8.3 cm uterine fibroid and the significant grey-scale change during HIFU treatment. (A) Before HIFU treatment, ultrasound showed a hypoechoic fibroid (arrow). (B) Immediately after HIFU treatment, ultrasound showed a lumpy grey-scale change in the treatment area (arrow). (C) Before HIFU treatment, contrast-enhanced ultrasound showed the tumour perfusion area (arrow). (D) Immediately after HIFU treatment, contrast-enhanced ultrasound showed no enhancement surrounding the fibroid (arrow), indicating complete ablation. (E) Pre-treatment enhanced T1-weighted MRI showed tumour perfusion (arrow). (F) Post-treatment enhanced T1-weighted MRI showed a small area of enhancement along the tumour edges, with an ablation rate of 94% (arrow).

Table 2. General information for thefour groups (X¯ ± S).

Group	Group A (n = 30)	Group B (n = 30)	Group C (n = 30)	Group D (n = 30)	F/χ^2	p
Age (years)	40.3 ± 6.7	40.1 ± 4.7	40.3 ± 5.9	42.1 ± 4.8	0.083	0.489
Maximum tumour diameter (mm)	53.6 ± 17.3	50.4 ± 13.3	54.3 ± 16.0	57.1 ± 16.6	9.345	0.390
Tumour volume (cm^3)	79.6 ± 81.8	58.7 ± 41.8	66.3 ± 49.9	81.5 ± 98.3	1.435	0.697
Location of tumour (front/rear/side/bottom)	15/7/5/3	7/15/4/4	16/7/5/2	9/10/9/2	12.950	0.165
MRI signal (high/iso/low)	4/3/23	8/3/19	7/4/19	9/4/17	3.260	0.776

Table 3. Comparison of the treatment outcomes among the four groups.

Group	Group A (n = 30)	Group B (n = 30)	Group C (n = 30)	Group D (n = 30)	F
					Time	SonoVue	Interaction
Treatment time (min)	34.5 ± 19.3	51.2 ± 23.1	77.3 ± 47.2	71.4 ± 29.2	6.389*	37.955*	4.564*
Sonication time (s)	358.5 ± 240.7	476.9 ± 195.1	733.9 ± 428.1	687.2 ± 314.6	4.335*	33.982*	4.107*
Intensity of treatment (s/h)	597.3 ± 111.5	587.0 ± 103.3	596.6 ± 132.6	577.0 ± 111.6	0.507	0.065	0.048
Non-perfused volume ratio (cm^3)	69.8 ± 77.1	48.6 ± 37.0	48.8 ± 39.6	63.7 ± 89.2	0.206	0.273	1.280

* p < 0.05.

Table 4. Comparison of the treatment outcomes among the four groups.

Group	Group A (n = 30)	Group B (n = 30)	Group C (n = 30)	Group D (n = 30)	χ^2	p
Rate of significant grey-scale change, n (%)	19 (55.9)	8 (23.5)	4 (11.8)	5 (16.7)	22.540	0.000
Time to significant grey-scale change (s)	195.3 ± 178.0	259.5 ± 252.9	431.0 ± 163.1	368.0 ± 303.3	4.952	0.175
NPV ratio (%)	94.2 ± 10.6^♦	81.9 ± 18.1	72.8 ± 25.4	74.9 ± 21.3	20.729	0.000

♦ p < 0.05, group A vs. the other three groups; NPV: non-perfused volume ratio.

Table 5. Comparison of intra-procedure and post-procedure adverse effects.

Group	Group A (n = 30)	Group B (n = 30)	Group C (n = 30)	Group D (n = 30)	χ^2	p
Rate of intra-procedure adverse effects	23 (76.7%)	27 (90%)	25 (83.3%)	25 (83.3%)	2.791	0.425
Rate of post-HIFU adverse effects	11 (36.7%)	11 (36.7%)	10 (33.3%)	12 (40.0%)	0.193	0.979