Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2022 Apr;31(4):546-554.
doi: 10.1089/jwh.2020.8892. Epub 2021 Jul 8.

Uterine and Fibroid Imaging Analysis from the FIRSTT Study

Shannon K Laughlin-Tommaso  1 , Krzysztof R Gorny  2 , Gina K Hesley  2 , Lisa E Vaughan  3 , David A Woodrum  2 , Maureen A Lemens  1 , Elizabeth A Stewart  1
Affiliations
Randomized Controlled Trial

Uterine and Fibroid Imaging Analysis from the FIRSTT Study

Shannon K Laughlin-Tommaso et al. J Womens Health (Larchmt). 2022 Apr.

Abstract

Background: Women with uterine fibroids often seek uterine-preserving treatments, rather than hysterectomy. Imaging-defined endpoints following nonsurgical treatments for fibroids are limited. Materials and Methods: Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT), a randomized controlled trial of uterine artery embolization (UAE) versus magnetic resonance imaging-guided focused ultrasound surgery (MRgFUS), enrolled premenopausal women with symptomatic uterine fibroids. In this subanalysis, we report imaging results up to 36 months after UAE or MRgFUS. Magnetic resonance imaging (MRI) was performed at baseline for all women and during the 36 months after treatment if they did not meet other study endpoints. The main outcome of this subanalysis was fibroid volume reduction (defined both in terms of total fibroid load and volume of the largest fibroid), uterine volume reduction, and nonperfused volume. Results: During 2010-2014, 25 of the 37 women who were randomized and treated at Mayo Clinic had a 24-month follow-up MRI (11 UAE; 14 MRgFUS); among these women, 15 (7 UAE and 8 MRgFUS) had a 36-month follow-up MRI. Average age for the cohort was 44.1 (standard deviation, SD = 4.4) years. Nine patients had a second fibroid procedure by 36 months (seven in the MRgFUS arm and two in UAE arm). Median total fibroid load reduction was ∼50% in both treatment arms at both 24- and 36-month follow-up. Volume of the largest fibroid decreased more in the MRgFUS arm, whereas uterine volume decreased more in the UAE arm (neither reached statistical significance). At 24 months, median nonperfused volume was higher in the UAE arm (92%) than the MRgFUS arm (10%). Conclusions: Similar fibroid volume reduction was seen for the MRgFUS and UAE treatments in this comparative effectiveness study. Nonperfused volume 24 months after the procedure was higher in the UAE arm than in the MRgFUS arm. Clinical Trial Registration Number: NCT00995878, clinicaltrials.gov.

Keywords: focused ultrasound; leiomyoma; magnetic resonance imaging; randomized controlled trial; uterine artery embolization; uterine fibroid.

PubMed Disclaimer

Conflict of interest statement

S.K.L.-T. has received royalties from UpToDate and grant from InSightec outside of the submitted work. E.A.S. reports consulting from AbbVie, Bayer, ObsEva, and Myovant related to uterine fibroids, and has received royalties from UpToDate and payments for the development of educational content from the Med Learning Group, PER, Massachusetts Medical Society and Peer View. G.K.H., and K.R.G., report grants from InSightec outside the submitted work. L.E.V., D.A.W., and M.A.L. have nothing to disclose.

Figures

FIG. 1.
FIG. 1.
Cohort diagram for the FIRSTT Study Imaging Analysis. aFull MRI imaging was not available from outside institutions for analysis. bTwo MRgFUS patients had hysterectomies at 12 months after initial procedure but had completed follow-up MRI and contribute to the n = 14 with MRI follow-up up to 24 months.
See this image and copyright information in PMC

References

    1. Stewart EA, Laughlin-Tommaso SK, Catherino WH, Lalitkumar S, Gupta D, Vollenhoven B. Uterine fibroids. Nat Rev Dis Primers 2016;2:16043. - PubMed
    1. Baird DD, Garrett TA, Laughlin SK, Davis B, Semelka RC, Peddada SD. Short-term change in growth of uterine leiomyoma: Tumor growth spurts. Fertil Steril 2011;95:242–246. - PMC - PubMed
    1. Stewart EA, Nicholson WK, Bradley L, Borah BJ. The burden of uterine fibroids for African-American women: Results of a national survey. J Womens Health (Larchmt) 2013;22:807–816. - PMC - PubMed
    1. Laughlin-Tommaso S, Barnard EP, AbdElmagied AM, et al. . FIRSTT study: Randomized controlled trial of uterine artery embolization vs focused ultrasound surgery. Am J Obstet Gynecol 2019;220:174 e1–174 e13. - PMC - PubMed
    1. Kim HS, Baik JH, Pham LD, Jacobs MA. MR-guided high-intensity focused ultrasound treatment for symptomatic uterine leiomyomata: Long-term outcomes. Acad Radiol 2011;18:970–976. - PMC - PubMed

Publication types

Associated data