Uterine leiomyomas: MR imaging-guided focused ultrasound surgery - Results of different treatment protocols

Fiona M. Fennessy, Clare M. Tempany, Nathan J. McDannold, Minna J. So, Gina Hesley, Bobbie Gostout, Hyun S. Kim, George A. Holland, Dennis A. Sarti, Kullervo Hynynen, Ferenc A. Jolesz, Elizabeth A Stewart

Research output: Contribution to journalArticle

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Abstract

Purpose: To prospectively assess patient response (after 12 months) to magnetic resonance (MR) imaging-guided focused ultrasound surgery in treatment of uterine leiomyomas by using two treatment protocols. Materials and Methods: This prospective clinical trial was approved by institutional review boards and was HIPAA compliant. After giving informed consent, patients with symptomatic leiomyomas were consecutively enrolled and treated at one of five U.S. centers by using an original or a modified protocol. Outcomes were assessed with the symptom severity score (SSS) obtained at baseline and 3, 6, and 12 months after treatment. Adverse events (AEs) were recorded. Statistical analysis included Student t test, Fisher exact test, analysis of covariance, Spearman correlation, and logistic regression. Results: One hundred sixty patients had a mean SSS of 62.1 ± 16.3 (standard deviation) at baseline, which decreased to 35.5 ± 19.5 at 3 months (P < .001) and to 32.3 ± 19.8 at 6 months (P < .001) and was 32.7 ± 21.0 at 12 months (P < .001). Ninety-six patients (mean age, 46.0 years ± 4.6) were treated with an original protocol, and 64 (mean age, 45.9 years ± 3.9) were treated with a modified protocol. Patients in the modified group had a significantly greater SSS decrease at 3 months (P = .037) than those in the original group, and 73% of those in the original group and 91% of those in the modified group reported a significant decrease in SSS (of 10 points or greater) at 12 months. No serious AEs were recorded. Fewer AEs were reported in the modified group than in the original group (25% vs 13% reporting no event). Of evaluable patients, fewer in the modified group chose alternative treatment (28%) than in the original group (37%). Conclusion: MR imaging-guided focused ultrasound surgery results in symptomatic improvement, sustained to 12 months after treatment. Treatment with a modified protocol results in greater clinical effectiveness and fewer AEs.

Original languageEnglish (US)
Pages (from-to)885-893
Number of pages9
JournalRadiology
Volume243
Issue number3
DOIs
StatePublished - Jun 2007

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Leiomyoma
Clinical Protocols
Magnetic Resonance Imaging
Health Insurance Portability and Accountability Act
Therapeutics
Research Ethics Committees
Informed Consent
Logistic Models
Clinical Trials
Students

ASJC Scopus subject areas

  • Radiological and Ultrasound Technology

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Uterine leiomyomas : MR imaging-guided focused ultrasound surgery - Results of different treatment protocols. / Fennessy, Fiona M.; Tempany, Clare M.; McDannold, Nathan J.; So, Minna J.; Hesley, Gina; Gostout, Bobbie; Kim, Hyun S.; Holland, George A.; Sarti, Dennis A.; Hynynen, Kullervo; Jolesz, Ferenc A.; Stewart, Elizabeth A.

In: Radiology, Vol. 243, No. 3, 06.2007, p. 885-893.

Research output: Contribution to journalArticle

Fennessy, FM, Tempany, CM, McDannold, NJ, So, MJ, Hesley, G, Gostout, B, Kim, HS, Holland, GA, Sarti, DA, Hynynen, K, Jolesz, FA & Stewart, EA 2007, 'Uterine leiomyomas: MR imaging-guided focused ultrasound surgery - Results of different treatment protocols', Radiology, vol. 243, no. 3, pp. 885-893. https://doi.org/10.1148/radiol.2433060267
Fennessy, Fiona M. ; Tempany, Clare M. ; McDannold, Nathan J. ; So, Minna J. ; Hesley, Gina ; Gostout, Bobbie ; Kim, Hyun S. ; Holland, George A. ; Sarti, Dennis A. ; Hynynen, Kullervo ; Jolesz, Ferenc A. ; Stewart, Elizabeth A. / Uterine leiomyomas : MR imaging-guided focused ultrasound surgery - Results of different treatment protocols. In: Radiology. 2007 ; Vol. 243, No. 3. pp. 885-893.
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title = "Uterine leiomyomas: MR imaging-guided focused ultrasound surgery - Results of different treatment protocols",
abstract = "Purpose: To prospectively assess patient response (after 12 months) to magnetic resonance (MR) imaging-guided focused ultrasound surgery in treatment of uterine leiomyomas by using two treatment protocols. Materials and Methods: This prospective clinical trial was approved by institutional review boards and was HIPAA compliant. After giving informed consent, patients with symptomatic leiomyomas were consecutively enrolled and treated at one of five U.S. centers by using an original or a modified protocol. Outcomes were assessed with the symptom severity score (SSS) obtained at baseline and 3, 6, and 12 months after treatment. Adverse events (AEs) were recorded. Statistical analysis included Student t test, Fisher exact test, analysis of covariance, Spearman correlation, and logistic regression. Results: One hundred sixty patients had a mean SSS of 62.1 ± 16.3 (standard deviation) at baseline, which decreased to 35.5 ± 19.5 at 3 months (P < .001) and to 32.3 ± 19.8 at 6 months (P < .001) and was 32.7 ± 21.0 at 12 months (P < .001). Ninety-six patients (mean age, 46.0 years ± 4.6) were treated with an original protocol, and 64 (mean age, 45.9 years ± 3.9) were treated with a modified protocol. Patients in the modified group had a significantly greater SSS decrease at 3 months (P = .037) than those in the original group, and 73{\%} of those in the original group and 91{\%} of those in the modified group reported a significant decrease in SSS (of 10 points or greater) at 12 months. No serious AEs were recorded. Fewer AEs were reported in the modified group than in the original group (25{\%} vs 13{\%} reporting no event). Of evaluable patients, fewer in the modified group chose alternative treatment (28{\%}) than in the original group (37{\%}). Conclusion: MR imaging-guided focused ultrasound surgery results in symptomatic improvement, sustained to 12 months after treatment. Treatment with a modified protocol results in greater clinical effectiveness and fewer AEs.",
author = "Fennessy, {Fiona M.} and Tempany, {Clare M.} and McDannold, {Nathan J.} and So, {Minna J.} and Gina Hesley and Bobbie Gostout and Kim, {Hyun S.} and Holland, {George A.} and Sarti, {Dennis A.} and Kullervo Hynynen and Jolesz, {Ferenc A.} and Stewart, {Elizabeth A}",
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T1 - Uterine leiomyomas

T2 - MR imaging-guided focused ultrasound surgery - Results of different treatment protocols

AU - Fennessy, Fiona M.

AU - Tempany, Clare M.

AU - McDannold, Nathan J.

AU - So, Minna J.

AU - Hesley, Gina

AU - Gostout, Bobbie

AU - Kim, Hyun S.

AU - Holland, George A.

AU - Sarti, Dennis A.

AU - Hynynen, Kullervo

AU - Jolesz, Ferenc A.

AU - Stewart, Elizabeth A

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N2 - Purpose: To prospectively assess patient response (after 12 months) to magnetic resonance (MR) imaging-guided focused ultrasound surgery in treatment of uterine leiomyomas by using two treatment protocols. Materials and Methods: This prospective clinical trial was approved by institutional review boards and was HIPAA compliant. After giving informed consent, patients with symptomatic leiomyomas were consecutively enrolled and treated at one of five U.S. centers by using an original or a modified protocol. Outcomes were assessed with the symptom severity score (SSS) obtained at baseline and 3, 6, and 12 months after treatment. Adverse events (AEs) were recorded. Statistical analysis included Student t test, Fisher exact test, analysis of covariance, Spearman correlation, and logistic regression. Results: One hundred sixty patients had a mean SSS of 62.1 ± 16.3 (standard deviation) at baseline, which decreased to 35.5 ± 19.5 at 3 months (P < .001) and to 32.3 ± 19.8 at 6 months (P < .001) and was 32.7 ± 21.0 at 12 months (P < .001). Ninety-six patients (mean age, 46.0 years ± 4.6) were treated with an original protocol, and 64 (mean age, 45.9 years ± 3.9) were treated with a modified protocol. Patients in the modified group had a significantly greater SSS decrease at 3 months (P = .037) than those in the original group, and 73% of those in the original group and 91% of those in the modified group reported a significant decrease in SSS (of 10 points or greater) at 12 months. No serious AEs were recorded. Fewer AEs were reported in the modified group than in the original group (25% vs 13% reporting no event). Of evaluable patients, fewer in the modified group chose alternative treatment (28%) than in the original group (37%). Conclusion: MR imaging-guided focused ultrasound surgery results in symptomatic improvement, sustained to 12 months after treatment. Treatment with a modified protocol results in greater clinical effectiveness and fewer AEs.

AB - Purpose: To prospectively assess patient response (after 12 months) to magnetic resonance (MR) imaging-guided focused ultrasound surgery in treatment of uterine leiomyomas by using two treatment protocols. Materials and Methods: This prospective clinical trial was approved by institutional review boards and was HIPAA compliant. After giving informed consent, patients with symptomatic leiomyomas were consecutively enrolled and treated at one of five U.S. centers by using an original or a modified protocol. Outcomes were assessed with the symptom severity score (SSS) obtained at baseline and 3, 6, and 12 months after treatment. Adverse events (AEs) were recorded. Statistical analysis included Student t test, Fisher exact test, analysis of covariance, Spearman correlation, and logistic regression. Results: One hundred sixty patients had a mean SSS of 62.1 ± 16.3 (standard deviation) at baseline, which decreased to 35.5 ± 19.5 at 3 months (P < .001) and to 32.3 ± 19.8 at 6 months (P < .001) and was 32.7 ± 21.0 at 12 months (P < .001). Ninety-six patients (mean age, 46.0 years ± 4.6) were treated with an original protocol, and 64 (mean age, 45.9 years ± 3.9) were treated with a modified protocol. Patients in the modified group had a significantly greater SSS decrease at 3 months (P = .037) than those in the original group, and 73% of those in the original group and 91% of those in the modified group reported a significant decrease in SSS (of 10 points or greater) at 12 months. No serious AEs were recorded. Fewer AEs were reported in the modified group than in the original group (25% vs 13% reporting no event). Of evaluable patients, fewer in the modified group chose alternative treatment (28%) than in the original group (37%). Conclusion: MR imaging-guided focused ultrasound surgery results in symptomatic improvement, sustained to 12 months after treatment. Treatment with a modified protocol results in greater clinical effectiveness and fewer AEs.

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