Uterine FibroidsPhase 4NCT00159328
Efficacy Study of Magnetic Resonance (MR) Guided Focused Ultrasound in the Treatment of Large Fibroids
A Phase 4 study testing Magnetic Resonance Guided Focused Ultrasound in people with Uterine Fibroids, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether ablation of uterine fibroids with MR guided focused ultrasound following 3 months pre-treatment with Gonadotrophin releasing analogues will allow the effective use of this therapy in women with larger fibroids. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- Magnetic Resonance Guided Focused Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2003to Dec 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has given consent
- Willing and able to attend all visits
- Minimum age 18 with no desire for future fertility
- Uterine fibroid > 300 cc on MRI
- Normal cervical smear
- Screening symptom score >21
- Pre or peri-menopausal
- Fibroids being device accessible
Who cannot join
- Pregnancy
- Previous GNRH treatment
- HRT use
- Hormonal Contraception
- Patient on dialysis
- Haematocrit <25
Show all 18Show fewer
- ASA score > 2
- Severe cerebrovascular disease
- Anticoagulated
- Active pelvic infection or history of PID
- Weight> 250 lbs
- Any contra-indication to MR imaging
- Intolerance to MRI contrast agent
- Unable to remain in prone positions for 3hours
- IUCD
- Abdominal scarring in beam pathway
- Breast feeding
- Non-perfused fibroid on contrast enhanced images
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Interventional Magnetic Resonance, St Mary's Hospital
London, W2 1NY
About this study
Official title: Phase 4 Study of Magnetic Resonance Guided Focused Ultrasound Surgery Following Gonadotrophin Releasing Hormone Agonist Treatment for Symptomatic Uterine Fibroids
The purpose of this study is to determine whether ablation of uterine fibroids with MR guided focused ultrasound following 3 months pre-treatment with Gonadotrophin releasing analogues will allow the effective use of this therapy in women with larger fibroids.
- Conditions
- Uterine Fibroids
- Being tested
- Magnetic Resonance Guided Focused Ultrasound
- Keywords
- Magnetic Resonance Guided Focused Ultrasound, Gonadotrophin Releasing Hormone Agonist, Uterine Fibroids
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Guided Focused UltrasoundProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom improvement as judged by validated disease specific questionnaire
Secondary outcomes (1)
Change in fibroid and uterine volume.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2003
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- InSightec-TxSonics
- Investigators
- wady m gedroyc, Principal investigator, St Mary's Hospital, Imperial College London.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159328
- Sponsor's protocol ID
- UF008
- Status last verified
- Aug 2008
- First submitted
- 9 Sep 2005
- Last updated
- 13 Aug 2008
- Results posted
- No
Publications
Hindley J, Gedroyc WM, Regan L, Stewart E, Tempany C, Hynyen K, Mcdannold N, Inbar Y, Itzchak Y, Rabinovici J, Kim HS, Geschwind JF, Hesley G, Gostout B, Ehrenstein T, Hengst S, Sklair-Levy M, Shushan A, Jolesz F. MRI guidance of focused ultrasound therapy of uterine fibroids: early results. AJR Am J Roentgenol. 2004 Dec;183(6):1713-9. doi: 10.2214/ajr.183.6.01831713.
PubMed 15547216Stewart EA, Gedroyc WM, Tempany CM, Quade BJ, Inbar Y, Ehrenstein T, Shushan A, Hindley JT, Goldin RD, David M, Sklair M, Rabinovici J. Focused ultrasound treatment of uterine fibroid tumors: safety and feasibility of a noninvasive thermoablative technique. Am J Obstet Gynecol. 2003 Jul;189(1):48-54. doi: 10.1067/mob.2003.345.
PubMed 12861137Tempany CM, Stewart EA, McDannold N, Quade BJ, Jolesz FA, Hynynen K. MR imaging-guided focused ultrasound surgery of uterine leiomyomas: a feasibility study. Radiology. 2003 Mar;226(3):897-905. doi: 10.1148/radiol.2271020395.
PubMed 12616023
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Magnetic Resonance Guided Focused Ultrasound Surgery Following Gonadotrophin Releasing Hormone Agonist Treatment for Symptomatic Uterine Fibroids
- ClinicalTrials.gov ID
- NCT00159328
- Acronym / sponsor ID
- UF008
- Conditions
- Uterine Fibroids
- Keywords
- Magnetic Resonance Guided Focused Ultrasound, Gonadotrophin Releasing Hormone Agonist, Uterine Fibroids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- InSightec-TxSonics
- Study start
- Mar 2003
- Study completion
- Dec 2006
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether ablation of uterine fibroids with MR guided focused ultrasound following 3 months pre-treatment with Gonadotrophin releasing analogues will allow the effective use of this therapy in women with larger fibroids.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject has given consent
- Willing and able to attend all visits
- Minimum age 18 with no desire for future fertility
- Uterine fibroid > 300 cc on MRI
- Normal cervical smear
Key exclusion criteria (18 listed)
- Pregnancy
- Previous GNRH treatment
- HRT use
- Hormonal Contraception
- Patient on dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Guided Focused Ultrasound | Procedure or surgery | – |
Primary outcome
Symptom improvement as judged by validated disease specific questionnaire
1 secondary outcome
Change in fibroid and uterine volume.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2008.
- Background: PubMed 15547216Hindley J, Gedroyc WM, Regan L, Stewart E, Tempany C, Hynyen K, Mcdannold N, Inbar Y, Itzchak Y, Rabinovici J, Kim HS, Geschwind JF, Hesley G, Gostout B, Ehrenstein T, Hengst S, Sklair-Levy M, Shushan A, Jolesz F. MRI guidance of focused ultrasound therapy of uterine fibroids: early results. AJR Am J Roentgenol. 2004 Dec;183(6):1713-9. doi: 10.2214/ajr.183.6.01831713.
- Background: PubMed 12861137Stewart EA, Gedroyc WM, Tempany CM, Quade BJ, Inbar Y, Ehrenstein T, Shushan A, Hindley JT, Goldin RD, David M, Sklair M, Rabinovici J. Focused ultrasound treatment of uterine fibroid tumors: safety and feasibility of a noninvasive thermoablative technique. Am J Obstet Gynecol. 2003 Jul;189(1):48-54. doi: 10.1067/mob.2003.345.
- Background: PubMed 12616023Tempany CM, Stewart EA, McDannold N, Quade BJ, Jolesz FA, Hynynen K. MR imaging-guided focused ultrasound surgery of uterine leiomyomas: a feasibility study. Radiology. 2003 Mar;226(3):897-905. doi: 10.1148/radiol.2271020395.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wady m gedroyc principal investigator
St Mary's Hospital, Imperial College London.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnetic Resonance Guided Focused Ultrasound in people with Uterine Fibroids, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom improvement as judged by validated disease specific questionnaire. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00159328, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2008.