Cervical CancerHIFU-GynaeNCT02714621
MR-HIFU for Recurrent Gynaecological Cancer
A study testing Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU) in people with Cervical Cancer and Endometrial Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial summary
The primary objective of this pilot study is to determine whether or not it is feasible to use MRgHIFU to treat symptomatic (pain, bleeding) recurrent pelvic malignancy with an acceptable safety profile when conventional treatment options are not available. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer, Uterine Cancer
- What is being tested?
- Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to 31 Mar 2020
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with recurrent pelvic gynaecological malignancy (cervix and endometrial cancer).
- Recurrent lesion is painful (NRS>4) and not suitable for alternative treatments
- Intended target volume accessible for MRgHIFU treatment
- Intended target volume visible on noncontrast MR imaging
- Distance between target and skin ≥1cm
Who cannot join
- MRI contraindicated (e.g. by incompatible metal implants or claustrophobia)
- Pregnancy
- Sedation contraindicated
- MRI contrast agent contraindicated
- Scar, internal or external fixation device along the beam path or at the target
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
Official title: Magnetic Resonance Guided High Intensity Focused Ultrasound (MRgHIFU): A Feasibility Study for Treating Recurrent Gynaecological Malignancies
The primary objective of this pilot study is to determine whether or not it is feasible to use MRgHIFU to treat symptomatic (pain, bleeding) recurrent pelvic malignancy with an acceptable safety profile when conventional treatment options are not available. The ultimate goal is to be able not only to offer a viable method of symptom palliation in patients with recurrent pelvic tumours and improve their quality of life; but also to control tumour growth and extend life in a group of relatively young patients with isolated local recurrence.
- Conditions
- Cervical Cancer, Endometrial Cancer, Uterine Cancer, Ovarian Cancer, Vaginal Cancer, Vulvar Cancer
- Being tested
- Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)
- Keywords
- Magnetic Resonance Imaging (MRI), High Intensity Focused Ultrasound (HIFU), Focused Ultrasound Surgery
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Uterine Neoplasms, Ovarian Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)Device
| Study group | Role | What they receive |
|---|---|---|
| Feasibility of MR-HIFU for painful gynaecological metastases | No intervention | Investigating whether it would be possible to use the MRgHIFU system to treat recurrent gynaecological cancers. |
| Treatment using MR-HIFU of painful gynaecological metastases | Experimental | Testing whether MRgHIFU could be an effective treatment for the symptoms of recurrent gynaecological cancers (pain and bleeding) Receives: Device: Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain, measured using a patient diary
Measured: 7 days post-treatment, follow up at 90 days
Secondary outcomes (1)
Changes in bleeding, measured using a questionnaire
Measured: 7 days post-treatment, follow up at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startMay 2016
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nandita deSouza, Institute of Cancer Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714621
- Sponsor's protocol ID
- 15/WM/0470 CCR4360
- Acronym
- HIFU-Gynae
- Status last verified
- Jul 2020
- First submitted
- 9 Mar 2016
- Last updated
- 15 Jul 2020
- Results posted
- No
Publications
Imseeh G, Giles SL, Taylor A, Brown MRD, Rivens I, Gordon-Williams R, Ter Haar G, deSouza NM. Feasibility of palliating recurrent gynecological tumors with MRGHIFU: comparison of symptom, quality-of-life, and imaging response in intra and extra-pelvic disease. Int J Hyperthermia. 2021;38(1):623-632. doi: 10.1080/02656736.2021.1904154.
PubMed 33882792
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Guided High Intensity Focused Ultrasound (MRgHIFU): A Feasibility Study for Treating Recurrent Gynaecological Malignancies
- ClinicalTrials.gov ID
- NCT02714621
- Acronym / sponsor ID
- HIFU-Gynae / 15/WM/0470 CCR4360
- Conditions
- Cervical Cancer, Endometrial Cancer, Uterine Cancer, Ovarian Cancer, Vaginal Cancer, Vulvar Cancer
- Keywords
- Magnetic Resonance Imaging (MRI), High Intensity Focused Ultrasound (HIFU), Focused Ultrasound Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 21 Mar 2016 (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 primary objective of this pilot study is to determine whether or not it is feasible to use MRgHIFU to treat symptomatic (pain, bleeding) recurrent pelvic malignancy with an acceptable safety profile when conventional treatment options are not available. The ultimate goal is to be able not only to offer a viable method of symptom palliation in patients with recurrent pelvic tumours and improve their quality of life; but also to control tumour growth and extend life in a group of relatively young patients with isolated local recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feasibility of MR-HIFU for painful gynaecological metastases | No intervention | –Investigating whether it would be possible to use the MRgHIFU system to treat recurrent gynaecological cancers. |
| Treatment using MR-HIFU of painful gynaecological metastases | Experimental | Device: Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)Testing whether MRgHIFU could be an effective treatment for the symptoms of recurrent gynaecological cancers (pain and bleeding) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with recurrent pelvic gynaecological malignancy (cervix and endometrial cancer).
- Recurrent lesion is painful (NRS>4) and not suitable for alternative treatments
- Intended target volume accessible for MRgHIFU treatment
- Intended target volume visible on noncontrast MR imaging
- Distance between target and skin ≥1cm
Key exclusion criteria (5 listed)
- MRI contraindicated (e.g. by incompatible metal implants or claustrophobia)
- Pregnancy
- Sedation contraindicated
- MRI contrast agent contraindicated
- Scar, internal or external fixation device along the beam path or at the target
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 Image-guided High Intensity Focused Ultrasound (MR-HIFU) | Device | Treatment using MR-HIFU of painful gynaecological metastases |
Primary outcome
Changes in pain, measured using a patient diary
Time frame: 7 days post-treatment, follow up at 90 days
1 secondary outcome
Changes in bleeding, measured using a questionnaire
Time frame: 7 days post-treatment, follow up at 90 days
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 15 Jul 2020.
- Derived from this study: PubMed 33882792Imseeh G, Giles SL, Taylor A, Brown MRD, Rivens I, Gordon-Williams R, Ter Haar G, deSouza NM. Feasibility of palliating recurrent gynecological tumors with MRGHIFU: comparison of symptom, quality-of-life, and imaging response in intra and extra-pelvic disease. Int J Hyperthermia. 2021;38(1):623-632. doi: 10.1080/02656736.2021.1904154.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU) in people with Cervical Cancer and Endometrial Cancer, run by Institute of Cancer Research, United Kingdom 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 5 inclusion and 5 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 15 Jul 2020. 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.
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?
Changes in pain, measured using a patient diary (time frame: 7 days post-treatment, follow up at 90 days). 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 NCT02714621, which also lists 1 linked publication.
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 15 Jul 2020.