SarcomaMUSTTNCT02834585
Magnetic Resonance Imaging or Ultrasound in Soft Tissue Tumors (MUSTT)
An observational study of Sarcoma and Soft Tissue Tumors, run by University of Genova at 1 site in Italy.
Trial summary
Adult soft tissue sarcomas (STS) are rare tumours with an estimated incidence averaging 5/100 000/year in Europe. The prognosis of soft tissue sarcomas is dominated by local recurrence and distant metastasis. A link seems to exist between local recurrence and overall survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Soft Tissue Tumors, Ultrasound
- What is being tested?
- Ultrasound
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2014to Dec 2020
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients operated on for localized soft tissue sarcomas of the limb
Who may be able to join
- Patients operated on for localized soft tissue sarcomas of the limb
Who cannot join
- Unable to understand or execute written informed consent
- Unable or unwilling to agree to follow-up during observation period
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
UNIGE
Genova, Genova, 16132
Alberto S Tagliafico, MD, +390103637873, alberto.tagliafico@unige.it
Alberto S Tagliafico, MD
About this study
Official title: Follow-up of Recurrences of Limb Soft Tissue Sarcomas in Patients With Localized Disease: Performance of Ultrasound
Adult soft tissue sarcomas (STS) are rare tumours with an estimated incidence averaging 5/100 000/year in Europe. The prognosis of soft tissue sarcomas is dominated by local recurrence and distant metastasis. A link seems to exist between local recurrence and overall survival. Local recurrence occurs in approximately 16-29% of STS of the limbs. A combination of resection and radiotherapy is the optimal treatment of primary tumours according to histological grade and surgical result. Modern imaging techniques such as ultrasound (US), magnetic resonance (MR) and computed tomography (CT) are normally used to rule-out a recurrence in patients operated on for STS. However, none of this technique is perfect and different advantages and drawbacks have to be considered in choosing one or another technique. In the past, US was used in tumour follow-up to detect tumour recurrences, however these studies didn't use high-resolution transducers and the timing of imaging respect to surgery was not defined. The recent advances in transducer technology improved the diagnostic capabilities of US.
For the evaluation of limbs soft-tissue masses, US is widely used as a first level modality. The reasons are that US is widely available, fast, easily repeatable and often more accessible than CT and MR Imaging. In addition, US equipped with high-frequency transducers have a spatial resolution that may be comparable or higher than that of MR Imaging and CT in the evaluation of superficial soft-tissues. US and MR Imaging are often not able to differentiate benign from malignant tumours, therefore several lesions detected with US or MR Imaging warrant biopsy. The clinical practice guidelines of the ESMO (European Society of Medical Oncology) published in 2010 found that there are no published data to indicate the optimal routine follow-up policy of surgically treated patients with localized disease. Moreover, it has not been demonstrated that, for limb sarcomas recurrences, MR Imaging is superior and cost-effective compared to US for the assessment of the primary site. Considering that surgically treated intermediate-/high-grade patient may be followed frequently, even every 3-4 months in the first 2-3 years and considering that performing US is easier than having MR Imaging, the purpose of this study is to evaluate the diagnostic performance of US in the detection of local recurrences of adults patients with soft tissue sarcomas of the limb.
Read the detailed description
Adult soft tissue sarcomas (STS) are rare tumours with an estimated incidence averaging 5/100 000/year in Europe. The prognosis of soft tissue sarcomas is dominated by local recurrence and distant metastasis. A link seems to exist between local recurrence and overall survival. Local recurrence occurs in approximately 16-29% of STS of the limbs. A combination of resection and radiotherapy is the optimal treatment of primary tumours according to histological grade and surgical result. Modern imaging techniques such as ultrasound (US), magnetic resonance (MR) and computed tomography (CT) are normally used to rule-out a recurrence in patients operated on for STS. However, none of this technique is perfect and different advantages and drawbacks have to be considered in choosing one or another technique. In the past, US was used in tumour follow-up to detect tumour recurrences, however these studies didn't use high-resolution transducers and the timing of imaging respect to surgery was not defined. The recent advances in transducer technology improved the diagnostic capabilities of US.
For the evaluation of limbs soft-tissue masses, US is widely used as a first level modality. The reasons are that US is widely available, fast, easily repeatable and often more accessible than CT and MR Imaging. In addition, US equipped with high-frequency transducers have a spatial resolution that may be comparable or higher than that of MR Imaging and CT in the evaluation of superficial soft-tissues. US and MR Imaging are often not able to differentiate benign from malignant tumours, therefore several lesions detected with US or MR Imaging warrant biopsy. The clinical practice guidelines of the ESMO (European Society of Medical Oncology) published in 2010 found that there are no published data to indicate the optimal routine follow-up policy of surgically treated patients with localized disease. Moreover, it has not been demonstrated that, for limb sarcomas recurrences, MR Imaging is superior and cost-effective compared to US for the assessment of the primary site. Considering that surgically treated intermediate-/high-grade patient may be followed frequently, even every 3-4 months in the first 2-3 years and considering that performing US is easier than having MR Imaging, the purpose of this study is to evaluate the diagnostic performance of US in the detection of local recurrences of adults patients with soft tissue sarcomas of the limb.
The clinical practice guidelines of the ESMO (European Society of Medical Oncology) published in 2010 found that there are no published data to indicate the optimal routine follow-up policy of surgically treated patients with localized disease. Moreover, it has not been demonstrated that, for limb sarcomas recurrences, MR Imaging is superior and cost-effective compared to US for the assessment of the primary site. Considering that surgically treated intermediate-/high-grade patient may be followed frequently, even every 3-4 months in the first 2-3 years, if US is demonstrated to be non-inferior to MRI a great sparing of healthcare resources will be warranted. In addition, patients operated on for localized soft tissue sarcomas of the limb will be possibly followed-up with clinical examination and US instead of MR Imaging.
- Conditions
- Sarcoma, Soft Tissue Tumors, Ultrasound, Magnetic Resonance Imaging, Diagnostic Accuracy, Sensitivity
- Being tested
- Ultrasound
- Medical subject headings
- Sarcoma, Soft Tissue Neoplasms, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundOther
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Patients undergoing Ultrasound Receives: Other: Ultrasound | |
| Magnetic Resonance Imaging | Patients undergoing Magnetic Resonance Imaging Receives: Other: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of US in the detection of local recurrences
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startOct 2014
- Primary completionJan 2020 (estimated)
- Study completionDec 2020 (estimated)
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 SarcomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Tagliafico, University of Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834585
- Sponsor's protocol ID
- 223REG2014
- Acronym
- MUSTT
- Status last verified
- Jul 2016
- First submitted
- 13 Jul 2016
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tagliafico A, Truini M, Spina B, Cambiaso P, Zaottini F, Bignotti B, Calabrese M, Derchi LE, Martinoli C. Follow-up of recurrences of limb soft tissue sarcomas in patients with localized disease: performance of ultrasound. Eur Radiol. 2015 Sep;25(9):2764-70. doi: 10.1007/s00330-015-3645-z. Epub 2015 Mar 21.
PubMed 25794664
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Recurrences of Limb Soft Tissue Sarcomas in Patients With Localized Disease: Performance of Ultrasound
- ClinicalTrials.gov ID
- NCT02834585
- Acronym / sponsor ID
- MUSTT / 223REG2014
- Conditions
- Sarcoma, Soft Tissue Tumors, Ultrasound, Magnetic Resonance Imaging, Diagnostic Accuracy, Sensitivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 Jul 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.
Adult soft tissue sarcomas (STS) are rare tumours with an estimated incidence averaging 5/100 000/year in Europe. The prognosis of soft tissue sarcomas is dominated by local recurrence and distant metastasis. A link seems to exist between local recurrence and overall survival. Local recurrence occurs in approximately 16-29% of STS of the limbs. A combination of resection and radiotherapy is the optimal treatment of primary tumours according to histological grade and surgical result. Modern imaging techniques such as ultrasound (US), magnetic resonance (MR) and computed tomography (CT) are normally used to rule-out a recurrence in patients operated on for STS. However, none of this technique is perfect and different advantages and drawbacks have to be considered in choosing one or another technique. In the past, US was used in tumour follow-up to detect tumour recurrences, however these studies didn't use high-resolution transducers and the timing of imaging respect to surgery was not defined. The recent advances in transducer technology improved the diagnostic capabilities of US.
For the evaluation of limbs soft-tissue masses, US is widely used as a first level modality. The reasons are that US is widely available, fast, easily repeatable and often more accessible than CT and MR Imaging. In addition, US equipped with high-frequency transducers have a spatial resolution that may be comparable or higher than that of MR Imaging and CT in the evaluation of superficial soft-tissues. US and MR Imaging are often not able to differentiate benign from malignant tumours, therefore several lesions detected with US or MR Imaging warrant biopsy. The clinical practice guidelines of the ESMO (European Society of Medical Oncology) published in 2010 found that there are no published data to indicate the optimal routine follow-up policy of surgically treated patients with localized disease. Moreover, it has not been demonstrated that, for limb sarcomas recurrences, MR Imaging is superior and cost-effective compared to US for the assessment of the primary site. Considering that surgically treated intermediate-/high-grade patient may be followed frequently, even every 3-4 months in the first 2-3 years and considering that performing US is easier than having MR Imaging, the purpose of this study is to evaluate the diagnostic performance of US in the detection of local recurrences of adults patients with soft tissue sarcomas of the limb.
Detailed description
Adult soft tissue sarcomas (STS) are rare tumours with an estimated incidence averaging 5/100 000/year in Europe. The prognosis of soft tissue sarcomas is dominated by local recurrence and distant metastasis. A link seems to exist between local recurrence and overall survival. Local recurrence occurs in approximately 16-29% of STS of the limbs. A combination of resection and radiotherapy is the optimal treatment of primary tumours according to histological grade and surgical result. Modern imaging techniques such as ultrasound (US), magnetic resonance (MR) and computed tomography (CT) are normally used to rule-out a recurrence in patients operated on for STS. However, none of this technique is perfect and different advantages and drawbacks have to be considered in choosing one or another technique. In the past, US was used in tumour follow-up to detect tumour recurrences, however these studies didn't use high-resolution transducers and the timing of imaging respect to surgery was not defined. The recent advances in transducer technology improved the diagnostic capabilities of US.
For the evaluation of limbs soft-tissue masses, US is widely used as a first level modality. The reasons are that US is widely available, fast, easily repeatable and often more accessible than CT and MR Imaging. In addition, US equipped with high-frequency transducers have a spatial resolution that may be comparable or higher than that of MR Imaging and CT in the evaluation of superficial soft-tissues. US and MR Imaging are often not able to differentiate benign from malignant tumours, therefore several lesions detected with US or MR Imaging warrant biopsy. The clinical practice guidelines of the ESMO (European Society of Medical Oncology) published in 2010 found that there are no published data to indicate the optimal routine follow-up policy of surgically treated patients with localized disease. Moreover, it has not been demonstrated that, for limb sarcomas recurrences, MR Imaging is superior and cost-effective compared to US for the assessment of the primary site. Considering that surgically treated intermediate-/high-grade patient may be followed frequently, even every 3-4 months in the first 2-3 years and considering that performing US is easier than having MR Imaging, the purpose of this study is to evaluate the diagnostic performance of US in the detection of local recurrences of adults patients with soft tissue sarcomas of the limb.
The clinical practice guidelines of the ESMO (European Society of Medical Oncology) published in 2010 found that there are no published data to indicate the optimal routine follow-up policy of surgically treated patients with localized disease. Moreover, it has not been demonstrated that, for limb sarcomas recurrences, MR Imaging is superior and cost-effective compared to US for the assessment of the primary site. Considering that surgically treated intermediate-/high-grade patient may be followed frequently, even every 3-4 months in the first 2-3 years, if US is demonstrated to be non-inferior to MRI a great sparing of healthcare resources will be warranted. In addition, patients operated on for localized soft tissue sarcomas of the limb will be possibly followed-up with clinical examination and US instead of MR Imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | – | Other: UltrasoundPatients undergoing Ultrasound |
| Magnetic Resonance Imaging | – | Other: UltrasoundPatients undergoing Magnetic Resonance Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated on for localized soft tissue sarcomas of the limb
Key inclusion criteria (1 listed)
- Patients operated on for localized soft tissue sarcomas of the limb
Key exclusion criteria (2 listed)
- Unable to understand or execute written informed consent
- Unable or unwilling to agree to follow-up during observation period
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 |
|---|---|---|
| Ultrasound | Other | Magnetic Resonance Imaging, Ultrasound |
Primary outcome
Sensitivity of US in the detection of local recurrences
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2016.
- Results publication: PubMed 25794664Tagliafico A, Truini M, Spina B, Cambiaso P, Zaottini F, Bignotti B, Calabrese M, Derchi LE, Martinoli C. Follow-up of recurrences of limb soft tissue sarcomas in patients with localized disease: performance of ultrasound. Eur Radiol. 2015 Sep;25(9):2764-70. doi: 10.1007/s00330-015-3645-z. Epub 2015 Mar 21.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma and Soft Tissue Tumors, run by University of Genova at 1 site in Italy.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Jul 2016. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of US in the detection of local recurrences (time frame: 4 years). 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 NCT02834585, 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 2016; AzTrials last refreshed its copy on 8 Nov 2026.