Magnetic Resonance Imaging or Ultrasound in Soft Tissue Tumors (MUSTT) (MUSTT)

July 13, 2016 updated by: Alberto Tagliafico, University of Genova

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genova, Italy, 16132
        • Recruiting
        • Unige

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients operated on for localized soft tissue sarcomas of the limb

Description

Inclusion Criteria:

  • Patients operated on for localized soft tissue sarcomas of the limb

Exclusion Criteria:

  • Unable to understand or execute written informed consent
  • Unable or unwilling to agree to follow-up during observation period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Ultrasound
Patients undergoing Ultrasound
Other: Ultrasound
Magnetic Resonance Imaging
Patients undergoing Magnetic Resonance Imaging
Other: Ultrasound

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Sensitivity of US in the detection of local recurrences
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Genova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 223REG2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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