Knee Cyst Popliteal (___Cm)NCT03885986
Ultrasound Evaluation of Cystic Lesions in the Knee:In Comparison to Magnetic Resonance Imaging
An observational study of Knee Cyst Popliteal (___Cm), run by Assiut University.
Trial summary
Benign cysts and cystic-appearing lesions in and around the knee are common and differentiation between them through the history, symptoms and clinical examination is difficult due to the presence of common findings such as pain, edema, and palpable mass. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Cyst Popliteal (___Cm)
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2019to 10 Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: - Patients in different age groups referred to Radiology department at Assiut University Hospital with clinically suspected benign cystic lesions in and around the knee.
Who may be able to join
- 1. clinically diagnosed cystic lesions in and around the knee.
Who cannot join
- arthroscopy or surgical intervention to the knee joint.
- fracture repaired by metal plates or screws.
- claustrophobia.
- contraindications to MRI as patients with implanted pacemaker or defibrillator, ferromagnetic aneurysm clips and metallic foreign body at the knee joint.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ultrasound Evaluation of Cysts and "Cyst-like" Lesions in and Around the Knee:In Comparison to Magnetic Resonance Imaging
Benign cysts and cystic-appearing lesions in and around the knee are common and differentiation between them through the history, symptoms and clinical examination is difficult due to the presence of common findings such as pain, edema, and palpable mass. The clinical presentation depends on the location, size of the lesion and its relation with the surrounding structures.
Read the detailed description
The Benign knee cysts can be subdivided into four major categories as following:1- synovial cysts, 2- popliteal (Baker's) cyst, 3- ganglion cysts, 4- meniscal cysts. Whereas, The "cyst-like" lesions can be sub-classified into the following:1- normal knee bursae, 2- normal knee recesses, 3- miscellaneous cyst-like lesions as aneurysms, hematomas, seromas and abscess.
Many of these lesions have fairly characteristic locations and imaging features. Knowledge of these variants and lesions is essential for accurate diagnosis and to avoid mistaking them for aggressive soft tissue lesions, including sarcomas. Ultrasonography and magnetic resonance imaging are the most useful imaging modalities in evaluating these Benign cystic lesions. Ultrasonography can distinguish cysts from solid lesions and assess the degree of vascularity within the lesion. Magnetic resonance imaging can help to delineate the location of the lesion in relation to anatomic structures and also determine if the lesion is cystic or solid when contrast is administered.
- Conditions
- Knee Cyst Popliteal (___Cm)
- Being tested
- Ultrasound
- Medical subject headings
- Popliteal Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundRadiation
Also called magnetic resonance imaging
role of ultrasound in comparison to magnetic resonance imaging in diagnosis of benign cystic lesions of knee
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of ultrasound and magnetic resonance imaging in diagnosis of Benign knee cysts
Results of ultrasound in comparison to results of magnetic resonance imaging in diagnosis of Benign knee cysts.
Measured: within 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start10 Dec 2019 (estimated)
- Primary completion10 Jun 2021 (estimated)
- Study completion10 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Knee Cyst Popliteal (___Cm)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Bahaa Boshra, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885986
- Sponsor's protocol ID
- US,MRI of knee cysts
- Status last verified
- Jul 2019
- First submitted
- 18 Mar 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perdikakis E, Skiadas V. MRI characteristics of cysts and "cyst-like" lesions in and around the knee: what the radiologist needs to know. Insights Imaging. 2013 Jun;4(3):257-72. doi: 10.1007/s13244-013-0240-1. Epub 2013 Mar 12.
PubMed 23479129Telischak NA, Wu JS, Eisenberg RL. Cysts and cystic-appearing lesions of the knee: A pictorial essay. Indian J Radiol Imaging. 2014 Apr;24(2):182-91. doi: 10.4103/0971-3026.134413.
PubMed 25024531Wu JS, Hochman MG. Soft-tissue tumors and tumorlike lesions: a systematic imaging approach. Radiology. 2009 Nov;253(2):297-316. doi: 10.1148/radiol.2532081199.
PubMed 19864525Bermejo A, De Bustamante TD, Martinez A, Carrera R, Zabia E, Manjon P. MR imaging in the evaluation of cystic-appearing soft-tissue masses of the extremities. Radiographics. 2013 May;33(3):833-55. doi: 10.1148/rg.333115062.
PubMed 23674777Steinbach LS, Stevens KJ. Imaging of cysts and bursae about the knee. Radiol Clin North Am. 2013 May;51(3):433-54. doi: 10.1016/j.rcl.2012.10.005. Epub 2013 Jan 12.
PubMed 23622093Alessi S, Depaoli R, Canepari M, Bartolucci F, Zacchino M, Draghi F. Baker's cyst in pediatric patients: Ultrasonographic characteristics. J Ultrasound. 2012 Feb;15(1):76-81. doi: 10.1016/j.jus.2011.06.007. Epub 2011 Jul 1.
PubMed 23396996
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation of Cysts and "Cyst-like" Lesions in and Around the Knee:In Comparison to Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT03885986
- Acronym / sponsor ID
- US,MRI of knee cysts
- Conditions
- Knee Cyst Popliteal (___Cm)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Dec 2019 (estimated)
- Primary completion
- 10 Jun 2021 (estimated)
- Study completion
- 10 Dec 2021 (estimated)
- First posted
- 22 Mar 2019 (actual)
- 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.
Benign cysts and cystic-appearing lesions in and around the knee are common and differentiation between them through the history, symptoms and clinical examination is difficult due to the presence of common findings such as pain, edema, and palpable mass. The clinical presentation depends on the location, size of the lesion and its relation with the surrounding structures.
Detailed description
The Benign knee cysts can be subdivided into four major categories as following:1- synovial cysts, 2- popliteal (Baker's) cyst, 3- ganglion cysts, 4- meniscal cysts. Whereas, The "cyst-like" lesions can be sub-classified into the following:1- normal knee bursae, 2- normal knee recesses, 3- miscellaneous cyst-like lesions as aneurysms, hematomas, seromas and abscess.
Many of these lesions have fairly characteristic locations and imaging features. Knowledge of these variants and lesions is essential for accurate diagnosis and to avoid mistaking them for aggressive soft tissue lesions, including sarcomas. Ultrasonography and magnetic resonance imaging are the most useful imaging modalities in evaluating these Benign cystic lesions. Ultrasonography can distinguish cysts from solid lesions and assess the degree of vascularity within the lesion. Magnetic resonance imaging can help to delineate the location of the lesion in relation to anatomic structures and also determine if the lesion is cystic or solid when contrast is administered.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- - Patients in different age groups referred to Radiology department at Assiut University Hospital with clinically suspected benign cystic lesions in and around the knee.
Key inclusion criteria (1 listed)
- 1. clinically diagnosed cystic lesions in and around the knee.
Key exclusion criteria (4 listed)
- arthroscopy or surgical intervention to the knee joint.
- fracture repaired by metal plates or screws.
- claustrophobia.
- contraindications to MRI as patients with implanted pacemaker or defibrillator, ferromagnetic aneurysm clips and metallic foreign body at the knee joint.
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 |
|---|---|---|
| UltrasoundAlso: magnetic resonance imagingrole of ultrasound in comparison to magnetic resonance imaging in diagnosis of benign cystic lesions of knee | Radiation | – |
Primary outcome
Role of ultrasound and magnetic resonance imaging in diagnosis of Benign knee cysts
Time frame: within 3 hours
Results of ultrasound in comparison to results of magnetic resonance imaging in diagnosis of Benign knee cysts.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Background: PubMed 23479129Perdikakis E, Skiadas V. MRI characteristics of cysts and "cyst-like" lesions in and around the knee: what the radiologist needs to know. Insights Imaging. 2013 Jun;4(3):257-72. doi: 10.1007/s13244-013-0240-1. Epub 2013 Mar 12.
- Background: PubMed 25024531Telischak NA, Wu JS, Eisenberg RL. Cysts and cystic-appearing lesions of the knee: A pictorial essay. Indian J Radiol Imaging. 2014 Apr;24(2):182-91. doi: 10.4103/0971-3026.134413.
- Background: PubMed 19864525Wu JS, Hochman MG. Soft-tissue tumors and tumorlike lesions: a systematic imaging approach. Radiology. 2009 Nov;253(2):297-316. doi: 10.1148/radiol.2532081199.
- Background: PubMed 23674777Bermejo A, De Bustamante TD, Martinez A, Carrera R, Zabia E, Manjon P. MR imaging in the evaluation of cystic-appearing soft-tissue masses of the extremities. Radiographics. 2013 May;33(3):833-55. doi: 10.1148/rg.333115062.
- Background: PubMed 23622093Steinbach LS, Stevens KJ. Imaging of cysts and bursae about the knee. Radiol Clin North Am. 2013 May;51(3):433-54. doi: 10.1016/j.rcl.2012.10.005. Epub 2013 Jan 12.
- Background: PubMed 23396996Alessi S, Depaoli R, Canepari M, Bartolucci F, Zacchino M, Draghi F. Baker's cyst in pediatric patients: Ultrasonographic characteristics. J Ultrasound. 2012 Feb;15(1):76-81. doi: 10.1016/j.jus.2011.06.007. Epub 2011 Jul 1.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Cyst Popliteal (___Cm), run by Assiut University.
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 4 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 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Mostafa Thabet Hussein, Professor (0112-299-9878, thabet.mostafa@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of ultrasound and magnetic resonance imaging in diagnosis of Benign knee cysts (time frame: within 3 hours). 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 NCT03885986, which also lists 6 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 5 Jul 2019.