Shoulder PainNCT01416740
A Comparison of Indirect and Direct MR Arthrography of the Shoulder Using Arthroscopic Correlation
A study testing Indirect MRA of shoulder and Gadopentetate Dimeglumine in people with Shoulder Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
This study will prospectively compare the findings of two diagnostic tests, Direct Magnetic Resonance Arthrography(MRA) and Indirect MRA, to the findings during shoulder arthroscopy in patients with shoulder pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Indirect MRA of shoulder and Gadopentetate Dimeglumine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Sep 2012
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 - 70 years old
- Continued shoulder pain for 2 months duration that limits his/her activity despite conservative treatment
- Had a standard of care Direct MR arthrogram performed from which the surgeon determined that arthroscopic surgery was indicated.
Who cannot join
- Clinical Evidence of
- Tumor
- Infection
- Previous shoulder surgery
- Contraindication for MRI
- Allergy to contrast
Show all 10Show fewer
- Coagulopathy
- Known allergy to gadolinium DTPA
- Renal failure with creatinine clearance of less than 30ml/min
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Bone and Joint Institute, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: A Prospective Comparison of Indirect and Direct MR Arthrography of the Shoulder Using Arthroscopic Correlation
This study will prospectively compare the findings of two diagnostic tests, Direct Magnetic Resonance Arthrography(MRA) and Indirect MRA, to the findings during shoulder arthroscopy in patients with shoulder pain. The sensitivity and specificity of both Direct and Indirect MRA's in diagnosing specific pathologies of the shoulder will be determined using shoulder arthroscopy as the gold standard.
Read the detailed description
Direct MR arthrography (MRA) requires the injection of a contrast agent into the shoulder under fluoroscopic or ultrasound guidance, followed by magnetic resonance imaging (MRI). This is invasive, risks infection, and requires time and resources. It has recently been shown that the intravenous administration of gadopentetate dimeglumine enhances the joint cavity during an MRI and thus indirectly produces an arthrographic effect(Indirect MRA). The study will enroll patients who have already had a Direct MRA as part of their standard of care diagnostic test for shoulder pain, if it is determined by their surgeon that arthroscopic surgery is indicated they will be asked if they would be willing to have an Indirect MRA prior to their arthroscopic surgery. The patient will need to have a blood test(BUN and Creatinine)done to ensure kidney function is normal, and a serum and urine pregnancy test, if female, to ensure there is no pregnancy, prior to the completion of the Indirect MRA. After the patient's scheduled shoulder arthroscopic surgery, the results of the two MR arthrography techniques will be compared for sensitivity and specificity in detecting partial and full thickness rotator cuff tears, labral tears, long head biceps dislocation/tearing, and grade IV cartilage lesions by comparing the results to the actual arthroscopic findings. The Direct MR arthrography and arthroscopic surgery are standard of care and would occur regardless of this study, the Indirect MR arthrography is the diagnostic intervention that is study-related.
- Conditions
- Shoulder Pain
- Being tested
- Indirect MRA of shoulder, Gadopentetate Dimeglumine
- Keywords
- Indirect magnetic resonance arthrogram, Direct magnetic resonance arthrogram, Diagnostic tests for shoulder pain
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect MRA of shoulderProcedure or surgery
Patient will be weighed and the correct dose of 0.1 mmol/kg calculated. An IV will be inserted into patient's arm. The gadopentetate dimeglumine will be injected into the IV and the patient is asked to gently exercise the shoulder (small windmills and flexion/extension) for 5 minutes. The patients then undergo MRI imaging 15-30 minutes after the injection. Contraindications include known allergy to gadopentetate dimeglumine, and renal failure with creatinine clearance of less than 30ml/min.
Gadopentetate DimeglumineDrug
Also called gadolinium DTPA, Magnevist
Patient will be weighed and the correct dose of 0.1 mmol/kg calculated. An IV will be inserted into patient's arm. The gadopentetate dimeglumine will be injected into the IV and the patient is asked to gently exercise the shoulder (small windmills and flexion/extension) for 5 minutes. The patients then undergo MRI imaging 15-30 minutes after the injection. Contraindications include known allergy to gadopentetate dimeglumine, and renal failure with creatinine clearance of less than 30ml/min.
| Study group | Role | What they receive |
|---|---|---|
| Indirect MRA | Experimental | After patient has signed consent and had blood tests to ensure normal kidney function (BUN and Creatinine) as well as serum and urine pregnancy tests for females to ensure there is no pregnancy, the patient will have an Indirect MRA. The participant will be weighed and the correct dose of 0.1 mmol/kg calculated. An IV will be inserted into participant's arm. The gadopentetate dimeglumine will be injected into the IV and the patient will be asked to gently exercise the shoulder (small windmills and flexion/extension) for 5 minutes. The patients then undergo MRI imaging 15-30 minutes after the injection. Contraindications include known allergy to gadopentetate dimeglumine, and renal failure with creatinine clearance of less than 30ml/min. Receives: Procedure: Indirect MRA of shoulder; Drug: Gadopentetate Dimeglumine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of Direct and Indirect MR Arthrograms in detecting pathologies of the shoulder when compared with Arthroscopic findings.
This study will compare the findings of the Indirect MRA and the retrospective data of the Direct MRA, to the results obtained during their arthroscopic shoulder surgery in patients with shoulder pain. The incidence of partial and full thickness rotator cuff tears, long head biceps dislocation/tearing, and grade IV cartilage lesions will be recorded for each type of MRA of the shoulder. The sensitivity and specificity of both direct and indirect MR arthrography in diagnosing shoulder problems will be determined by what was actually visualized during their arthroscopic shoulder surgery.
Measured: Patients will be foollowed from their Indirect MRA to their arthoscopic shoulder surgery, approximately one month from time of consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startDec 2009
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: difficulty with recruitment, PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Robert Lyons, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416740
- Sponsor's protocol ID
- 31905
- Status last verified
- Aug 2011
- First submitted
- 11 Aug 2011
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Jung JY, Yoon YC, Yi SK, Yoo J, Choe BK. Comparison study of indirect MR arthrography and direct MR arthrography of the shoulder. Skeletal Radiol. 2009 Jul;38(7):659-67. doi: 10.1007/s00256-009-0660-7. Epub 2009 Feb 19.
PubMed 19225775Oh DK, Yoon YC, Kwon JW, Choi SH, Jung JY, Bae S, Yoo J. Comparison of indirect isotropic MR arthrography and conventional MR arthrography of labral lesions and rotator cuff tears: a prospective study. AJR Am J Roentgenol. 2009 Feb;192(2):473-9. doi: 10.2214/AJR.08.1223.
PubMed 19155413Herold T, Bachthaler M, Hamer OW, Hente R, Feuerbach S, Fellner C, Strotzer M, Lenhart M, Paetzel C. Indirect MR arthrography of the shoulder: use of abduction and external rotation to detect full- and partial-thickness tears of the supraspinatus tendon. Radiology. 2006 Jul;240(1):152-60. doi: 10.1148/radiol.2393050453. Epub 2006 May 18.
PubMed 16709790Dinauer PA, Flemming DJ, Murphy KP, Doukas WC. Diagnosis of superior labral lesions: comparison of noncontrast MRI with indirect MR arthrography in unexercised shoulders. Skeletal Radiol. 2007 Mar;36(3):195-202. doi: 10.1007/s00256-006-0237-7. Epub 2006 Dec 1.
PubMed 17139503
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of Indirect and Direct MR Arthrography of the Shoulder Using Arthroscopic Correlation
- ClinicalTrials.gov ID
- NCT01416740
- Acronym / sponsor ID
- 31905
- Conditions
- Shoulder Pain
- Keywords
- Indirect magnetic resonance arthrogram, Direct magnetic resonance arthrogram, Diagnostic tests for shoulder pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: difficulty with recruitment, PI left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 15 Aug 2011 (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.
This study will prospectively compare the findings of two diagnostic tests, Direct Magnetic Resonance Arthrography(MRA) and Indirect MRA, to the findings during shoulder arthroscopy in patients with shoulder pain. The sensitivity and specificity of both Direct and Indirect MRA's in diagnosing specific pathologies of the shoulder will be determined using shoulder arthroscopy as the gold standard.
Detailed description
Direct MR arthrography (MRA) requires the injection of a contrast agent into the shoulder under fluoroscopic or ultrasound guidance, followed by magnetic resonance imaging (MRI). This is invasive, risks infection, and requires time and resources. It has recently been shown that the intravenous administration of gadopentetate dimeglumine enhances the joint cavity during an MRI and thus indirectly produces an arthrographic effect(Indirect MRA). The study will enroll patients who have already had a Direct MRA as part of their standard of care diagnostic test for shoulder pain, if it is determined by their surgeon that arthroscopic surgery is indicated they will be asked if they would be willing to have an Indirect MRA prior to their arthroscopic surgery. The patient will need to have a blood test(BUN and Creatinine)done to ensure kidney function is normal, and a serum and urine pregnancy test, if female, to ensure there is no pregnancy, prior to the completion of the Indirect MRA. After the patient's scheduled shoulder arthroscopic surgery, the results of the two MR arthrography techniques will be compared for sensitivity and specificity in detecting partial and full thickness rotator cuff tears, labral tears, long head biceps dislocation/tearing, and grade IV cartilage lesions by comparing the results to the actual arthroscopic findings. The Direct MR arthrography and arthroscopic surgery are standard of care and would occur regardless of this study, the Indirect MR arthrography is the diagnostic intervention that is study-related.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indirect MRA | Experimental | Procedure: Indirect MRA of shoulder, Drug: Gadopentetate DimeglumineAfter patient has signed consent and had blood tests to ensure normal kidney function (BUN and Creatinine) as well as serum and urine pregnancy tests for females to ensure there is no pregnancy, the patient will have an Indirect MRA. The participant will be weighed and the correct dose of 0.1 mmol/kg calculated. An IV will be inserted into participant's arm. The gadopentetate dimeglumine will be injected into the IV and the patient will be asked to gently exercise the shoulder (small windmills and flexion/extension) for 5 minutes. The patients then undergo MRI imaging 15-30 minutes after the injection. Contraindications include known allergy to gadopentetate dimeglumine, and renal failure with creatinine clearance of less than 30ml/min. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between 18 - 70 years old
- Continued shoulder pain for 2 months duration that limits his/her activity despite conservative treatment
- Had a standard of care Direct MR arthrogram performed from which the surgeon determined that arthroscopic surgery was indicated.
Key exclusion criteria (10 listed)
- Clinical Evidence of
- Tumor
- Infection
- Previous shoulder surgery
- Contraindication for MRI
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 |
|---|---|---|
| Indirect MRA of shoulderPatient will be weighed and the correct dose of 0.1 mmol/kg calculated. An IV will be inserted into patient's arm. The gadopentetate dimeglumine will be injected into the IV and the patient is asked to gently exercise the shoulder (small windmills and flexion/extension) for 5 minutes. The patients then undergo MRI imaging 15-30 minutes after the injection. Contraindications include known allergy to gadopentetate dimeglumine, and renal failure with creatinine clearance of less than 30ml/min. | Procedure or surgery | Indirect MRA |
| Gadopentetate DimeglumineAlso: gadolinium DTPA, MagnevistPatient will be weighed and the correct dose of 0.1 mmol/kg calculated. An IV will be inserted into patient's arm. The gadopentetate dimeglumine will be injected into the IV and the patient is asked to gently exercise the shoulder (small windmills and flexion/extension) for 5 minutes. The patients then undergo MRI imaging 15-30 minutes after the injection. Contraindications include known allergy to gadopentetate dimeglumine, and renal failure with creatinine clearance of less than 30ml/min. | Drug | Indirect MRA |
Primary outcome
Sensitivity and specificity of Direct and Indirect MR Arthrograms in detecting pathologies of the shoulder when compared with Arthroscopic findings.
Time frame: Patients will be foollowed from their Indirect MRA to their arthoscopic shoulder surgery, approximately one month from time of consent
This study will compare the findings of the Indirect MRA and the retrospective data of the Direct MRA, to the results obtained during their arthroscopic shoulder surgery in patients with shoulder pain. The incidence of partial and full thickness rotator cuff tears, long head biceps dislocation/tearing, and grade IV cartilage lesions will be recorded for each type of MRA of the shoulder. The sensitivity and specificity of both direct and indirect MR arthrography in diagnosing shoulder problems will be determined by what was actually visualized during their arthroscopic shoulder surgery.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
- Background: PubMed 19225775Jung JY, Yoon YC, Yi SK, Yoo J, Choe BK. Comparison study of indirect MR arthrography and direct MR arthrography of the shoulder. Skeletal Radiol. 2009 Jul;38(7):659-67. doi: 10.1007/s00256-009-0660-7. Epub 2009 Feb 19.
- Background: PubMed 19155413Oh DK, Yoon YC, Kwon JW, Choi SH, Jung JY, Bae S, Yoo J. Comparison of indirect isotropic MR arthrography and conventional MR arthrography of labral lesions and rotator cuff tears: a prospective study. AJR Am J Roentgenol. 2009 Feb;192(2):473-9. doi: 10.2214/AJR.08.1223.
- Background: PubMed 16709790Herold T, Bachthaler M, Hamer OW, Hente R, Feuerbach S, Fellner C, Strotzer M, Lenhart M, Paetzel C. Indirect MR arthrography of the shoulder: use of abduction and external rotation to detect full- and partial-thickness tears of the supraspinatus tendon. Radiology. 2006 Jul;240(1):152-60. doi: 10.1148/radiol.2393050453. Epub 2006 May 18.
- Background: PubMed 17139503Dinauer PA, Flemming DJ, Murphy KP, Doukas WC. Diagnosis of superior labral lesions: comparison of noncontrast MRI with indirect MR arthrography in unexercised shoulders. Skeletal Radiol. 2007 Mar;36(3):195-202. doi: 10.1007/s00256-006-0237-7. Epub 2006 Dec 1.
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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.
Robert Lyons, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indirect MRA of shoulder and Gadopentetate Dimeglumine in people with Shoulder Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
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 3 inclusion and 10 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: withdrawn, as of the sponsor's last update on 26 Mar 2014. 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 States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Sensitivity and specificity of Direct and Indirect MR Arthrograms in detecting pathologies of the shoulder when compared with Arthroscopic findings. (time frame: Patients will be foollowed from their Indirect MRA to their arthoscopic shoulder surgery, approximately one month from time of consent). 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 NCT01416740, which also lists 4 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 26 Mar 2014.