Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390475
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-18
Brief Title:
Optimizing Diagnosis of Splanchic Vein Thrombosis With MRDTI Rhea
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Optimizing Diagnosis of Splanchic Vein Thrombosis With MR Direct Thrombus Imaging the Rhea Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Rhea-study is a multicenter prospective diagnostic proof-of-concept study
There is an unquestionable need for improved diagnostic approaches for incidental SVT The researchers plan to evaluate the MRDTI technique that has been shown to be accurate in other settings of difficult-to-diagnosis venous thrombosis for the notoriously challenging diagnosis of incidental SVT This study targets an important unmet need and will provide the basis for precision medicine for patients with SVT in the near future ie the possibility of assessment of the age of the thrombus in patients with incidental SVT which is of utmost importance for determination of the indication for anticoagulant therapy
If this hypothesis is proven true ie sensitivity of MRDTI for SVT is indeed 90 the investigators will proceed with performing a randomized controlled outcome study in which patients with possibleprobable chronic SVT with normal MRDTI test results and no other indications for anticoagulant therapy These patients will be randomized between active therapeutically dosed anticoagulation versus no anticoagulation to compare clinical outcome with regard to the occurrence of venous thromboembolism andor Progressive symptomatic SVT as well as major bleeding
There is an unquestionable need for improved diagnostic approaches for incidental SVT The researchers plan to evaluate the MRDTI technique that has been shown to be accurate in other settings of difficult-to-diagnosis venous thrombosis for the notoriously challenging diagnosis of incidental SVT This study targets an important unmet need and will provide the basis for precision medicine for patients with SVT in the near future ie the possibility of assessment of the age of the thrombus in patients with incidental SVT which is of utmost importance for determination of the indication for anticoagulant therapy
If this hypothesis is proven true ie sensitivity of MRDTI for SVT is indeed 90 the investigators will proceed with performing a randomized controlled outcome study in which patients with possibleprobable chronic SVT with normal MRDTI test results and no other indications for anticoagulant therapy These patients will be randomized between active therapeutically dosed anticoagulation versus no anticoagulation to compare clinical outcome with regard to the occurrence of venous thromboembolism andor Progressive symptomatic SVT as well as major bleeding
Detailed Description:
Background
Splanchnic vein thrombosis SVT is one of the manifestations of unusual site venous thromboembolism VTE SVT includes portal vein thrombosis PVT mesenteric vein hrombosis MVT splenic vein thrombosis SpVT and the Budd-Chiairi syndrome BCSThere is no validated clinical algorithm for the diagnosis of SVT and there are no specific laboratory tests available to confirm or rule out the disease Particularly D-dimer tests do not have a role in the diagnosis of SVT due to its low specificity and the high percentage of false positive results especially in patients with cancer liver cirrhosis or underlying inflammatory conditions present in more than half of the total SVT population Thus the diagnosis of SVT relies on imaging tests alone Whereas Doppler ultrasound is the imaging test of choice for most forms of SVT its sensitivity is only 90 as is the sensitivity of CT angiography CTA MR angiography MRA has been reported to have 90-100 sensitivity for SVT but this technique is limited by the need to administer a contrast agent Furthermore in studies evaluating the accuracy of MRA for the diagnose of SVT gold standard for SVT surgical validation was lacking Importantly many of SVT diagnoses in clinical practice up to 30 are incidental findings ie findings on imaging tests of the abdomen performed for another reason than suspected SVT Whereas the diagnosis of symptomatic SVT is often challenging the correct diagnosis of acute versus chronic SVT is even more difficult as neither of the current available imaging tests is helpful in determination of the age and clinical relevance of the thrombus especially in non-symptomatic patients Due to this impossibility to determine whether the incidentally observed thrombosis is acute chronic or even an imaging artefact the vast majority of patients with incidental SVT are treated with often lifelong anticoagulants It is widely acknowledged that this practice likely results in overdiagnosis and unjust exposure to anticoagulant therapy with associated risk of bleeding An alternative imaging technique for more accurate diagnosis of SVT is MR Direct hrombus Imaging MRDTI This technique is in an advanced stage of development Theia study NCT02262052 supported by TSN grant 2013-02 and is close to implementation in clinical practice The method is based on the formation of methemoglobin in a fresh thrombus leading to shortening of the T1 signal It does not require contrast dye Both the diagnostic accuracy sensitivity 97-100 specificity 100 as well as the inter-observer agreement of MRDTI for first and recurrent DVT of the leg were reported to be excellent kappa 089-098 Moreover it was shown to accurately differentiate acute from chronic thrombosis There is an unquestionable need for improved diagnostic approaches for incidental SVT The researchers plan to evaluate the MRDTI technique that has been shown to be accurate in other settings of difficult-to-diagnosis venous thrombosis for the notoriously challenging diagnosis of incidental SVT This study targets an important unmet need and will provide the basis for precision medicine for patients with SVT in the near future ie the possibility of assessment of the age of the thrombus in patients with incidental SVT which is of utmost importance for determination of the indication for anticoagulant therapy
Study design
This study is a prospective diagnostic proof of concept study to explore the diagnostic accuracy of MRDTI in the diagnostic management of acute and chronic SVT This will be achieved by performing MRDTI scans to adjust and optimize the DTI scan sequence in 3-5 patients with confirmed acute SVT If a reproducible clearly positive DTI signal is achieved in all patients the study can proceed with the inclusion of cohort 1 and 2 ie 35 patients with confirmed acute SVT and in 35 patients with confirmed chronic SVT All scans will be evaluated post-hoc by expert readers blinded for the final diagnosis It is predetermined that at least five patients of each SVT site PVT SpVT and BCS and at least five patients of each SVT risk factor oncologic post-surgical and inflammatoryinfectious will be included To make sure that cohort 1 is generally similar to cohort 2 frequency matching will be performed in which all controls will be selected to get the same distribution according to SVT site and risk factor as cases
Splanchnic vein thrombosis SVT is one of the manifestations of unusual site venous thromboembolism VTE SVT includes portal vein thrombosis PVT mesenteric vein hrombosis MVT splenic vein thrombosis SpVT and the Budd-Chiairi syndrome BCSThere is no validated clinical algorithm for the diagnosis of SVT and there are no specific laboratory tests available to confirm or rule out the disease Particularly D-dimer tests do not have a role in the diagnosis of SVT due to its low specificity and the high percentage of false positive results especially in patients with cancer liver cirrhosis or underlying inflammatory conditions present in more than half of the total SVT population Thus the diagnosis of SVT relies on imaging tests alone Whereas Doppler ultrasound is the imaging test of choice for most forms of SVT its sensitivity is only 90 as is the sensitivity of CT angiography CTA MR angiography MRA has been reported to have 90-100 sensitivity for SVT but this technique is limited by the need to administer a contrast agent Furthermore in studies evaluating the accuracy of MRA for the diagnose of SVT gold standard for SVT surgical validation was lacking Importantly many of SVT diagnoses in clinical practice up to 30 are incidental findings ie findings on imaging tests of the abdomen performed for another reason than suspected SVT Whereas the diagnosis of symptomatic SVT is often challenging the correct diagnosis of acute versus chronic SVT is even more difficult as neither of the current available imaging tests is helpful in determination of the age and clinical relevance of the thrombus especially in non-symptomatic patients Due to this impossibility to determine whether the incidentally observed thrombosis is acute chronic or even an imaging artefact the vast majority of patients with incidental SVT are treated with often lifelong anticoagulants It is widely acknowledged that this practice likely results in overdiagnosis and unjust exposure to anticoagulant therapy with associated risk of bleeding An alternative imaging technique for more accurate diagnosis of SVT is MR Direct hrombus Imaging MRDTI This technique is in an advanced stage of development Theia study NCT02262052 supported by TSN grant 2013-02 and is close to implementation in clinical practice The method is based on the formation of methemoglobin in a fresh thrombus leading to shortening of the T1 signal It does not require contrast dye Both the diagnostic accuracy sensitivity 97-100 specificity 100 as well as the inter-observer agreement of MRDTI for first and recurrent DVT of the leg were reported to be excellent kappa 089-098 Moreover it was shown to accurately differentiate acute from chronic thrombosis There is an unquestionable need for improved diagnostic approaches for incidental SVT The researchers plan to evaluate the MRDTI technique that has been shown to be accurate in other settings of difficult-to-diagnosis venous thrombosis for the notoriously challenging diagnosis of incidental SVT This study targets an important unmet need and will provide the basis for precision medicine for patients with SVT in the near future ie the possibility of assessment of the age of the thrombus in patients with incidental SVT which is of utmost importance for determination of the indication for anticoagulant therapy
Study design
This study is a prospective diagnostic proof of concept study to explore the diagnostic accuracy of MRDTI in the diagnostic management of acute and chronic SVT This will be achieved by performing MRDTI scans to adjust and optimize the DTI scan sequence in 3-5 patients with confirmed acute SVT If a reproducible clearly positive DTI signal is achieved in all patients the study can proceed with the inclusion of cohort 1 and 2 ie 35 patients with confirmed acute SVT and in 35 patients with confirmed chronic SVT All scans will be evaluated post-hoc by expert readers blinded for the final diagnosis It is predetermined that at least five patients of each SVT site PVT SpVT and BCS and at least five patients of each SVT risk factor oncologic post-surgical and inflammatoryinfectious will be included To make sure that cohort 1 is generally similar to cohort 2 frequency matching will be performed in which all controls will be selected to get the same distribution according to SVT site and risk factor as cases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None