Systemic Lupus ErythematosusNCT00527176
Pulse Corticosteroid Therapy and Effect on Brain Water Diffusivity
An observational study of Systemic Lupus Erythematosus, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
In daily clinical use, pulse high dosis corticosteroids are used to treat cerebral edema in different pathological situations ( surgery, trauma, tumors...). Dehydration can theorically concern extra-cellular or intracellular water, or both. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- Not given
- Where
- 1 siteBelgium
- Study dates
- Sep 2007to Sep 2007
- 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
Who may be able to join
- Systemic Lupus Erythematosus
- normal neurological exam
- informed consent
- 18 yo or more
Who cannot join
- abnormal neurological exam
- younger than 18 years old
Trial locations and contacts
1 site in 1 country.
Denis J Rommel, MD contact
Belgium1 site, 1 recruiting
- Recruiting
Clinique Universitaire St LUC
Brussels, 1200
About this study
In daily clinical use, pulse high dosis corticosteroids are used to treat cerebral edema in different pathological situations ( surgery, trauma, tumors...). Dehydration can theorically concern extra-cellular or intracellular water, or both.
The relative proportion of those two components are not known, as well their kinetics.
Read more
Diffusion Weighted Imaging ( DWI) is a none invasive and none toxic technique to study those phenomena.We can also study the diffusivity anisotropy not using a Gaussian distribution but rather a non- gaussian one, more close to the reality ( q Space Imaging ).
Finally, we can study the compartment redistribution between slow and rapid water molecules diffusion by bi-exponential decomposition of the diffusion signal, corresponding, theorically, respectively to the intra- and extra-cellular component.
Hypothesis : The high dosis steroid pulse therapy modifies or not the water free diffusion in DWI and qSI ? Is there a modification in the diffusivity of both rapid and slow component ?
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, Corticosteroid, Pulse therapy, Diffusion weighted imaging, q Space Imaging
- Medical subject headings
- Lupus Erythematosus, Systemic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Defined population
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Investigators
- Thierry Duprez, MD, Study director, Université Catholique de LouvainDenis Rommel, MD, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527176
- Sponsor's protocol ID
- B40320072108
- Status last verified
- Sep 2007
- First submitted
- 7 Sep 2007
- Last updated
- 10 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bosma GP, Huizinga TW, Mooijaart SP, Van Buchem MA. Abnormal brain diffusivity in patients with neuropsychiatric systemic lupus erythematosus. AJNR Am J Neuroradiol. 2003 May;24(5):850-4.
PubMed 12748084Moritani T, Shrier DA, Numaguchi Y, Takahashi C, Yano T, Nakai K, Zhong J, Wang HZ, Shibata DK, Naselli SM. Diffusion-weighted echo-planar MR imaging of CNS involvement in systemic lupus erythematosus. Acad Radiol. 2001 Aug;8(8):741-53. doi: 10.1016/S1076-6332(03)80581-0.
PubMed 11508753Steens SC, Steup-Beekman GM, Bosma GP, Admiraal-Behloul F, Olofsen H, Doornbos J, Huizinga TW, van Buchem MA. The effect of corticosteroid medication on quantitative MR parameters of the brain. AJNR Am J Neuroradiol. 2005 Nov-Dec;26(10):2475-80.
PubMed 16286387Dehmeshki J, Van Buchem MA, Bosma GP, Huizinga TW, Tofts PS. Systemic lupus erythematosus: diagnostic application of magnetization transfer ratio histograms in patients with neuropsychiatric symptoms--initial results. Radiology. 2002 Mar;222(3):722-8. doi: 10.1148/radiol.2223010413.
PubMed 11867791Peterson PL, Howe FA, Clark CA, Axford JS. Quantitative magnetic resonance imaging in neuropsychiatric systemic lupus erythematosus. Lupus. 2003;12(12):897-902. doi: 10.1191/0961203303lu499oa.
PubMed 14714908Moritani T, Hiwatashi A, Shrier DA, Wang HZ, Numaguchi Y, Westesson PL. CNS vasculitis and vasculopathy: efficacy and usefulness of diffusion-weighted echoplanar MR imaging. Clin Imaging. 2004 Jul-Aug;28(4):261-70. doi: 10.1016/S0899-7071(03)00191-8.
PubMed 15246475Sun SS, Huang WS, Chen JJ, Chang CP, Kao CH, Wang JJ. Evaluation of the effects of methylprednisolone pulse therapy in patients with systemic lupus erythematosus with brain involvement by Tc-99m HMPAO brain SPECT. Eur Radiol. 2004 Jul;14(7):1311-5. doi: 10.1007/s00330-003-2166-3. Epub 2003 Dec 9.
PubMed 14663624
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Corticosteroid Therapy and Effect on Brain Water Diffusivity
- ClinicalTrials.gov ID
- NCT00527176
- Acronym / sponsor ID
- B40320072108
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, Corticosteroid, Pulse therapy, Diffusion weighted imaging, q Space Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Study start
- Sep 2007
- Study completion
- Sep 2007
- First posted
- 10 Sep 2007 (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.
In daily clinical use, pulse high dosis corticosteroids are used to treat cerebral edema in different pathological situations ( surgery, trauma, tumors...). Dehydration can theorically concern extra-cellular or intracellular water, or both.
The relative proportion of those two components are not known, as well their kinetics.
Diffusion Weighted Imaging ( DWI) is a none invasive and none toxic technique to study those phenomena.We can also study the diffusivity anisotropy not using a Gaussian distribution but rather a non- gaussian one, more close to the reality ( q Space Imaging ).
Finally, we can study the compartment redistribution between slow and rapid water molecules diffusion by bi-exponential decomposition of the diffusion signal, corresponding, theorically, respectively to the intra- and extra-cellular component.
Hypothesis : The high dosis steroid pulse therapy modifies or not the water free diffusion in DWI and qSI ? Is there a modification in the diffusivity of both rapid and slow component ?
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Systemic Lupus Erythematosus
- normal neurological exam
- informed consent
- 18 yo or more
Key exclusion criteria (2 listed)
- abnormal neurological exam
- younger than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2007.
- Background: PubMed 12748084Bosma GP, Huizinga TW, Mooijaart SP, Van Buchem MA. Abnormal brain diffusivity in patients with neuropsychiatric systemic lupus erythematosus. AJNR Am J Neuroradiol. 2003 May;24(5):850-4.
- Background: PubMed 11508753Moritani T, Shrier DA, Numaguchi Y, Takahashi C, Yano T, Nakai K, Zhong J, Wang HZ, Shibata DK, Naselli SM. Diffusion-weighted echo-planar MR imaging of CNS involvement in systemic lupus erythematosus. Acad Radiol. 2001 Aug;8(8):741-53. doi: 10.1016/S1076-6332(03)80581-0.
- Background: PubMed 16286387Steens SC, Steup-Beekman GM, Bosma GP, Admiraal-Behloul F, Olofsen H, Doornbos J, Huizinga TW, van Buchem MA. The effect of corticosteroid medication on quantitative MR parameters of the brain. AJNR Am J Neuroradiol. 2005 Nov-Dec;26(10):2475-80.
- Background: PubMed 11867791Dehmeshki J, Van Buchem MA, Bosma GP, Huizinga TW, Tofts PS. Systemic lupus erythematosus: diagnostic application of magnetization transfer ratio histograms in patients with neuropsychiatric symptoms--initial results. Radiology. 2002 Mar;222(3):722-8. doi: 10.1148/radiol.2223010413.
- Background: PubMed 14714908Peterson PL, Howe FA, Clark CA, Axford JS. Quantitative magnetic resonance imaging in neuropsychiatric systemic lupus erythematosus. Lupus. 2003;12(12):897-902. doi: 10.1191/0961203303lu499oa.
- Background: PubMed 15246475Moritani T, Hiwatashi A, Shrier DA, Wang HZ, Numaguchi Y, Westesson PL. CNS vasculitis and vasculopathy: efficacy and usefulness of diffusion-weighted echoplanar MR imaging. Clin Imaging. 2004 Jul-Aug;28(4):261-70. doi: 10.1016/S0899-7071(03)00191-8.
- Background: PubMed 14663624Sun SS, Huang WS, Chen JJ, Chang CP, Kao CH, Wang JJ. Evaluation of the effects of methylprednisolone pulse therapy in patients with systemic lupus erythematosus with brain involvement by Tc-99m HMPAO brain SPECT. Eur Radiol. 2004 Jul;14(7):1311-5. doi: 10.1007/s00330-003-2166-3. Epub 2003 Dec 9.
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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.
Denis J Rommel, MD contact
Thierry Duprez, MD study director
Université Catholique de Louvain
Denis Rommel, MD principal investigator
Université Catholique de Louvain
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 Systemic Lupus Erythematosus, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 4 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 10 Sep 2007. 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 Belgium. 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?
Contact Thierry Duprez, MD (+ 32 2 764 29 19, duprez@rdgn.ucl.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00527176, which also lists 7 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 10 Sep 2007.