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Do prolactinomas influence vessel growth.


- candidate number8423
- NTR NumberNTR2511
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-sep-2010
- Secondary IDs09/294 METC AMC
- Public TitleDo prolactinomas influence vessel growth.
- Scientific TitleDo prolactinomas influence angiogenesis.
- ACRONYMEPRAS
- hypothesisProlactinomas influence angiogenesis.
- Healt Condition(s) or Problem(s) studiedProlactinoma
- Inclusion criteria1. Patients (both women and men) with active micro- or macroprolactinoma and prolactin levels > 40 ng/ml not on prolactin lowering therapy;
or
2. Patients (both women and men) with microprolactinoma currently treated with prolactin lowering therapy;
3. Age 18-60 years;
4. Written informed consent.
- Exclusion criteria1. Retinal disease;
2. Macroprolactinemia;
3. Infundibulum infiltration;
4. Diabetes mellitus type 2;
5. Pregnant women;
6. Premature atherosclerosis;
7. Use of antidepressive and antipsychotic medication;
8. Presence of co-morbidity that could affect retinal vasculature or its matrix;
9. History of hypersensitivity or allergy to fluorescein;
10. Inability to obtain SDF, fluorescein angiograms or OCTís of sufficient quality to be analyzed and graded;
11. Systemic disease with a life expectancy shorter than the duration of the study;
12. Active malignancy;
13. Inability to adhere to the protocol with regard to injection and follow-up visits;
14. Legally incompetent adult;
15. Refusal to give written informed consent;
16. Additional use of medication that could affect neo-angiogenesis.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2010
- planned closingdate1-dec-2011
- Target number of participants20
- InterventionsSDF, FAG/OCT, blood withdrawal including technique that comes with these procedures.
- Primary outcomeSDF, OCT, FAG-ICG imaging, will show changes in microcirculation.
- Secondary outcomeCoagulation.
- TimepointsDone december 1 2011.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES B.M. Sondermeijer
- CONTACT for SCIENTIFIC QUERIESDr. Stroes
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryAngiogenesis will be studied with OCT FAG in prolactinoma patients.
- Main changes (audit trail)
- RECORD7-sep-2010 - 23-sep-2010


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