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Effect of Lu177-dotatate in meningioma

Phase 2
Conditions
Meningioma.
Malignant neoplasm of meninges, unspecified
C70.9
Registration Number
IRCT20190623043986N1
Lead Sponsor
Shiraz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
10
Inclusion Criteria

Pathologically-proved case of meningioma
Radiologic evidence of recurrence after at least two surgeries with no response to other standard therapies
Sufficient radiotracer uptake in the Tc99m-octreotide scan
Hemoglobulin (HB)>8 g/dl
White blood cell count (WBC) > 2500 /mm3
platelet count>70000 /mm3
Glomerular filtration rate (GFR) > 50ml/min
Consent to participate in the study
Life expectancy more than 6 months

Exclusion Criteria

Pregnancy or lactation
Being candidate for other therapeutic measures
Development of unpredictable complications or other limiting or severe diseases
Severe hematologic complications
Severe renal complications

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in tumor size based on MRI findings. Timepoint: Before and during 3-6 months after therapy. Method of measurement: Brain MRI.;Change in radiotracer tumoral uptake based on Tc99m-octreotide scan. Timepoint: Before and during 3-6 months after therapy. Method of measurement: Tc99m-ocreotide scan.;Hematologic toxicity. Timepoint: 4-5 weeks after each cycle. Method of measurement: Complete blood count (CBC).;Renal toxicity. Timepoint: 4-5 weeks after each cycle. Method of measurement: Measurement of creatinine by laboratory test.
Secondary Outcome Measures
NameTimeMethod
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