Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma (NCT03971461) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma
United States32 participantsStarted 2019-05-15
Plain-language summary
This single arm, open-label study will evaluate the efficacy of Lutathera (177Lu-DOTATATE) administered intravenously every 8 weeks for a total of 4 doses in patients with progressive WHO I-III or residual high-risk Ga-DOTATATE PET-MRI positive meningioma. Ga-DOTATATE PET-MRI scans will be obtained prior to initiation of Lutathera treatment and 6 months after the initiation of Lutathera treatment. The latter will be performed within the 14 days prior to the last dose of Lutathera treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female subjects aged ≥ 18 years.
✓. Karnofsky Performance Status ≥ 60.
✓. Histologically confirmed diagnosis WHO grade I-III meningioma:
✓. Positive 68Ga-DOTATATE uptake on PET-MRI.
✓. Positive uptake is defined as uptake higher than the background and SUV ratios adjusted to the liver and spleen uptake (adopted from Krenning score).
✓. 68Ga-DOTATATE uptake in target lesions should be Krenning score ≥ 2.
✓. Presence of measurable disease defined as at least one lesion measuring ≥10 mm in at least one dimension by contrast-enhanced MRI performed within 30 days prior to study registration.
✓. Multifocal disease is allowed but is limited to ≤ 3 measurable intracranial mass lesions on the most recent post-contrast MRI.
Exclusion criteria
✕5. Adequate organ and bone marrow function as defined below (within 21 days of treatment initiation):