A single arm open-label multicenter phase II study of 177Lu-DOTATATE radionuclide in adults with progressive or high-risk meningioma

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Progressive Or High-risk Meningioma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) For grade I meningioma, subjects must have: i. Progressive disease after at least surgical resection and radiotherapy, as defined as an increase in size of the measurable primary lesion (bidirectional area) on imaging by 25% or more between scans separated by no more than 24 months. or ii. Progressive residual tumor after maximal safe resection, be located at or near critical organs at-risk [24] and considered to be high-risk for radiation injury by the treating investigator. Prior external beam radiotherapy is not required for these subjects. b. For Grade II or III meningioma, subjects must have either: i. Progressive disease after at surgical resection and radiotherapy, as defined as an increase in size of the measurable primary lesion (bi-directional area) on imaging by 25% or more between scans separated by no more than 24 months or ii. Residual measurable disease after surgery without requirement of progression. 2) Positive 68Ga-DOTATATE uptake on PET-MRI 3) 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. 4) There is no limit on the number of prior surgeries, radiation therapy, radiosurgery treatments or systemically administered therapeutic agents.

You may not be eligible for this study if the following are true:

  • 1) Participants with a clinical diagnosis of NF2 (either by NIH or Manchester criteria) or with a molecular diagnosis of NF2. 2) Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. 3) Peptide receptor radionuclide therapy at any time prior to registration. 4) Known hypersensitivity to somatostatin analogues or any component of the 68Ga- DOTATATE or 177Lu-DOTATATE formulations.


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