Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT06955169
Eligibility Criteria:
Inclusion Criteria:
STEP 1 REGISTRATION
* Aged \>= 18 years
* Histologically confirmed diagnosis of WHO grade 1-3 meningioma
* Presence of measurable contrast-enhancing disease on gadolinium-enhanced MRI brain scan defined as at least one lesion with two perpendicular diameters measuring ≥10 mm on two or more axial slices (≤ 5 mm interslice thickness, ≤ 1 mm interslice gap) per current RANO meningioma criteria
* Progression of disease determined by local radiology review per current RANO meningioma criteria, defined as
* ≥ 15% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 6 months, or
* ≥ 25% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 12 months, or
* Development of a new measurable lesion
* The following scans must be available for submission for central radiology review:
* Pre-progression gadolinium-enhanced MRI brain scan
* Progression gadolinium-enhanced MRI brain scan
STEP 2 REGISTRATION
* Progression of disease determined by central radiology review per current RANO meningioma criteria, defined as
* ≥ 15% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 6 months, or
* ≥ 25% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 12 months, or
* Development of a new measurable lesion.
* \[68Ga\]Ga-DOTATATE uptake on PET-CT. Positive uptake is defined as uptake at least as high as liver, based on the uptake in at least one target lesion.
* If randomized to the control (standard of care) arm, both the patient and investigator must agree NOT to receive SSTR2-targeted therapy, surgical resection, or radiation therapy.
* Patients must be willing and able to undergo regular MRI scans of the brain and \[68Ga\]Ga-DOTATATE PET-CT imaging during the study.
* Patients must have recovered to CTCAE grade ≤1 or pretreatment baseline from clinically significant adverse events related to prior therapy (exclusions include alopecia, lymphopenia, sensory neuropathy ≤ grade 2, or other ≤ grade 2 not constituting a safety risk based on the investigator's judgment).
* Adequate organ and bone marrow function as defined below (within 28 days prior to step 2 registration):
* Absolute neutrophil count (ANC) ≥ 1500/mm3
* Platelet count ≥ 75,000/mm3
* Hemoglobin ≥ 8 g/dL
* Creatinine clearance (calculated by the Cockroft-Gault method) ≥40mL/min
* Total serum bilirubin ≤ 3 x ULN (except participants with Gilbert's Syndrome, who can have a total bilirubin ≤ 5 x ULN)
* Potassium within normal limits.
Exclusion Criteria:
* Patients with a clinical diagnosis of NF2-related schwannomatosis or with a known molecular diagnosis of NF2-related schwannomatosis.
* Patients with radiation-associated meningiomas.
* Patients with known intraspinal meningiomas or meningioma metastases outside the skull/spinal column.
* Prior SSTR2-targeted therapy, e.g. Somatostatin LAR or short-acting Octreotide.
* Unstable neurological symptoms requiring steroids to control symptoms at a dose of \>2 mg of dexamethasone (or equivalent) daily within 28 days prior to step 2 registration.
* Patients requiring immediate local therapy (e.g. surgical resection).
* Surgical procedure within the timeframes listed below, prior to step 2 registration.
* 28 days from any prior craniotomy
* 7 days from stereotactic biopsy Note: There is no limit to the number of prior surgical interventions
* Treatment within the timeframes specified below, prior to step 2 registration.
* 28 days (or 5 half-lives, whichever is longer) for cytotoxic chemotherapy, biologic agent, investigational agent or any other systemic agent prescribed for the purpose of treating meningioma
* 6 weeks from nitrosoureas Note: There is no limit to the number of prior systemically administered therapeutic agents.
* Prior external beam radiation, interstitial brachytherapy or stereotactic radiosurgery cumulative radiation dose of \> 70 Gy or the last dose of radiotherapy \< 24 weeks (6 months) prior to step 2 registration
* Peptide receptor radionuclide therapy at any time prior to registration.
* Known hypersensitivity to somatostatin analogues or any component of the \[68Ga\]Ga- DOTATATE or \[177Lu\]Lu-DOTATATE formulations.
* Active infection requiring current use of intravenous therapy with antibiotics.
* Active cardiovascular disease: cerebral vascular accident/stroke (≤ 6 months prior to registration), myocardial infarction (≤ 6 months prior to registration), congestive heart failure (≥ NYHA class II), unstable angina pectoris, or serious cardiac arrhythmia requiring medication.
* An active malignancy ≤ 3 years. Note: Patients with a malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
* Pregnant and/or breastfeeding patients who are unwilling to discontinue breast feeding.
* Participants of childbearing potential must have a negative pregnancy test within 14 days of study entry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06955169
Study Brief:
Protocol Section:
NCT06955169