Actively Recruiting
Treatment of Recurrent or Progressive Meningiomas With the Radiolabelled Somatostatin Antagonist 177Lu-satoreotide
Led by University Hospital, Basel, Switzerland · Updated on 2025-04-13
18
Participants Needed
1
Research Sites
297 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Basel, Switzerland
Lead Sponsor
S
Swiss Cancer League
Collaborating Sponsor
AI-Summary
What this Trial Is About
Meningiomas are known to be the most frequent intracranial neoplasms and account for approx. 25-33% of all intracranial tumours.Targeted radionuclide therapy with radiolabelled somatostatin analogues, also called Peptide Receptor Radionuclide Therapy (PRRT), has proven to be an effective treatment in metastatic intestinal neuroendocrine tumours and is currently used in advanced, recurrent or progressive meningiomas with promising results. In this study, the therapeutic index of a standard and newly developed radiolabelled somatostatin antagonist will be evaluated and compared in PRRT. In a second step, safety and efficacy of the latter will be assessed.
CONDITIONS
Official Title
Treatment of Recurrent or Progressive Meningiomas With the Radiolabelled Somatostatin Antagonist 177Lu-satoreotide
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age over 18 years
- Female participants able to become pregnant must use effective contraception during and for 3 months after treatment
- Male participants must use effective contraception during and for 3 months after treatment
- Karnofsky Performance Status of 60 or higher
- Histologically or clinically confirmed recurrent or progressive meningioma
- No other standard treatment options available
- Tumor measurable by RECIST v1.1 with minimum diameter of 1.0 cm
- Confirmed somatostatin receptor expression on 68Ga-DOTATOC PET/CT scan
- Blood counts and organ function within specified limits: leucocytes 63 310^9/L, hemoglobin 63 80 g/L, thrombocytes 63 9010^9/L, estimated glomerular filtration rate 63 50 ml/min, albumin > 25 g/L, liver enzymes (ALT, AST, AP) 5 times upper limit, bilirubin 2 times upper limit
You will not qualify if you...
- Known intolerance to 177Lu, DOTA, JR11, TOC, or components of study drugs
- Active infection or serious infection within past 4 weeks
- Use of other investigational drugs within 60 days before first treatment
- Prior or planned therapeutic radiopharmaceutical treatment within 8 half-lives of the radionuclide
- Extensive radiotherapy involving bone marrow within past 3 months
- Chemotherapy within past 2 months
- Pregnant or breastfeeding
- Uncontrolled significant medical, psychiatric, or surgical conditions that risk safety or compliance
- Mental conditions preventing understanding of study or uncooperative behavior
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Basel, Department of Neurosurgery
Basel, Canton of Basel-City, Switzerland, 4031
Actively Recruiting
Research Team
D
Damian Wild, Prof. Dr. med.
CONTACT
D
Dominik Cordier, PD Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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