NCT04997317 Treatment of Recurrent or Progressive Meningiomas With the Radiolabelled Somatostatin Antagonist 177Lu-satoreotide
| NCT ID | NCT04997317 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Meningioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2021-04-21 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2021-04-21 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Informed Consent as documented by signature * Participants of any gender and of age \> 18 years * Female participants capable of giving birth (who are not surgically sterilized or are less than 2 years in their menopause) must use a medically accepted contraceptive and must agree to use it during and till 3 months after the treatment. As acceptable contraceptive count sexual abstinence or double contraceptive methods: hormonal contraceptive (oral, transdermal, implants or injections) in combination with barrier methods (spiral, condom, diaphragm) * Male participants must use medically accepted contraceptive during and till 3 months after treatment * The participants' Karnofsky Performance Status must be ≥ 60 * The participants must be patients with a histologically or clinically confirmed (MRI + somatostatin receptor imaging) recurrent or progressive meningioma * There must be no other standard therapeutic alternatives for the participants * The participants tumour must be measurable according to RECIST v1.1 with a minimal diameter of 1.0 cm. * The participants must have a confirmed expression of somatostatin receptor (SSTR) on 68Ga- DOTATOC positron emission computed tomography (PET)/CT scan * Blood parameter criteria are: h) Leucocytes ≥ 3\*109/L i) Haemoglobin ≥ 80 g/L j) Thrombocytes ≥ 90\*109/L k) Estimated glomerular filtration rate ≥ 50 ml/min l) Albumin \> 25g/L m) alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP): ≤ 5 times upper standard value n) Bilirubin ≤ 2 times upper standard value Exclusion Criteria: * Known intolerance against 177Lu, DOTA, JR11, TOC or against one of the components of 177Lu-DOTA-JR11 or 177Lu-DOTATOC * Ongoing infection at the screening visit or a serious infection in the past 4 weeks * Administration of another investigational product in the last 60 days before Visit 1 Day 1 * Prior or planed administration of a therapeutic radio-pharmaceutical during 8 half-lives of the used radio-pharmaceutical's radionuclide, also during the ongoing study * Any extensive Radiotherapy involving bone marrow over the last 3 months before inclusion to the study * Chemotherapy in the last 2 months before inclusion * Pregnant or breastfeeding female patients. A pregnancy test will be performed in all women of child bearing potential. * Any uncontrolled significant medical, psychiatric or surgical condition (active infection, unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, poorly controlled diabetes mellitus \[HbA1c ≥ 9%\], uncontrolled congestive heart disease, etc.) or laboratory findings that might jeopardize the patient's safety or that would limit compliance with the objectives and assessments of the study. Any mental conditions which prevent the patient from understanding the type, extent and possible consequences of the study and/or an uncooperative attitude from the patient.
Contact & Investigator
Dominik Cordier, PD Dr. med.
PRINCIPAL INVESTIGATOR
University Hospital, Basel, Switzerland
Frequently Asked Questions
Who can join the NCT04997317 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Meningioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04997317 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04997317 currently recruiting?
Yes, NCT04997317 is actively recruiting participants. Contact the research team at damian.wild@usb.ch for enrollment information.
Where is the NCT04997317 trial being conducted?
This trial is being conducted at Basel, Switzerland.
Who is sponsoring the NCT04997317 clinical trial?
NCT04997317 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Dominik Cordier, PD Dr. med. at University Hospital, Basel, Switzerland. The trial plans to enroll 18 participants.