New treatment for neuroendocrine tumors using a targeted radiopharmaceutical
Combined Beta- Plus Auger Electron Therapy Using a Novel Somatostatin Receptor Subtype 2 Antagonist Labelled With Terbium-161 (161Tb-DOTA-LM3): Beta Plus Study
This study is testing a new targeted treatment for patients with gastroenteropancreatic neuroendocrine tumors to see if it works better than the current standard treatment.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 1 site (Basel) |
| Trial ID | NCT05359146 on ClinicalTrials.gov |
What this trial studies
This early-phase clinical trial aims to evaluate the therapeutic index of a novel radiopharmaceutical, 161Tb-DOTA-LM3, in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The study employs a randomized, cross-over design where participants will receive both 161Tb-DOTA-LM3 and the current standard treatment, 177Lu-DOTATOC, to compare their effectiveness. The trial will involve a limited number of patients, focusing on those with diagnosed and metastasized GEP-NENs. The goal is to determine if the new treatment can enhance the efficacy of peptide receptor radionuclide therapy (PRRT).
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 with diagnosed and metastasized secreting and non-secreting GEP-NENs who have no curative surgical options.
Not a fit: Patients with curable surgical options or those with non-measurable tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for managing neuroendocrine tumors, potentially improving patient outcomes.
How similar studies have performed: While peptide receptor radionuclide therapy has shown success, the specific approach using 161Tb-DOTA-LM3 is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written consent * Patients with diagnosed and metastasized secreting and non-secreting GEP-NEN (grade 1 and 2) * Absence of a curative surgical option * At least 2 measurable tumours based on RECIST 1.1 (minimal tumour diameter of 1 cm) * Documentation of a positive 68Ga-DOTATOC/-TATE positron emission tomography (PET)/CT (in vivo detection of SST2 on GEP-NENs) * Indication for PRRT * Patient of any gender and of age older than 18 * Female patients of child-bearing age (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) * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Blood parameters: h) Leucocytes ≥ 3\*109/L i) Haemoglobin ≥ 90 g/L j) Thrombocytes ≥ 90\*109/L k) Estimated glomerular filtration rate ≥ 50 ml/min or Creatinine \< 150 μmol/l l) Albumin \> 25 g/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, 161Tb, DOTA, TOC, LM3, SST analogues or against one of the components of 177Lu-DOTATOC or 161Tb-DOTA-LM3 * Bone/bone marrow metastases located in the lumbar spine if they affect the bone marrow dose estimation * 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 4 weeks before inclusion * Pregnant or breastfeeding female patients. A pregnancy test will be performed in all women of child-bearing age. * 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.
Where this trial is running
Basel
- Division of Nuclear Medicine, University Hospital Basel — Basel, Switzerland (Recruiting)
Study contacts
- Study coordinator: Julia Fricke, Dr. med.
- Email: julia.fricke@usb.ch
- Phone: +41 61 328 7688
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.