Clinical trial · Interventional
Study to Assess the Safety and Effectiveness of Novel Radiopharmaceutical Terbium-161 DOTATATE in Metastatic Neuroendocrine Tumors
Terbium-161 DOTATATE in Metastatic Neuroendocrine Tumors: Assessment of Safety and Efficacy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Gastro-enteropancreatic Neuro-endocrine tumors (GEP-NETs) are rare slow-growing cancers which commonly involve the abdominal organs like liver, stomach, intestines and pancreas. Their incidence has been documented to have increased over the last decade, thus resulting in treatment options being developed to treat these cancers. These cancers spread commonly to the liver, followed by lungs, bones and other sites. Depending on the extent of disease seen on scan, treatment is planned. Patients are advised Peptide Receptor Radionuclide Therapy (PRRT), which is the current standard of treatment for metastatic GEP-NETs. Radio-isotopes labeled to octreotide analogs bind to somatostatin receptors on surface of cancer cells and deliver radiation to the cancer cells when injected into the body. Lu-177 (Lutetium-177) is one such radioisotope which has been used for tagging to the octreotide and is known as Lu-177 DOTATATE PRRT, which is now routinely used in clinical practice. Terbium-161 is another radioisotope which can be labeled to octreotide and used for PRRT. It has advantages over Lu-177 such that it specifically reaches the tumor sites and does not affect the surrounding normal cells, due to its higher penetrating capacity and shorter range of travel. This will benefit patients as the effectiveness of PRRT will be higher with lesser side effects. However, the investigators can only do this by performing a study. Response to treatment can be evaluated by performing scans and side effects, if any can be studied by performing blood tests.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Neuroendocrine Tumors | Neuroendocrine Tumor | CURATED_BROADER | 0.78 |
| Neuroendocrine Neoplasms (Tumours) | Neuroendocrine Neoplasm | ONTOLOGY_EXACT | 0.85 |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Terbium 161 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Terbium 161 DOTATATE PRRT
- description
- Peptide Receptor Radionuclide Therapy with 7.4 GBq of Terbium 161 DOTATATE administered every 6-8 weeks
- interventionNames
- Drug: Terbium 161
Primary outcomes (1)
- measure
- Disease control rate
- timeFrame
- 4-6 weeks
- description
- Disease control rate will be measured as a primary endpoint. It is percentage of patients achieving complete or partial response or stable disease on Ga-68 DOTATATE PET/CT. Response assessment will be done using RECIST 1.1 for solid tumors. Non-PD (non-disease progression) after one session of Tb-161 therapy will be eligible for the second session. Patients showing CR with no residual measurable disease will not undergo a second session of therapy. Patients with PD after 1 cycle of Tb-161 DOTATATE therapy will not continue in the study
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female, age greater than 18 years * Histopathological diagnosis of well-differentiated GEP-NET * Positive Ga-68-DOTANOC PET/CT, Krennings score \>/=3 * Locally advanced/inoperable disease or metastatic disease * Patient who have shown disease progression with Lu-177 DOTATATE PRRT * Karnofsky performance-status score of at least 60 or ECOG performance status \</=2 * Life expectancy greater than 6 months Exclusion Criteria: * Serum creatinine level of more than 1.6 mg/dl or a creatinine clearance of less than 50 ml/min * Hemoglobin level of less than 8.0 g per deciliter * Red blood cell count less than 300,000/cubic millimeter * White cell count of less than 2000 per cubic millimeter * Platelet count of less than 75,000 per cubic millimetre * Total bilirubin level of more than 3 times the upper limit of the normal range * Serum albumin level \> 3.0 g/dl * Pregnancy and Lactation * Patients with concurrent malignancies
References
Publications (2)
- BACKGROUNDBaum RP, Singh A, Kulkarni HR, Bernhardt P, Ryden T, Schuchardt C, Gracheva N, Grundler PV, Koster U, Muller D, Prohl M, Zeevaart JR, Schibli R, van der Meulen NP, Muller C. First-in-Humans Application of 161Tb: A Feasibility Study Using 161Tb-DOTATOC. J Nucl Med. 2021 Oct;62(10):1391-1397. doi: 10.2967/jnumed.120.258376. Epub 2021 Feb 5. PMID 33547209
- BACKGROUNDVerburg FA, de Blois E, Koolen S, Konijnenberg MW. Replacing Lu-177 with Tb-161 in DOTA-TATE and PSMA-617 therapy: potential dosimetric implications for activity selection. EJNMMI Phys. 2023 Nov 10;10(1):69. doi: 10.1186/s40658-023-00589-w. PMID 37947917