Study to Assess the Safety and Effectiveness of Novel Radiopharmaceutical Terbium-161 DOTATATE in Metastatic Neuroendocrine Tumors
TENET
Terbium-161 DOTATATE in Metastatic Neuroendocrine Tumors: Assessment of Safety and Efficacy
2 other identifiers
interventional
20
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2026
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2026
CompletedFirst Posted
Study publicly available on registry
February 11, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2029
February 11, 2026
February 1, 2026
2 years
January 23, 2026
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease control rate
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
4-6 weeks
Secondary Outcomes (3)
Quality of Life assessment
Before therapy, at 4 weeks and 8 weeks after each therapy session.
Safety Assessment
2 weeks, 4 weeks and 6 weeks after each therapy
Quality of Life assessment using QLQ-GI.NET21 questionnaire
Before therapy, at 4 weeks and 8 weeks after each therapy session.
Study Arms (1)
Terbium 161 DOTATATE PRRT
EXPERIMENTALPeptide Receptor Radionuclide Therapy with 7.4 GBq of Terbium 161 DOTATATE administered every 6-8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Tata Memorial Hospital, Mumbai, India
Mumbai, Maharashtra, 400012, India
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Navi Mumbai, Maharashtra, 410210, India
Related Publications (2)
Baum 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: 33547209BACKGROUNDVerburg 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: 37947917BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ameya Puranik, DNB
Tata Memorial Hospital, Mumbai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 23, 2026
First Posted
February 11, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
February 28, 2028
Study Completion (Estimated)
February 28, 2029
Last Updated
February 11, 2026
Record last verified: 2026-02