Terbium-161 DOTATATE for metastatic gastro‑enteropancreatic neuroendocrine tumors
Terbium-161 DOTATATE in Metastatic Neuroendocrine Tumors: Assessment of Safety and Efficacy
This trial tests terbium-161 DOTATATE, a targeted radioactive drug, in adults with metastatic well-differentiated GEP‑NETs who have progressed after lutetium‑177 therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Tata Memorial Hospital Government |
| Drugs / interventions | radiation |
| Locations | 2 sites (Mumbai, Maharashtra and 1 other locations) |
| Trial ID | NCT07404176 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial gives terbium‑161 labeled to DOTATATE (a somatostatin analogue) to patients with somatostatin receptor–positive metastatic well‑differentiated gastro‑enteropancreatic neuroendocrine tumors. Eligible participants are identified by Ga‑68 DOTANOC PET/CT with Krenning score ≥3 and typically have progressed after prior Lu‑177 DOTATATE PRRT. Participants receive the radiopharmaceutical and are monitored for safety, organ function, and anti‑tumor activity using imaging and clinical assessments. The study is being conducted at Tata Memorial Hospital and ACTREC in the Mumbai metropolitan area to gather preliminary efficacy and safety data for this isotope.
Who should consider this trial
Good fit: Adults (≥18 years) with histologically confirmed well‑differentiated GEP‑NETs, Ga‑68 DOTANOC PET/CT Krenning score ≥3, metastatic or inoperable disease, prior progression after Lu‑177 DOTATATE, adequate organ function, and ECOG ≤2 are ideal candidates.
Not a fit: Patients with poor organ function (significant renal impairment or cytopenias), concurrent malignancies, pregnancy or lactation, or somatostatin receptor‑negative tumors are unlikely to benefit.
Why it matters
Potential benefit: If successful, terbium‑161 DOTATATE could provide an effective PRRT option when Lu‑177 is limited and may improve tumor cell kill due to its Auger electron emissions.
How similar studies have performed: PRRT with Lu‑177 DOTATATE has proven benefit in NETTER trials, but clinical data specifically supporting terbium‑161 in patients are limited and largely based on preclinical rationale and early exploratory work.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Mumbai, Maharashtra and 1 other locations
- Tata Memorial Hospital, Mumbai, India — Mumbai, Maharashtra, India (Recruiting)
- Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) — Navi Mumbai, Maharashtra, India (Recruiting)
Study contacts
- Principal investigator: Ameya Puranik, DNB — Tata Memorial Hospital, Mumbai
- Study coordinator: Ameya Puranik, DNB
- Email: ameya2812@gmail.com
- Phone: +919619811125
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.