| CTRI Number |
CTRI/2026/01/101072 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Radionuclide Therapy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TeNET Study: Phase 2 research study check how safe and effective a new treatment called Terbium-161 DOTATATE is for patients with advanced metastatic neuroendocrine tumors |
|
Scientific Title of Study
|
TeNET Study: Phase 2 Study to Assess Safety and Efficacy of Terbium-161 DOTATATE in Metastatic Neuroendocrine Tumors |
| Trial Acronym |
TeNET |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ameya Puranik |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Dept of Nuclear Medicine, Tata Memorial Hospital
Dr E Borges Marg, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09619811125 |
| Fax |
|
| Email |
ameya2812@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ameya Puranik |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Dept of Nuclear Medicine, Tata Memorial Hospital
Dr E Borges Marg, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09619811125 |
| Fax |
|
| Email |
ameya2812@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ameya Puranik |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Dept of Nuclear Medicine, Tata Memorial Hospital
Dr E Borges Marg, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09619811125 |
| Fax |
|
| Email |
ameya2812@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural funding from Institutional Ethics Committee, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai 400012, India or
Extramural funding |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr E Borges Marg, Parel, Mumbai 400012, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ameya Puranik |
Tata Memorial Hospital |
Dept of Nuclear Medicine, Tata Memorial Hospital
Dr E Borges Marg, Parel
Mumbai
MAHARASHTRA |
9619811125
ameya2812@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Tata Memorial Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C7A0||Malignant carcinoid tumors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicabl |
| Intervention |
Terbium 161 |
Radionuclide therapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Histopathological diagnosis of well differentiated GEP NET
Positive Ga-68-DOTANOC PET CT with Krennings score greater than or equal to 3
Locally advanced or inoperable disease or metastatic disease
Patient who have shown disease progression with Lu177 DOTATATE PRRT
Karnofsky performance status score of at least 60 or ECOG performance status greater than or equal to 2
Life expectancy greater than 6 months
|
|
| ExclusionCriteria |
| Details |
Serum creatinine level of more than 1.6 mg per deciliter or a creatinine clearance of less than 50 ml per min
Hemoglobin level of less than 8.0 g per deciliter
Red blood cell count less than 300,000 per 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 greater than 3.0 g/dl
Pregnancy and Lactation
Patients with concurrent malignancies
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Disease control rate |
4 to 6 weeks after each cycle of Terbium 161 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety using CTCAE 5.0 |
every 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Targeted radionuclide therapy is a nuclear medicine
technique that uses radiopharmaceuticals with high affinity to
receptors or antigens on the surface of tumor cells to achieve a
therapeutic effect. TRT causes less collateral damage than external beam
radiotherapy because the RPs are selectively taken up by tumors and
their metastases delivering high doses of radiation to cancer cells and
minimizing doses to normal tissues. NETTER 1 and 2
trials have already established Peptide Receptor Radionuclide
Therapy with Lutetium177 (DOTATATE as first line TRT in
metastatic well differentiated gastroenteropancreatic neuroendocrine
tumors. At Tata Memorial Hospital, we are routinely treating patients with PRRT
with Lu 177 DOTATATE since 2019 and have completed nearly 700 cycles of
PRRT till date. The
superiority of Terbium 161 over Lu177 evolves from its basic property of emission
of Auger electrons. Most important characteristics of radioisotopes in Nuclear Medicine or
Radiation Oncology are linear energy transfer and range which are determinants
of cell damage to the target cell and normal cell respectively. Compared to
beta emissions as in Lu 177 AEs are most lethal to cancer cells when emitted near the
cell nucleus and especially when incorporated into DNA. AEs cause DNA damage
both directly and indirectly via water radiolysis. AEs can also kill targeted
cancer cells by damaging the cell membrane and producing more targeted and
lethal effects. Moreover, the important point is that since the range of
delivery of this energy is relatively shorter as compared to beta-emitters,
hence there is negligible bystander and crossfire effect, thereby causing no
damage to surrounding cells. As of today Tb 161 DOTATATE is already commercially available in India and first therapy
has already been administered, with multiple centers now starting this
treatment. Dept of Nuclear Medicine at Tata Memorial Center has already obtained approval from Atomic Energy Regulatory Board and has treated 2 patients of metastatic NET on compassionate basis
with Tb 161 DOTATATE who were refractory to Lu 177 DOTATATE. We therefore
would like to study the safety and efficacy of Tb 161 DOTATATE in patients in
metastatic NET who have shown disease progression after treatment with Lu 177
DOTATATE PRRT.
|