Terbium-161 DOTATATE in Metastatic Neuroendocrine Tumors: Assessment of Safety and Efficacy

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
India
Tata Memorial Hospital, Mumbai, India
RECRUITING
Mumbai
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
RECRUITING
Navi Mumbai
Contact Information
Primary
Ameya Puranik, DNB
ameya2812@gmail.com
+919619811125
Backup
Sushil Yadav, MSc
sushilyadav.crc@gmail.com
912224177000
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2029-02-28
Participants
Target number of participants: 20
Treatments
Experimental: Terbium 161 DOTATATE PRRT
Peptide Receptor Radionuclide Therapy with 7.4 GBq of Terbium 161 DOTATATE administered every 6-8 weeks
Sponsors
Leads: Tata Memorial Hospital

This content was sourced from clinicaltrials.gov