Treatment Using 177Lu-DOTA-EB-TATE in Patients With Advanced Neuroendocrine Tumors

Summary

This is a prospective study to investigate the long-lasting radiolabeled somatostatin analogue based peptide receptor radionuclide therapy and evaluate response to 177Lu-DOTA-EB-TATE in patients with advanced metastatic neuroendocrine tumors. Different groups with doses of 0.37GBq-0.74GBq (10-20 mCi) and 1.85GBq (50 mCi)of 177Lu-DOTA-EB-TATE, 3.7GBq (100 mCi)of 177Lu-DOTA-TATE will be injected intravenously. Besides, we evaluated the safety and dosimetry of 3.7GBq (100 mCi) of 177Lu-DOTA-EB-TATE with and without amino acid infusion. All patients will undergo 68Ga-DOTATATE PET/CT scans before and after the treatment.

Conditions

• Neuroendocrine Tumors

Interventions

DRUG

177Lu-DOTA-EB-TATE 1

The patients were intravenously injected with single dose 0.37GBq-0.74GBq (10-30 mCi) of 177Lu-DOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment.

DRUG

177Lu-DOTA-TATE

The patients were intravenously injected with single dose 3.7GBq (100 mCi) of 177Lu-DOTA-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment.

DRUG

177Lu-DOTA-EB-TATE 2

The patients were intravenously injected with single dose 1.85GBq (50 mCi) of 177Lu-DOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment.

DRUG

177Lu-DOTA-EB-TATE 3

The patients were intravenously injected with single dose 3.7GBq (100 mCi) of 177Lu-DOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment.

DRUG

3.7 GBq (100 mCi) of 177Lu-DOTA-EB-TATE with amino acids (lysine and arginine)

The patients were intravenously injected with 3.7GBq (100 mCi) of 177Lu-DOTA-EB-TATE and amino acids (lysine and arginine).

DRUG

3.7 GBq (100 mCi) of 177Lu-DOTA-EB-TATE without amino acids (lysine and arginine)

The patients were intravenously injected with 3.7GBq (100 mCi) of 177Lu-DOTA-EB-TATE without amino acids (lysine and arginine).

Sponsors & Collaborators

• Peking Union Medical College Hospital

  lead OTHER

Principal Investigators

• Zhaohui Zhu, M.D.,PhD · Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-30

Primary Completion

2022-12-31

Completion

2023-05-01

Countries

• China

Study Locations