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

NCT03478358 | Unknown Phase 1

• 1 other identifier: PekingUMCH-NM018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change of standardized uptake value of 68Ga-DOTA-TATE before and after the treatment in metastatic neuroendocrine tumors

  The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value before and after the treatment in metastatic neuroendocrine tumors will be measured.

  1 year

• the safety of 3.7GBq of 177Lu-DOTA-EB-TATE with and without amino acid infusion.

  Hematological parameters, liver, and renal function at baseline, 1 week and 4 weeks after PRRT were tested. 99mTc-DTPA dynamic renal imaging for the determination of the glomerular filtration rate (GFR) was performed at baseline and 8 weeks after each cycle of PRRT.

  1 year

Secondary Outcomes (1)

• the dosimetry of 3.7GBq of 177Lu-DOTA-EB-TATE with and without amino acid infusion.

  1 year

Study Arms (6)

177Lu-DOTA-EB-TATE 1

EXPERIMENTAL

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

Drug: 177Lu-DOTA-EB-TATE 1

177Lu-DOTA-EB-TATE 2

EXPERIMENTAL

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

Drug: 177Lu-DOTA-EB-TATE 2

177Lu-DOTA-EB-TATE 3

EXPERIMENTAL

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

Drug: 177Lu-DOTA-EB-TATE 3

177Lu-DOTA-TATE

EXPERIMENTAL

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

Drug: 177Lu-DOTA-TATE

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

Interventions

177Lu-DOTA-EB-TATE 1 DRUG

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.

177Lu-DOTA-EB-TATE 1

177Lu-DOTA-TATE DRUG

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.

177Lu-DOTA-TATE

177Lu-DOTA-EB-TATE 2 DRUG

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.

177Lu-DOTA-EB-TATE 2

177Lu-DOTA-EB-TATE 3 DRUG

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.

177Lu-DOTA-EB-TATE 3

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

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

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

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

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

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults who had neuroendocrine tumors and had metastasized, that were with histologically confirmed, inoperable and had showed disease progression according to Response Evaluation Criteria in Solid Tumors \[RECIST\]. Tumors were with well-differentiated histologic features and a Ki67 index of 0 to 20%. Target tumors were selected from CT, MRI, and 68Ga-DOTA-TATE PET/CT, with confirmed somatostatin receptorexpressing and at least one lesion has higher uptake than that of normal liver parenchyma on 68Ga-DOTA-TATE PET imaging within 1 weeks.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Related Publications (2)

• Jiang Y, Liu Q, Wang G, Zhang J, Zhu Z, Chen X. Evaluation of Safety, Biodistribution, and Dosimetry of a Long-Acting Radiolabeled Somatostatin Analog 177 Lu-DOTA-EB-TATE With and Without Amino Acid Infusion. Clin Nucl Med. 2023 Jun 1;48(6):e289-e293. doi: 10.1097/RLU.0000000000004642. Epub 2023 Apr 18.

  PMID: 37075254 DERIVED

• Liu Q, Cheng Y, Zang J, Sui H, Wang H, Jacobson O, Zhu Z, Chen X. Dose escalation of an Evans blue-modified radiolabeled somatostatin analog 177Lu-DOTA-EB-TATE in the treatment of metastatic neuroendocrine tumors. Eur J Nucl Med Mol Imaging. 2020 Apr;47(4):947-957. doi: 10.1007/s00259-019-04530-1. Epub 2019 Dec 12.

  PMID: 31832728 DERIVED

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

(177)Lu-DOTA-EB-TATE; Amino Acids; Lysine; Arginine

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Amino Acids, Basic; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Zhaohui Zhu, M.D.,PhD

  Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

  STUDY CHAIR

Central Study Contacts

Hao Wang, PhD

CONTACT

+86 10 69154196; 474556259@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: March 27, 2018
• Study Start: April 30, 2017
• Primary Completion: December 31, 2022
• Study Completion: May 1, 2023
• Last Updated: August 31, 2022

Record last verified: 2022-08

Locations

CN (1)