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

• ClinicalTrials.gov Identifier: NCT03478358
• Recruitment Status: Recruiting
• First Posted: March 27, 2018
• Last Update Posted: July 9, 2019
• Sponsor: Peking Union Medical College Hospital
• Collaborator: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Information provided by (Responsible Party): Peking Union Medical College Hospital

Tracking Information

• First Submitted Date: February 5, 2018
• First Posted Date: March 27, 2018
• Last Update Posted Date: July 9, 2019
• Actual Study Start Date: April 30, 2017
• Estimated Primary Completion Date: December 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 23, 2018)

Change of standardized uptake value of 68Ga-DOTA-TATE before and after the treatment in metastatic neuroendocrine tumors [ Time Frame: 1 year ]

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.

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03478358 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment Using 177Lu-DOTA-EB-TATE in Patients With Advanced Neuroendocrine Tumors
• Official Title: Treatment of a Long-lasting Radiolabeled Somatostatin Analogue 177Lu-DOTA-EB-TATE in Patients With Advanced Metastatic Neuroendocrine Tumors
• Brief Summary: This is an open-label, non-controlled, non-randomized study to investigate the long-lasting radiolabeled somatostatin analogue based peptide receptor radionuclide therapy and evaluate response to 177Lu-DOTAEB-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. All patients will undergo 68Ga-DOTATATE PET/CT scans before and after the treatment.
• Detailed Description: Neuroendocrine tumors (NETs) are a heterogeneous group of neoplasms that can develop anywhere in the body and arise from neuroendocrine cells throughout the endocrine system. The most recent NCCN guidelines for unresectable and metastatic NET recommend somatostatin analogues as first-line treatment, but do not recommend a particular treatment sequence for the remaining therapies. Radiolabeled somatostatin analogue therapy, also known as peptide receptor radionuclide therapy has become a well-accepted treatment for patients with well to moderately differentiated unresectable or metastatic NETs and disease progression after first-line treatment. However, a major problem in the therapeutic use of 177Lu-Dotatate has been its short half-life and fast rate of clearance. This study was designed to compare the efficacy of a long-lasting radiolabeled somatostatin analogue 177Lu-DOTA-EB-TATE with 177Lu-DOTA-TATE in patients with advanced metastatic neuroendocrine tumors.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Neuroendocrine Tumors

Intervention

• 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.

Study Arms

• Experimental: 177Lu-DOTA-EB-TATE 1
  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.
  Intervention: Drug: 177Lu-DOTA-EB-TATE 1
• Experimental: 177Lu-DOTA-EB-TATE 2
  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.
  Intervention: Drug: 177Lu-DOTA-EB-TATE 2
• Experimental: 177Lu-DOTA-EB-TATE 3
  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.
  Intervention: Drug: 177Lu-DOTA-EB-TATE 3
• Experimental: 177Lu-DOTA-TATE
  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.
  Intervention: Drug: 177Lu-DOTA-TATE

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 23, 2018): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2019
• Estimated Primary Completion Date: December 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• The exclusion criteria were a serum creatinine level of more than 150 μmol per liter, baseline measured GFR of less than 50 mL/min/1.73 m2, determined by 99mTc-DTPA renal function examination, a hemoglobin level of less than 8.0 g/dl, a white-cell count of less than 2.0× 109/L, a platelet count of less than 75 × 109/L, a total bilirubin level of more than 3 times the upper limit of the normal range and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia, and pregnancy or breastfeeding.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Hao Wang, PhD; +86 10 69154196; 474556259@qq.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03478358
• Other Study ID Numbers: PekingUMCH-NM018
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Peking Union Medical College Hospital
• Study Sponsor: Peking Union Medical College Hospital
• Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Investigators

• Study Chair: Zhaohui Zhu, M.D.,PhD; Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

• PRS Account: Peking Union Medical College Hospital
• Verification Date: May 2019