Treatment Using 177Lu-DOTA-EB-TATE in Patients With Advanced Neuroendocrine Tumors
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- STATUS
- Recruiting
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- End date
- May 1, 2023
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- participants needed
- 60
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- sponsor
- Peking Union Medical College Hospital
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.
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. Kidney is considered one of the dose-limiting organs in peptide receptor radionuclide therapy (PRRT). Amino acid has been infused to reduce renal absorbed dose by inhibiting the proximal tubular reabsorption of the radiopeptide. 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 and evaluate the safety and dosimetry of 3.7GBq (100 mCi) of 177Lu-DOTA-EB-TATE with and without amino acid infusion.
Details
| Condition | Neuroendocrine Tumors |
|---|---|
| Treatment | 177Lu-DOTA-TATE, 177Lu-DOTA-EB-TATE 1, 177Lu-DOTA-EB-TATE 2, 177Lu-DOTA-EB-TATE 3, 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) |
| Clinical Study Identifier | NCT03478358 |
| Sponsor | Peking Union Medical College Hospital |
| Last Modified on | 7 October 2022 |
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