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Last Updated: June 27, 2022

CLINICAL TRIALS PROFILE FOR LUTETIUM DOTATATE LU-177


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All Clinical Trials for Lutetium Dotatate Lu-177

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02358356 ↗ Capecitabine ON Temozolomide Radionuclide Therapy Octreotate Lutetium-177 NeuroEndocrine Tumours Study Unknown status Australasian Gastro-Intestinal Trials Group Phase 2 2015-11-01 Two parallel phase II randomized open label trials of Lutetium-177 Octreotate (177Lu-Octreotate) peptide receptor radionuclide therapy (PRRT) and capecitabine (CAP)/temozolomide (TEM) chemotherapy (chemo): (i) versus CAPTEM alone in the treatment of low to intermediate grade pancreatic neuroendocrine tumours (pNETs); (ii) versus PRRT alone in the treatment of low to intermediate grade mid gut neuroendocrine tumours (mNETs).
NCT02743741 ↗ Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors Recruiting Canadian Molecular Imaging Probe Consortium N/A 2016-07-01 This is a prospective single arm, multicenter study will evaluate the efficacy and safety of Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Patient who has progressed with neuroendocrine tumor will be evaluated by the tumor board first and eligible patients will undergo diagnostic Ga 68 PET scan. Patients who showed Somatostatin will undergo 4 cycles of Lu-DOTATATE treatment. Dose adjustment for Cycle 2-4 will be made based on individualized dosimetry, as well as creatinine clearance and hematological parameters. Patients will be evaluated progression free survival at 12 months from last dose. Patients who are negative for somatostatin will not receive 68Ga-DOTATATE treatment but will be followed until progression and acts as control group.
NCT02743741 ↗ Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors Recruiting Cancer Care Ontario N/A 2016-07-01 This is a prospective single arm, multicenter study will evaluate the efficacy and safety of Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Patient who has progressed with neuroendocrine tumor will be evaluated by the tumor board first and eligible patients will undergo diagnostic Ga 68 PET scan. Patients who showed Somatostatin will undergo 4 cycles of Lu-DOTATATE treatment. Dose adjustment for Cycle 2-4 will be made based on individualized dosimetry, as well as creatinine clearance and hematological parameters. Patients will be evaluated progression free survival at 12 months from last dose. Patients who are negative for somatostatin will not receive 68Ga-DOTATATE treatment but will be followed until progression and acts as control group.
NCT02743741 ↗ Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors Recruiting Ozmosis Research Inc. N/A 2016-07-01 This is a prospective single arm, multicenter study will evaluate the efficacy and safety of Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Patient who has progressed with neuroendocrine tumor will be evaluated by the tumor board first and eligible patients will undergo diagnostic Ga 68 PET scan. Patients who showed Somatostatin will undergo 4 cycles of Lu-DOTATATE treatment. Dose adjustment for Cycle 2-4 will be made based on individualized dosimetry, as well as creatinine clearance and hematological parameters. Patients will be evaluated progression free survival at 12 months from last dose. Patients who are negative for somatostatin will not receive 68Ga-DOTATATE treatment but will be followed until progression and acts as control group.
NCT02743741 ↗ Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors Recruiting University Health Network, Toronto N/A 2016-07-01 This is a prospective single arm, multicenter study will evaluate the efficacy and safety of Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Patient who has progressed with neuroendocrine tumor will be evaluated by the tumor board first and eligible patients will undergo diagnostic Ga 68 PET scan. Patients who showed Somatostatin will undergo 4 cycles of Lu-DOTATATE treatment. Dose adjustment for Cycle 2-4 will be made based on individualized dosimetry, as well as creatinine clearance and hematological parameters. Patients will be evaluated progression free survival at 12 months from last dose. Patients who are negative for somatostatin will not receive 68Ga-DOTATATE treatment but will be followed until progression and acts as control group.
NCT03590119 ↗ Intra-arterial Lutetium-177-dotatate for Treatment of Patients With Neuro-endocrine Tumor Liver Metastases Recruiting Marnix Lam Phase 2/Phase 3 2018-08-01 The objective is to investigate the impact of intra-arterial administration of 177Lu-dotatate on the intrahepatic biodistribution in patients with NET liver metastases. Our primary objective is to evaluate if there is a difference in post-treatment tumor-to-non-tumor (T/N) activity concentration ratio on SPECT/CT between the intra-arterial treated liver lobe and the intravenous treated liver lobe.
NCT04082520 ↗ Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy Recruiting National Cancer Institute (NCI) Phase 2 2020-03-10 This phase II trial studies how well lutathera works in treating patients with meningioma that cannot be treated with surgery (inoperable) and is growing, spreading, or getting worse (progressive) after external beam radiation therapy. Lutathera is a radioactive drug administered in the vein that is designed to target and kill cancer cells. The goal of this study is to determine whether this drug is safe and effective in treating meningiomas that progress after radiation treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lutetium Dotatate Lu-177

Condition Name

Condition Name for Lutetium Dotatate Lu-177
Intervention Trials
Neuroendocrine Tumors 4
High Grade Glioma 1
Recurrent Malignant Glioma 1
Meningioma 1
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Condition MeSH

Condition MeSH for Lutetium Dotatate Lu-177
Intervention Trials
Neuroendocrine Tumors 9
Neoplasms 4
Carcinoid Tumor 3
Carcinoma 2
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Clinical Trial Locations for Lutetium Dotatate Lu-177

Trials by Country

Trials by Country for Lutetium Dotatate Lu-177
Location Trials
United States 26
Australia 4
Canada 1
Netherlands 1
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Trials by US State

Trials by US State for Lutetium Dotatate Lu-177
Location Trials
Massachusetts 3
Kentucky 3
Pennsylvania 2
Ohio 2
Illinois 2
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Clinical Trial Progress for Lutetium Dotatate Lu-177

Clinical Trial Phase

Clinical Trial Phase for Lutetium Dotatate Lu-177
Clinical Trial Phase Trials
Phase 2/Phase 3 1
Phase 2 7
Phase 1/Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Lutetium Dotatate Lu-177
Clinical Trial Phase Trials
Recruiting 7
Not yet recruiting 4
Unknown status 1
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Clinical Trial Sponsors for Lutetium Dotatate Lu-177

Sponsor Name

Sponsor Name for Lutetium Dotatate Lu-177
Sponsor Trials
National Cancer Institute (NCI) 7
Marnix Lam 1
Progenics Pharmaceuticals, Inc. 1
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Sponsor Type

Sponsor Type for Lutetium Dotatate Lu-177
Sponsor Trials
Other 14
NIH 8
Industry 5
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