Peptide receptor radionuclide therapy in tumors with high expression of somatostatine receptors.

Peptide receptor radionuclide therapy in tumors with high expression of somatostatine receptors. - DOTATER1_26_15

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005546-63-IT

Enrollment

120

Registered

2021-01-28

Start date

2016-05-30

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer patients with high expression of somatostatin receptors (neurendocrine tumors, thyroid tumors, lung tumors, meningiomas). MedDRA version: 21.0 Level: PT Classification code 10052399 Term: Neuroendocrine tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: 177Lu-DOTA0-Tyr3-Octreotide Product Code: 177Lu-DOTATOC Pharmaceutical Form: Radiopharmaceutical precursor Product Name: 90Y-DOTA0-Tyr3-Octrotide Product Code: 90Y-DOTATOC Pharmaceutica

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients older than 18 patients with neuroendocrine tumors or with high expression of somatostatin receptors tumors (at any anatomical site e.g. brain cancer, colorectal cancer, differentiated thyroid carcinoma, lymphoma, breast cancer, melanoma, lung cancer, renal cancer, sarcoma, prostate cancer, liver cancer, thymic neoplasms) contrast Computed Tomography or Magnetic Resonance Imaging examination performed no longer than two months before the date of enrollment 68 Ga-SSA PET/CT examination performed no longer than two months before the date of enrollment and demonstrating the presence of lesions with high expression of somatostatin receptors blood values within the estabilished ranges ECOG performance status =2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: pregnancy ( positive pregnancy test on serum) refusal to stop breastfeeding inadequate contraception surgery, and/or chemotherapy, and/or radiation therapy (except for palliative radiation therapy) and /or biologics therapy performed in 4 four weeks before treatment partecipation to other research protocols bone marrow involvement >25% life expectancy <6 months inability to provide informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: To verify if there is a correlation between early response to therapy and 177Lu-SST-A uptake maximum percentage changes between basal evaluation and any other subsequent evaluation in target lesions in patients affected by NET.;Secondary Objective: To describe quantitatively the percentage change of 177Lu-SST-A uptake between basal evaluation and any other subsequent evaluation in target lesions in patients affected by NET. b. To verify if there is a correlation between the onset of hematological and kidney toxicity, and the percentage change of 177Lu-SST-A uptake between baseline and any other subsequent evaluation in target lesions in patients affected by NET. c. to verify if there are organ-specific differences in percentage change of 177Lu-SST-A uptake between baseline and any other subsequent evaluation in target lesions in patients affected by NET. To evaluate OS, PFS and ORR at 3 and 12 months ;Primary end point(s): Correlate early response to therapy and 177Lu-SST-A uptake maximum percentage changes between basal evaluation and any other subsequent evaluation in target lesions in patients affected by NET.;Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

Main Objective: To verify if there is a correlation between early response to therapy and 177Lu-SST-A uptake maximum percentage changes between basal evaluation and any other subsequent evaluation in target lesions in patients affected by NET.;Secondary Objective: To describe quantitatively the percentage change of 177Lu-SST-A uptake between basal evaluation and any other subsequent evaluation in target lesions in patients affected by NET. b. To verify if there is a correlation between the onset of hematological and kidney toxicity, and the percentage change of 177Lu-SST-A uptake between baseline and any other subsequent evaluation in target lesions in patients affected by NET. c. to verify if there are organ-specific differences in percentage change of 177Lu-SST-A uptake between baseline and any other subsequent evaluation in target lesions in patients affected by NET. To evaluate OS, PFS and ORR at 3 and 12 months ;Primary end point(s): Correlate early response to therapy and 177Lu-SST-A uptake maximum percentage changes between basal evaluation and any other subsequent evaluation in target lesions in patients affected by NET.;Timepoint(s) of evaluation of this end point: 3 months

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Secondary

Measure	Time frame
Secondary end point(s): The percentage change of 177Lu-SST-A uptake between basal evaluation and any other subsequent evaluation in target lesions in patients affected by NET.; Correlation between the onset of hematological and kidney toxicity, and the percentage change of 177Lu-SST-A uptake.; Organ-specific differences in percentage change of 177Lu-SST-A uptake.; OS, THE PFS AND ORR;Timepoint(s) of evaluation of this end point: At third and subsequent cycle of therapy; 3 and 12 months; At third and subsequent cycle of therapy; 3 and 12 months	—

Measure

Time frame

Secondary end point(s): The percentage change of 177Lu-SST-A uptake between basal evaluation and any other subsequent evaluation in target lesions in patients affected by NET.; Correlation between the onset of hematological and kidney toxicity, and the percentage change of 177Lu-SST-A uptake.; Organ-specific differences in percentage change of 177Lu-SST-A uptake.; OS, THE PFS AND ORR;Timepoint(s) of evaluation of this end point: At third and subsequent cycle of therapy; 3 and 12 months; At third and subsequent cycle of therapy; 3 and 12 months

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Countries

Italy

Contacts

Public ContactS.C. Medicina Nucleare

A.O. di Reggio Emilia Arcispedale S.Maria Nuova/IRCCS

annibale.versari@asmn.re.it0522296313

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026