Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2025-12-24 @ 1:16 PM
Study NCT ID:
NCT06855095
Status:
RECRUITING
Last Update Posted:
2025-03-03
First Post:
2023-10-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}], 'ancestors': [{'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013004', 'term': 'Somatostatin'}], 'ancestors': [{'id': 'D010905', 'term': 'Pituitary Hormone Release Inhibiting Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 39}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2023-10-25', 'studyFirstSubmitQcDate': '2025-02-26', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'HRQoL assessments', 'timeFrame': 'At baseline, on the day of PRRT administration, 3 weeks after PRRT'}], 'primaryOutcomes': [{'measure': 'Effect of continued LA-SSA use on the absorbed dose in tumor lesions during PRRT.', 'timeFrame': 'SPECT/CT after 4h, 24h, and 5-7 days post-injection'}], 'secondaryOutcomes': [{'measure': 'Effect of continued LA-SSA use on the absorbed dose in normal tissues during PRRT.', 'timeFrame': 'SPECT/CT after 4h, 24h, and 5-7 days post-injection and blood samples at 2h, 4h, 24h and 5-7 days post-injection'}, {'measure': 'Effect of continued LA-SSA use on the tumor-to-background ratio.', 'timeFrame': 'SPECT/CT after 4h, 24h, and 5-7 days post-injection'}, {'measure': 'Effect of continued LA-SSA use on population pharmacokinetic parameters of [177Lu]Lu-HA-DOTATATE.', 'timeFrame': 'Blood samples at 2h, 4h, 24h and 5-7 days post-injection'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peptide Receptor Radionuclide Therapy', 'PRRT', 'Lutetium', 'DOTATATE'], 'conditions': ['Neuroendocrine Tumors', 'Neuroendocrine Tumor Grade 1', 'Neuroendocrine Tumor Grade 2', 'Neuroendocrine Neoplasm']}, 'descriptionModule': {'briefSummary': 'According to current guidelines, patients have to withhalt long-acting somatostatin analogues (LA-SSA) for 4-6 weeks prior to every 177Lutetium-DOTATATE administration. The primary objective of the study is to investigate the effect of LA-SSA on the absorbed dose in tumor lesions during PRRT.', 'detailedDescription': 'The study population includes all patients aged over 18 with a neuroendocrine tumor grade I and II and a clinical indication for PRRT. Patients treated for at least three months with LA-SSA are randomized over two interventional arms: one arm where patients discontinue LA-SSA 4-6 weeks before the first PRRT treatment and one arm where patients continue LA-SSA treatment and receive the first PRRT administration within one week after the most recent LA-SSA injection. Patients in the control arm who have not been treated with LA-SSA in the last three months will start PRRT according to standard local protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Able to provide spoken and written informed consent for the trial;\n* Histopathological confirmed neuroendocrine tumor;\n* Fulfill the clinical criteria for PRRT;\n* At least one soft tissue lesion \\> 2 cm;\n* Aimed administered activity of 7400 MBq;\n* ECOG score (performance status) 0-2.\n\nExclusion Criteria:\n\n* Not possible to discontinue LA-SSA for 4-6 weeks;\n* Use of short-acting SSAs;\n* Pregnancy and lactating female patients;\n* Inability to comply to the study procedures;\n* Factors that might affect the biodistribution (for example, indication for furosemide directly after PRRT infusion, limited fluid intake, any renal catheters, etc.).'}, 'identificationModule': {'nctId': 'NCT06855095', 'acronym': 'ATSA', 'briefTitle': 'Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial', 'organization': {'class': 'OTHER', 'fullName': 'The Netherlands Cancer Institute'}, 'officialTitle': 'Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial', 'orgStudyIdInfo': {'id': 'N23PRR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'In this arm, patients without any LA-SSA treatment for at least 3 months prior to PRRT are included.'}, {'type': 'ACTIVE_COMPARATOR', 'label': '2A - LA-SSA injection 4-6 weeks before PRRT', 'description': 'In this arm, patients on LA-SSA treatment for at least 3 months prior to PRRT are included and will receive the last LA-SSA injection 4-6 weeks before PRRT.', 'interventionNames': ['Drug: Somatostatin analog']}, {'type': 'EXPERIMENTAL', 'label': '2B - LA-SSA injection 1-7 days before PRRT', 'description': 'In this arm, patients on LA-SSA treatment for at least 3 months prior to PRRT are included and will receive the last LA-SSA injection 4-6 weeks before PRRT.', 'interventionNames': ['Drug: Somatostatin analog']}], 'interventions': [{'name': 'Somatostatin analog', 'type': 'DRUG', 'description': 'Timing of LA-SSA injection prior to PRRT (either 4-6 weeks or 1-7 days).', 'armGroupLabels': ['2A - LA-SSA injection 4-6 weeks before PRRT', '2B - LA-SSA injection 1-7 days before PRRT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Stokkel', 'role': 'CONTACT', 'email': 'ev.schouten@nki.nl', 'phone': '+31205129111'}], 'facility': 'Antoni van Leeuwenhoek', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Netherlands Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Neuroendocrine Tumor Research Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}