Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-01-04 @ 6:12 PM
Study NCT ID:
NCT03647657
Status:
COMPLETED
Last Update Posted:
2022-02-10
First Post:
2018-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
177Lu-PP-F11N in Combination With Sacubitril for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536914', 'term': 'Thyroid cancer, medullary'}, {'id': 'D018276', 'term': 'Carcinoma, Medullary'}], 'ancestors': [{'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'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': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549068', 'term': 'sacubitril and valsartan sodium hydrate drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Group 1 patients will receive first 177Lu-PP-F11N alone, second 177Lu-PP-F11N in combination with Sacuitril. Group 2 patients will first receive 177Lu-PP-F11N in combination with Sacuitril, second 177Lu-PP-F11N alone. Affiliation of patients to Groups 1 and 2 will be randomised.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-09', 'studyFirstSubmitDate': '2018-08-20', 'studyFirstSubmitQcDate': '2018-08-22', 'lastUpdatePostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Chromogranin A', 'timeFrame': 'Measurement up to 72 hours after the first injection of 177Lu-PP-F11N', 'description': 'Chromogranin A blood values will be compared to the radiation doses of the stomach.'}, {'measure': '68Ga-DOTATOC PET/CT', 'timeFrame': 'Measurement up to 72 hours after each injection of 177Lu-PP-F11N', 'description': 'Comparison of tumor imaging by 68Ga-DOTATOC PET/CT and 177Lu-PP-F11N SPECT/CT'}], 'primaryOutcomes': [{'measure': 'Tumor radiation doses', 'timeFrame': 'Measurement up to 72 hours after each injection of 177Lu-PP-F11N', 'description': 'Evaluation of the radiation doses in tumor tissue from MTC after injection of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto)'}], 'secondaryOutcomes': [{'measure': 'Kidney radiation doses', 'timeFrame': 'Measurement up to 72 hours after each injection of 177Lu-PP-F11N', 'description': 'Evaluation of the radiation doses in the kidneys and the tumor-to-kidney dose ratios after injection of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto)'}, {'measure': 'Organ radiation doses', 'timeFrame': 'Measurement up to 72 hours after each injection of 177Lu-PP-F11N', 'description': 'Evaluation of the radiation doses in other organs and the appropriate organ-to-kidney dose ratios after injection of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto)'}, {'measure': 'In-vivo stability', 'timeFrame': 'Blood samples for measurement 5 and 30 minutes post injection of 177Lu-PP-F11N', 'description': 'Measurement (HPLC) of the in-vivo stability of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto).'}, {'measure': 'Autoradiography', 'timeFrame': 'Through study completion, up to 18 months', 'description': 'In case of surgery with available tumor tissue samples, imaging results will be compared with autoradiographic analysis of somatostatine- and CCK2-receptor expression in tumor tissue.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Calcitonin', 'Medullary thyroid carcinoma', 'Peptide receptor radionuclide therapy', 'Gastrin', 'Cholecystokinin-2 receptor'], 'conditions': ['Thyroid Cancer, Medullary']}, 'referencesModule': {'references': [{'pmid': '30002107', 'type': 'RESULT', 'citation': 'Sauter AW, Mansi R, Hassiepen U, Muller L, Panigada T, Wiehr S, Wild AM, Geistlich S, Behe M, Rottenburger C, Wild D, Fani M. Targeting of the Cholecystokinin-2 Receptor with the Minigastrin Analog 177Lu-DOTA-PP-F11N: Does the Use of Protease Inhibitors Further Improve In Vivo Distribution? J Nucl Med. 2019 Mar;60(3):393-399. doi: 10.2967/jnumed.118.207845. Epub 2018 Jul 12.'}, {'pmid': '38581480', 'type': 'DERIVED', 'citation': 'Rottenburger C, Hentschel M, Furstner M, McDougall L, Kottoros D, Kaul F, Mansi R, Fani M, Vija AH, Schibli R, Geistlich S, Behe M, Christ ER, Wild D. In-vivo inhibition of neutral endopeptidase 1 results in higher absorbed tumor doses of [177Lu]Lu-PP-F11N in humans: the lumed phase 0b study. EJNMMI Res. 2024 Apr 6;14(1):37. doi: 10.1186/s13550-024-01101-w.'}], 'seeAlsoLinks': [{'url': 'https://www.unispital-basel.ch/en', 'label': 'University Hospital Basel Homepage'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on more than 90 % of medullary thyroid carcinomas.', 'detailedDescription': 'A phase 0 study (Lumed study part A) was already performed, showing low toxicity of 177Lu-PP-F11N and tumor uptake in all patients. Co-injection of Physiogel (Gelofusin) showed insignificant reduction of kidney uptake and can therefore be omitted for a radionuclide therapy with 177Lu-PP-F11N. In this study, the effect of the NEP-1 inhibitor Sacuitril on the in-vivo stability of 177Lu-PP-F11N and the uptake, respectively radiation doses in MTC metastases and organs will be evaluated, using a cross-over design already used for the Lumed part A study. Each patient will receive two injections of 177Lu-PP-F11N, with and without additional medication with Sacuitril Imaging findings, acquired by SPECT/CT, will be compared to imaging with 68Ga-DOTATOC positron emission tomography (PET)/CT. The inclusion of 8 patients is planned.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced MTC with elevated levels of calcitonin (\\> 100 pg/ml) and/or calcitonin-doubling time \\< 24 months before or after total thyroidectomy\n* 68Ga-DOTATOC PET/CT not older than 12 weeks\n* Age \\> 18 years\n* Informed consent\n\nExclusion Criteria:\n\n* Medication with Vandetanib 3 weeks before the study and during the study\n* Renal failure (calculated glomerular filtration rate (GFR) \\< 60 ml/min per 1.73 m2 body surface).\n* Bone marrow failure (thrombocytes \\< 70 000/μl, leucocytes \\< 2 500/μl, hemoglobin \\< 8 g/dl).\n* Pregnancy and breast feeding\n* Known, serious side reaction in the case of a former application of pentagastrin\n* Active, second malignancy oder remission after second malignancy \\< 5 years\n* Age over 64 years\n* Systolic bood pressure \\< 112 mmHg at the time of screening\n* Simultaneous medication with angiotensin converting enzyme (ACE)-inhibitors, or withdrawal for less than 36 h prior to the medication with Entresto or simultaneous medication with AT-II-receptor blockers\n* Known intolerance to Sacubitril or Valsartan\n* Known angioedema in anamnesis in the context of a medication with an ACE-inhibitor or an AT-II-receptor blocker'}, 'identificationModule': {'nctId': 'NCT03647657', 'briefTitle': '177Lu-PP-F11N in Combination With Sacubitril for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': '177Lu-PP-F11N in Combination With Sacubitril for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer (Lumed Phase 0/B)', 'orgStudyIdInfo': {'id': '2018-00972'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Entresto second', 'description': 'First intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N without and second injection with additional medication of Sacuitril (100 mg Entresto)(crossover)', 'interventionNames': ['Drug: 177Lu-PP-F11N', 'Drug: Sacuitril']}, {'type': 'EXPERIMENTAL', 'label': 'Entresto first', 'description': 'First intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N with and second injection without additional medication of Sacuitril (100 mg Entresto)(crossover)', 'interventionNames': ['Drug: 177Lu-PP-F11N', 'Drug: Sacuitril']}], 'interventions': [{'name': '177Lu-PP-F11N', 'type': 'DRUG', 'otherNames': ['Radiopharmakon'], 'description': 'Intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N with and without co-medication with Sacuitril (100 mg Entresto) in each patient', 'armGroupLabels': ['Entresto first', 'Entresto second']}, {'name': 'Sacuitril', 'type': 'DRUG', 'otherNames': ['Entresto'], 'description': 'Medication with Sacuitril (100 mg Entresto) additional to the injection of 177Lu-PP-F11N', 'armGroupLabels': ['Entresto first', 'Entresto second']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel, Clinic for radiology and nuclear medicine', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Christof Rottenburger, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Basel, Clinic for radiology and nuclear medicine'}, {'name': 'Damian Wild, PhD Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital Basel, Clinic for radiology and nuclear medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Krebsforschung Schweiz, Bern, Switzerland', 'class': 'OTHER'}, {'name': 'Center for Proton Therapy, Paul Scherrer Institute, Villigen,Switzerland', 'class': 'OTHER'}, {'name': 'University Hospital, Zürich', 'class': 'OTHER'}, {'name': 'University Hospital Freiburg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}