Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
Study NCT ID:
NCT06755359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2024-12-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alpha Radiation Emitters Device (DaRT) for the Treatment of Locally Advanced Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2024-12-19', 'studyFirstSubmitQcDate': '2024-12-31', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety - Serious adverse events', 'timeFrame': 'from Day 0 , up to 12 months', 'description': 'Safety will be determined according to the overall incidence of device related SAEs with severity graded according to CTCAE v5.0 criteria'}], 'secondaryOutcomes': [{'measure': 'Efficacy - tumor response', 'timeFrame': 'Day 0 , up to 12 months', 'description': 'to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to Objective tumor response rate according to RECIST 1.1'}, {'measure': 'Efficacy - overall survival', 'timeFrame': 'Day 0 , up to 12 months', 'description': 'to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to Overall survival'}, {'measure': 'Efficacy - Progression-free survival', 'timeFrame': 'Day 0 , up to 12 months', 'description': 'to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to - Progression-free survival'}, {'measure': 'Efficacy - Percentage of R0/R1 resected patients', 'timeFrame': 'Day 0 , up to 12 months', 'description': 'to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to Percentage of R0/R1 resected patients'}, {'measure': 'Efficacy - percentage of patients with tumors that became surgically respectable after DaRT treatment', 'timeFrame': 'Day 0 , up to 12 months', 'description': 'to evaluate the efficacy of the Alpha DaRT sources in advanced pancreatic cancer patients with respect according to percentage of patients with tumors that became surgically respectable after DaRT treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alpha radiation', 'pancreatic cancer'], 'conditions': ['Pancreatic Cancer', 'Locally Advanced Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'A unique approach for cancer treatment including radioactive sources named Alpha DaRT sources: Ra - 224 coated onto stainless steel tubes inserted into the tumor for the treatment of Locally Advanced Pancreatic Cancer .', 'detailedDescription': 'This study will be a prospective, interventional, open label, single arm, multiple center study.\n\nPatients who have been previously treated with 8 - 12 cycles of mFOLFIRINOX will undergo DaRT insertion, with the goal of making their tumor resectable. Three (3) days after DaRT insertion, patients will begin taking Capecitabine for 2 months. Every 2 months after DaRT insertion, the patient will be assessed to determine if their tumor is surgically resectable, if they should continue with therapy, or if they should pause therapy. The trial will end 12 months after DaRT insertion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically and/or cytologically proven locally advanced pancreatic adenocarcinoma\n* Target lesion is technically amenable for Alpha DaRT sources implantation.\n* Measurable lesion per RECIST (version 1.1) criteria\n* Stable disease or tumor response per RECIST (version 1.1) criteria compared to before initiation of mFOLFIRINOX\n* Lesion size ≤ 5 cm in the longest diameter\n* Interstitial radiation indication validated by a multidisciplinary team which includes an oncologist, a radiation oncologist, radiologist, gastroenterologist and a surgeon specialized in pancreatic oncology in the case that a surgical emergency occurs during the procedure\n* Patients have received 8 - 12 cycles of mFOLFIRINOX\n* ECOG Performance Status Scale 0 - 1\n* Life expectancy is more than 6 months\n* WBC ≥ 3500/µl, granulocyte ≥ 1500/µl\n* Platelet count ≥60,000/µl\n* Creatinine ≤1.9 mg/dL\n* AST and ALT ≤ 2.5 X upper limit of normal (ULN)\n* INR \\< 1.4 for patients not on Warfarin\n* Age ≥18 years old\n* Subjects are willing and able to sign an informed consent form\n* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after initiation of Alpha DaRT therapy\n* Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after DaRT insertion.\n\nExclusion Criteria:\n\n* Concomitant immunotherapy within the past 4 weeks.\n* Patients with metastatic disease\n* Borderline unresectable pancreatic cancer, and/or cases fit for surgical exploration unless patient refuses surgery.\n* Known hypersensitivity to any of the components of the treatment.\n* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.\n* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n* Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, low risk prostate cancer, or in situ cervical cancer.\n* Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.\n* Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.\n* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.\n* High probability of protocol non-compliance (in opinion of investigator).\n* Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.'}, 'identificationModule': {'nctId': 'NCT06755359', 'briefTitle': 'Alpha Radiation Emitters Device (DaRT) for the Treatment of Locally Advanced Pancreatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alpha Tau Medical LTD.'}, 'officialTitle': 'A Safety Study of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'CTP-PANC-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DaRT Seeds', 'description': 'Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds', 'interventionNames': ['Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)']}], 'interventions': [{'name': 'Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)', 'type': 'DEVICE', 'description': 'Radioactive sources named Alpha DaRT sources: Ra - 224 coated onto titanium tubes inserted into the tumor.', 'armGroupLabels': ['DaRT Seeds']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'contacts': [{'name': 'Brieuc Bernard', 'role': 'CONTACT', 'email': 'brieuc.bernard@chu-bordeaux.fr'}], 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Bordeaux', 'country': 'France', 'contacts': [{'name': 'Aurore Salvaudon', 'role': 'CONTACT', 'email': 'aurore.salvaudon@chu-bordeaux.fr'}], 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'contacts': [{'name': 'Veronique DEDIEU', 'role': 'CONTACT', 'email': 'veronique.dedieu@clermont.unicancer.fr'}], 'facility': 'Centre Jean PERRIN - Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Dijon', 'country': 'France', 'contacts': [{'name': 'Lydie HOUOT', 'role': 'CONTACT', 'email': 'lhouot@cgfl.fr'}], 'facility': 'Centre Georges François Leclerc Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Dijon', 'country': 'France', 'contacts': [{'name': 'Aurelie PETITFILS', 'role': 'CONTACT', 'email': 'apetitfils@cgfl.fr'}], 'facility': 'Centre Georges François Leclerc Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Dijon', 'country': 'France', 'contacts': [{'name': 'Leone AUBIGNAC', 'role': 'CONTACT', 'email': 'laubignac@cgfl.fr'}], 'facility': 'Centre Georges François Leclerc Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Grenoble', 'country': 'France', 'contacts': [{'name': 'Jean-Yves Giraud', 'role': 'CONTACT', 'email': 'jygiraud@chu-grenoble.fr'}], 'facility': 'CHU Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Mustapha Khodri', 'role': 'CONTACT', 'email': 'khodri1@yahoo.fr'}], 'facility': 'Hôpital Privé Mermoz - Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'contacts': [{'name': 'Julien Darreon', 'role': 'CONTACT', 'email': 'darreonj@ipc.unicancer.fr'}], 'facility': 'Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Poitiers', 'country': 'France', 'contacts': [{'name': 'Aurelie SORS', 'role': 'CONTACT', 'email': 'lhouot@cgfl.fr'}], 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Poitiers', 'country': 'France', 'contacts': [{'name': 'Eric DAVID', 'role': 'CONTACT', 'email': 'eric.david@chu-poitiers.fr'}], 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Villejuif', 'country': 'France', 'contacts': [{'name': 'Pauline Maury', 'role': 'CONTACT', 'email': 'pauline.maury@gustaveroussy.fr', 'phone': '+33674218420'}], 'facility': 'Gustave Roussy Institute', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'Liron Dimnik', 'role': 'CONTACT', 'email': 'LironD@alphatau.com', 'phone': '972-54-2688602'}, {'name': 'Aviya Hoida', 'role': 'CONTACT', 'email': 'aviyah@alphatau.com', 'phone': '972-54-7869466'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alpha Tau Medical LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}