Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-01 @ 4:39 PM
Study NCT ID:
NCT01786850
Status:
AVAILABLE
Last Update Posted:
2014-06-18
First Post:
2013-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance-guided High-intensity Focused Ultrasound Treatment of Locally Advanced Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'lastUpdateSubmitDate': '2014-06-17', 'studyFirstSubmitDate': '2013-02-05', 'studyFirstSubmitQcDate': '2013-02-05', 'lastUpdatePostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Locally advanced Pancreatic Cancer', 'Noninvasive treatment', 'High Intensity focused ultrasound', 'Magnetic Resonance'], 'conditions': ['Pancreas', 'Cancer', 'Locally Advanced Pancreatic Cancer', 'Non-invasive Treatment']}, 'descriptionModule': {'briefSummary': 'Patients with unresectable pancreatic cancer in most of cases cannot benefit from percutaneous ablation modalities, due to high risk of procedure-related complications. Ultrasound-guided high intensity focused ultrasound (HIFU) ablation has been introduced as a feasible treatment option in these patients. However, in other anatomical regions US-guided HIFU has been replaced by the more accurate MR-guided focused ultrasound (MRgFUS) ablation, but the applicability of this latter technique to the treatment of pancreatic cancer is still unexplored. The aim of this study is to explore feasibility and clinical performance of MRgFUS ablation of unresectable pancreatic cancer. Two are the main end-points: Pain palliation and local tumor control.\n\nAs compared to conventional US-guided HIFU, MRgFUS could represent a more accurate, non-invasive ablation modality even for unresectable pancreatic cancer although, to date, no cases of pancreatic MRgFUS ablation have been reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* biopsy proven unresectable pancreatic adenocarcinoma;\n* unable or not willing to undergo chemo-radiation therapy\n* Celiac plexus alcoholization failed to control pain symptoms\n\nExclusion Criteria:\n\n* contraindication to MR or general anesthesia'}, 'identificationModule': {'nctId': 'NCT01786850', 'briefTitle': 'Magnetic Resonance-guided High-intensity Focused Ultrasound Treatment of Locally Advanced Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Magnetic Resonance-guided High-intensity Focused Ultrasound Treatment of Locally Advanced Pancreatic Cancer: Phase II Study for Pain Palliation and Local Tumor Control', 'orgStudyIdInfo': {'id': 'Pancreafus-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Magnetic Resonance-guided High-intensity Focused Ultrasound (MRgFUS)', 'type': 'PROCEDURE', 'description': 'High intensity focused ultrasound (HIFU) is a non-invasive ablation technique under ultrasound (US) guidance for the treatment of solid tumors. Differently from other ablations, HIFU induces tissue necrosis through short (10-30s) and relatively low grade (60-80 C°) thermal stimulations. Clinical applications of HIFU include uterine fibroids, prostate, hepatic and breast cancer. Selected patients with pancreatic cancer have been treated with US-guided HIFU for both pain control and tumor debulking. The development of a MR guidance for HIFU (MRgFUS) enabled to perform real-time monitoring and precise control of beam direction, temperature changes and deposited thermal dose beyond the capability of conventional US guidance. This system has been approved for the treatment of uterine fibroids and bone metastases in the United States and European Union. As compared to conventional US-guided HIFU, MRgFUS could represent a more accurate ablation modality for unresectable pancreatic cancer.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rome', 'status': 'AVAILABLE', 'country': 'Italy', 'contacts': [{'name': 'alessandro napoli', 'role': 'CONTACT'}], 'facility': 'Sapienza University of Rome, Policlinico Umberto I Hospital', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'alessandro napoli, MD, PhD', 'role': 'CONTACT', 'email': 'alessandro.napoli@uniroma1.it', 'phone': '+390649974540'}], 'overallOfficials': [{'name': 'alessandro napoli', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sapienza University of Rome, Policlinico Umberto I Hospital'}, {'name': 'carlo catalano', 'role': 'STUDY_CHAIR', 'affiliation': 'Sapienza University of Rome, Policlinico Umberto I Hospital'}, {'name': 'michele anzidei', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sapienza University of Rome, Policlinico Umberto I Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Alessandro Napoli', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}