Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-25 @ 2:59 PM
Study NCT ID:
NCT07213050
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2025-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Percutaneous Thermal Ablation (Radiofrequency and Microwave) in the Treatment of Anterior Abdominal Wall Masses: An Evaluation of Efficacy and Safety.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008872', 'term': 'Microwaves'}], 'ancestors': [{'id': 'D011846', 'term': 'Radio Waves'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2025-10-01', 'studyFirstSubmitQcDate': '2025-10-01', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical Success', 'timeFrame': 'baseline', 'description': 'complete coverage of the target lesion by the ablation zone with an adequate margin on the immediate post-procedure CT scan'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anterior Abdominal Wall Masses']}, 'descriptionModule': {'briefSummary': 'The anterior abdominal wall is a common site for metastatic deposits (e.g., from colorectal, ovarian, or hepatocellular carcinoma), desmoid tumors (aggressive fibromatosis), and endometriomas. Surgical resection has been the traditional standard of care. However, surgery in this region can be complex due to the proximity of vital structures, the need for large tissue resection, and high recurrence rates. Furthermore, patients often present with significant comorbidities or have recurrent disease after previous surgeries, making them poor surgical candidates While established in organs like the liver and lungs, their application specifically for abdominal wall lesions is a growing and evidence-supported field that warrants further systematic study to standardize protocols and confirm long-term outcomes.\n\nPercutaneous thermal ablation, including microwave ablation (MWA) and radiofrequency ablation (RFA), is an increasingly used minimally invasive treatment for anterior abdominal wall lesions such as metastatic tumors and benign lesions like abdominal wall endometriosis. These techniques deliver thermal energy through percutaneous probes to induce coagulative necrosis, offering an effective alternative to surgery with lower morbidity and shorter recovery times.\n\nRFA uses high-frequency electrical currents to generate heat and ablate tumors. It is well established for treating abdominal wall recurrences, particularly from colorectal cancer, with effective local control and symptom relief.\n\nUltrasound-guided MWA has demonstrated excellent safety and efficacy for abdominal wall lesions. Studies report significant lesion volume reduction, pain relief, and low complication rates in patients with abdominal wall endometriosis and metastases. The ability to visualize the ablation zone in real-time with ultrasound enhances precision and protects adjacent structures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Patients with biopsy-proven metastases to the anterior abdominal wall (e.g., from colorectal, breast, ovarian cancer). 2. Patients with biopsy-proven desmoid tumors (aggressive fibromatosis). 3. Patients with symptomatic abdominal wall endometriomas. 4. Lesion size ≤ 5 cm in greatest diameter. 5. Patients deemed unfit for surgery due to comorbidities, or who refuse surgical intervention. 6. Platelet count \\> 50,000/µL and INR \\< 1.5.\n\nExclusion Criteria:\n\n* 1\\. Uncorrectable coagulopathy. 2. Lesion size \\> 5 cm. 3. Unlimited diffuse peritoneal carcinomatosis. 4. Skin or bowel wall involvement with no safe percutaneous pathway for ablation (as determined on pre-procedural CT) 5. Life expectancy \\< 3 months.'}, 'identificationModule': {'nctId': 'NCT07213050', 'briefTitle': 'Percutaneous Thermal Ablation (Radiofrequency and Microwave) in the Treatment of Anterior Abdominal Wall Masses: An Evaluation of Efficacy and Safety.', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Percutaneous Thermal Ablation (Radiofrequency and Microwave) in the Treatment of Anterior Abdominal Wall Masses: An Evaluation of Efficacy and Safety.', 'orgStudyIdInfo': {'id': 'Percutaneous Thermal Ablation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'study group', 'description': 'Patients with biopsy-proven metastases to the anterior abdominal wall (e.g.,from colorectal, breast, ovarian cancer)', 'interventionNames': ['Procedure: Radiofrequency', 'Procedure: Microwave']}], 'interventions': [{'name': 'Radiofrequency', 'type': 'PROCEDURE', 'description': 'achieve a target temperature of 90-110°C for 4-12 minutes, ensuring an ablative margin of at least 0.5-1.0 cm around the tumor.', 'armGroupLabels': ['study group']}, {'name': 'Microwave', 'type': 'PROCEDURE', 'description': 'Antennas will be placed under imaging guidance, and ablation will be performed for 5-10 minutes per antenna activation to achieve the desired margin.', 'armGroupLabels': ['study group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'residant doctor at Assiut university hospital', 'investigatorFullName': 'MOHAMED ALI IBRAHIM ABOLOYOUN SAYED', 'investigatorAffiliation': 'Assiut University'}}}}