Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-01-03 @ 11:12 PM
Study NCT ID:
NCT03265418
Status:
COMPLETED
Last Update Posted:
2019-09-04
First Post:
2017-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BioXmark, Rectal Feasibility Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], 'ancestors': [{'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': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-03', 'studyFirstSubmitDate': '2017-04-26', 'studyFirstSubmitQcDate': '2017-08-24', 'lastUpdatePostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positional stability of BioXmark liquid fiducial markers during the treatment course', 'timeFrame': 'will be determined through the course of radiotherapy, an average of 5 weeks', 'description': 'Positional stability / potential marker migration will be assessed by calculating marker pair distances.'}], 'secondaryOutcomes': [{'measure': 'Visibility/visual stability of BioXmark liquid fiducial markers during the treatment course', 'timeFrame': 'will be determined for the time interval between placement and the post-treatment MRI, an average of 12 weeks', 'description': 'Visual stability will be evaluated by scoring visibility of the markers on CT, CBCT, EPI and MRI (T1, T2 and diffusion weighted images) by 2 independent observers using a subjective scoring system: 0 = not visible, 1 = barely visible, 2 = clearly visible.'}, {'measure': 'Percentage of markers lost from injection to CT acquisition for RT planning', 'timeFrame': 'will be determined for the time interval between placement and pretreatment radiotherapy planning CT, an average of 1 week', 'description': '(1 - number of markers visible on the last CBCT (cone-beam computed tomography) during treatment / number of visible markers at pCT) \\* 100'}, {'measure': 'Percentage of markers lost from injection to CT acquisition for RT planning', 'timeFrame': 'will be determined for the time intervals through the course of radiotherapy, an average of 5 weeks', 'description': '(1 - number of markers visible on the last CBCT (cone-beam computed tomography) during treatment / number of visible markers at pCT) \\* 100'}, {'measure': 'Adverse events (AE) potentially associated with BioXmark', 'timeFrame': 'until rectal surgery, on average 11 weeks, or in case of omission of surgery, until 3 months after marker placement.', 'description': 'The safety of bioXmark liquid fiducials placement will be assessed by recording Adverse events (AE) potentially associated with BioXmark until rectal surgery, on average 11 weeks, or in case of omission of surgery, until 3 months after marker placement.'}, {'measure': 'Inter-observer variation in gross tumor volume (GTV) localization with and without markers', 'timeFrame': 'through the course of radiotherapy, an average of 5 weeks', 'description': 'The concordance index (CI) of gross tumor volume (GTV) localization between observers on kV CBCT will be determined. The CI is the ratio of the intersection and the union of the two volumes.'}, {'measure': 'Effect of BioXmark liquid fiducial markers on post-treatment MRI images', 'timeFrame': 'at the moment of the post-treatment MRI, on average 6-8 weeks after chemo-radiation', 'description': 'Potential BioXmark induced artefacts will be scored by 2 independent observers using a subjective scoring system:'}, {'measure': 'Potential BioXmark induced alterations in the surgical specimen', 'timeFrame': 'on average 10-12 weeks after chemo-radiation', 'description': "The surgical specimens will be evaluated for signs of marker-induced alterations.\n\nPotential BioXmark induced alteration in the surgical specimen will be scored by 2 independent observers using a subjective scoring system.In case the markers can't be located in the surgical specimen standard clinical evaluation of the specimen will take place. If the marker got lost during tissue processing potential inflammation/perforation will be scored as follows:A) 0 = no signs of extra inflammatory changes possibly related to the fiducials, 1 = limited extra inflammatory changes possibly related to the fiducials, 2 = severe extra inflammatory changes possibly related to the fiducials; B) 0 = no perforation of the rectal possibly related to fiducials, 1 = perforation of the rectal possibly related to the fiducials"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'To test the feasibility and accuracy of BioXmark fiducial markers for image guided radiotherapy (IGRT) based rectal tumor boosting in 20 patients referred for long course chemo-radiotherapy of the locally advanced rectal cancer.', 'detailedDescription': 'This study is a prospective non-randomized open label trial.\n\nA total of 20 patients who will undergo neo-adjuvant chemo-radiotherapy for rectal cancer will be included in this study upon informed consent.\n\nDuring an extra sigmoidoscopy after enema preparation, 4 liquid marker spots will be placed 1 cm from the tumor; two in the in the cranial and two in the caudal direction of the tumor (4 markers in total per patient).\n\nParticipants will undergo standard treatment for their rectal cancer.\n\nAs part of standard patient set-up directly before each radiotherapy treatment, kilovoltage (KV) cone-beam computed tomography (CBCT) will be acquired. Treatment positioning will be based on the regular clinical decision protocols for treatment of rectal cancer and not on the markers. During treatment potential fiducial movement will be assessed using an externally positioned ultra-sound probe (this probe will be positioned against the abdominal or perineal skin of the patients depending on de position of the tumor/fiducials in the rectum). Moreover, for patients in this study 2 orthogonal kV images will be made immediately after each radiation using the electronic portal imaging (EPI) device.\n\nAs part of standard clinical practice an Magnetic resonance imaging (MRI) of the rectum will be made for response evaluation 6-8 weeks after the end of neo-adjuvant chemo-radiotherapy.\n\nAs part of standard clinical practice patients whose tumor has not responded completely will be operated on 8-12 weeks after the end of neoadjuvant chemo-radiotherapy. Patients with a complete response will be follow-upped according to the "wait-and-see" protocol.\n\nCone-beam CT and MR images which are obtained as routine practice during treatment of the participants will be compared with images of 20 non-participating patients treated at our institute in the same period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histological or cytological proven adenocarcinoma of the rectum, treated with long course external beam radiotherapy\n* Age \\> 18 years\n* Have given written informed consent before patient registration\n\nExclusion Criteria:\n\n* Patients using anticoagulants: platelet aggregation inhibitors or coumarines\n* Iodine allergy'}, 'identificationModule': {'nctId': 'NCT03265418', 'briefTitle': 'BioXmark, Rectal Feasibility Trial', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht Radiation Oncology'}, 'officialTitle': 'BioXmark Liquid Fiducials to Enable Radiotherapy Tumor Boosting in Rectal Cancer, a Feasibility Trial', 'orgStudyIdInfo': {'id': 'W 16 09 00091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BioXmark liquid fiducial markers', 'description': 'Placement of 4 BioXmark liquid fiducial markers, standard treatment (chemo-radiotherapy followed by surgery or wait-and-see) with extra imaging to evaluate the behaviour of the markers before, during and after the radiotherapy', 'interventionNames': ['Device: BioXmark liquid fiducial markers', 'Other: Imaging', 'Procedure: surgery or wait-and-see']}], 'interventions': [{'name': 'BioXmark liquid fiducial markers', 'type': 'DEVICE', 'description': 'Before the start of the treatment planning during an extra sigmoidoscopy after enema preparation, 4 liquid marker spots will be placed 1 cm from the tumor; two in the in the cranial and two in the caudal direction of the tumor (4 markers in total per patient).', 'armGroupLabels': ['BioXmark liquid fiducial markers']}, {'name': 'Imaging', 'type': 'OTHER', 'description': 'As part of standard patient set-up directly before each radiotherapy treatment, kV cone-beam CTs will be acquired. Treatment positioning will be based on the regular clinical decision protocols for treatment of rectal cancer and not on the markers. During treatment potential fiducial movement will be assessed using an externally positioned ultra-sound probe, positioned against the abdominal or perineal skin of the patients depending on de position of the tumor/fiducials in the rectum. For patients in this study 2 orthogonal kV images will be made immediately after each radiation using the electronic portal imaging (EPI) device.\n\nAs part of standard clinical practice an MR of the rectum will be made for response evaluation 6-8 weeks after the end of neo-adjuvant chemo-radiotherapy.', 'armGroupLabels': ['BioXmark liquid fiducial markers']}, {'name': 'surgery or wait-and-see', 'type': 'PROCEDURE', 'description': 'As part of standard clinical practice patients whose tumor has not responded completely will be operated on 8-12 weeks after the end of neoadjuvant chemo-radiotherapy. Patients with a complete response will be follow-upped according to the "wait-and-see" protocol.', 'armGroupLabels': ['BioXmark liquid fiducial markers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6202 NA', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'MAASTRO Clinic', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Maaike Berbée, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastro Clinic, The Netherlands'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht Radiation Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}