Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-31 @ 9:49 AM
Study NCT ID:
NCT03699332
Status:
UNKNOWN
Last Update Posted:
2019-09-13
First Post:
2018-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-modality Imaging in Peritoneal Carcinomatosis of Colorectal Origin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010534', 'term': 'Peritoneal Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}], 'ancestors': [{'id': 'D000008', 'term': 'Abdominal Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 29}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-12', 'studyFirstSubmitDate': '2018-10-05', 'studyFirstSubmitQcDate': '2018-10-05', 'lastUpdatePostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fluorescent signal at time of surgery', 'timeFrame': 'During cytoreductive surgery', 'description': 'Can the tumor be identified by the fluorescent signal? Yes/No. Can the tumor be distinguished from normal tissue? Yes/No'}], 'secondaryOutcomes': [{'measure': 'Safety of dual-labeled antibody (labetuzumab) as assessed by the number of participants with grade 3 or 4 Adverse Events according to CTCAE v4.0', 'timeFrame': '4 weeks', 'description': 'Safety of dual-labeled antibody injection as assessed by the number of participants with grade 3 or 4 Adverse Events according to CTCAE v4.0'}, {'measure': 'Blood levels of the dual-labeled antibody', 'timeFrame': '60, 120 and 180 minutes after injection and 4 and 7 days after injection', 'description': 'Blood samples will be measured for radioactivity in a gamma counter at different timepoints after injection. This will be expressed as percentage injected dose per gram (%ID/g)'}, {'measure': 'Optimal dose of the dual-labeled antibody preparation', 'timeFrame': '4 weeks', 'description': 'Optimal dose of dual-labeled antibody for dual modality image guided surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['image guided surgery', 'CRS', 'HIPEC', 'Fluorescence', 'Antibodies, monoclonal'], 'conditions': ['Peritoneal Carcinomatosis', 'Colorectal Cancer', 'Carcinoma', 'Neoplasms', 'Gastrointestinal Cancer']}, 'referencesModule': {'references': [{'pmid': '35551444', 'type': 'DERIVED', 'citation': 'de Gooyer JM, Elekonawo FMK, Bremers AJA, Boerman OC, Aarntzen EHJG, de Reuver PR, Nagtegaal ID, Rijpkema M, de Wilt JHW. Multimodal CEA-targeted fluorescence and radioguided cytoreductive surgery for peritoneal metastases of colorectal origin. Nat Commun. 2022 May 12;13(1):2621. doi: 10.1038/s41467-022-29630-9.'}]}, 'descriptionModule': {'briefSummary': 'Intraoperative tumor localization and resection can be enhanced using intraoperative fluorescence imaging and radiodetection. Labetuzumab specifically recognizes CEA which is is expressed on \\> 95% of colorectal cancers.. Therefore Indium-111-DOTA-labetuzumab-IRDye800CW is a perfect dual-labeled antibody for dual-modality image-guided surgery in peritoneal carcinomatosis of colorectal cancer.', 'detailedDescription': 'In oncologic surgery complete tumor resection is important for treatment outcome and patient survival. When performing cytoreductive surgery (CRS) for peritoneal carcinomatosis of colorectal origin it can sometimes be difficult to distinguish tumor deposits from adhesions and scar tissue. Intraoperative tumor localization and resection can be enhanced using intraoperative imaging techniques (e.g. targeted radioguided or fluorescence guided surgery). A powerful synergy can be achieved by combining radiotracers (e.g. Indium-111) and optical tracers (e.g. IRDye 800CW) conjugated to an antibody against a tumor-associated antigen. Labetuzumab specifically recognises CEA which is expressed on \\> 95% of all colorectal cancers. Therefore Indium-111-DOTA-labetuzumab-IRDye800CW is a perfect dual-labeled antibody for dual-modality image-guided surgery in peritoneal carcinomatosis of colorectal origin. The concept has been shown in preclinical studies with mice and the investigators will translate this to the clinic.\n\nEligible patients with peritoneal carcinomatosis of colorectal origin scheduled for CRS + HIPEC will receive dual-labeled labetuzumab 6-7 days before surgery. At day 4 or 5 a SPECT/CT of the abdomen and thorax will be obtained. Cytoreductive surgery at day 7 will be extended with the use of a near-infrared fluorescence camera and a gamma probe.\n\nThe aim of this study is to assess the feasibility and safety of intraoperative dual-modality imaging with Indium-111-DOTA-labetuzumab-IRDye800CW in peritoneal carcinomatosis of colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of peritoneal carcinomatosis of colorectal origin\n* Scheduled for cytoreductive surgery and HIPEC.\n* Age over 18 years\n* Signed informed consent\n\nExclusion Criteria:\n\n* Any medical condition present that in the opinion of the investigator will affect patients clinicals status\n* Administration of a radionuclide within 10 physical half-lives prior to study enrollment\n* Pregnancy or lactation\n* Patients with very high (\\>500ng/ml serum CEA levels\n* Known CEA negative tumor'}, 'identificationModule': {'nctId': 'NCT03699332', 'acronym': 'MMIPC', 'briefTitle': 'Multi-modality Imaging in Peritoneal Carcinomatosis of Colorectal Origin', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'A Phase I/II Study to Evaluate the Safety and Feasibility of Multi-modality Imaging Using Indium-111-DOTA-labetuzumab-IRDye800CW in Patients With Peritoneal Carcinomatosis of Colorectal Origin', 'orgStudyIdInfo': {'id': 'NL57505.091.16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intraoperative multi-modality imaging', 'description': 'Patients receive a single intravenous dose of Indium-111-DOTA-Labetuzumab-IRDye800CW. At day 4 or 5 after antibody injection a SPECT/CT scan will be acquired. At day 6 or 7 standard of care cytoreductive surgery will be performed. This will be extended with the use of dual-modality imaging.', 'interventionNames': ['Drug: Indium-111-DOTA-Labetuzumab-IRDye800CW injection', 'Radiation: SPECT/CT scan', 'Procedure: CRS extended with dual-modality imaging']}], 'interventions': [{'name': 'Indium-111-DOTA-Labetuzumab-IRDye800CW injection', 'type': 'DRUG', 'description': 'Tracer injection', 'armGroupLabels': ['Intraoperative multi-modality imaging']}, {'name': 'SPECT/CT scan', 'type': 'RADIATION', 'description': 'Abdominal and thoracic SPECT/CT scan.', 'armGroupLabels': ['Intraoperative multi-modality imaging']}, {'name': 'CRS extended with dual-modality imaging', 'type': 'PROCEDURE', 'description': 'cytoreductive surgery will be performed extended with the use of dual-modality imaging.', 'armGroupLabels': ['Intraoperative multi-modality imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6525 GA', 'city': 'Nijmegen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Jan-Marie de Gooyer, MD', 'role': 'CONTACT'}], 'facility': 'Radboudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'centralContacts': [{'name': 'FMK Elekonawo, MD', 'role': 'CONTACT', 'email': 'Fortune.Elekonawo@radboudumc.nl', 'phone': '0031 24 3619097'}, {'name': 'JM de Gooyer, MD', 'role': 'CONTACT', 'email': 'Jan-Marie.Gooyer@radboudumc.nl', 'phone': '0031 24 3667244'}], 'overallOfficials': [{'name': 'JHW de Wilt, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dutch Cancer Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}