Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-01-01 @ 6:24 AM
Study NCT ID:
NCT00997633
Status:
COMPLETED
Last Update Posted:
2009-10-19
First Post:
2009-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-photon Emission Computed Tomography (SPECT) to Predict Peritoneal Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010534', 'term': 'Peritoneal Neoplasms'}], 'ancestors': [{'id': 'D000008', 'term': 'Abdominal Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1991-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-16', 'studyFirstSubmitDate': '2009-10-16', 'studyFirstSubmitQcDate': '2009-10-16', 'lastUpdatePostDateStruct': {'date': '2009-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detected volume measured by SPECT compared to the number of subsequent sequential postoperative intraperitoneal chemotherapy courses'}], 'secondaryOutcomes': [{'measure': 'The relationship between SPECT, feasibility of SPIC (intraperitoneal chemotherapy), and clinical variables'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intraperitoneal volume', 'peritoneal carcinomatosis', 'cytoreductive surgery', 'SPECT', 'intraperitoneal chemotherapy'], 'conditions': ['Peritoneal Carcinomatosis']}, 'descriptionModule': {'briefSummary': 'SPECT was performed in 51 patients after cytoreductive surgery in combination with intraperitoneal chemotherapy. The detected volume was compared to the number of subsequent sequential postoperative intraperitoneal chemotherapy courses that could be performed without further surgical intervention. SPECT data was found to predict feasibility of sequential postoperative intraperitoneal chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had undergone cytoreductive surgery and intraperitoneal chemotherapy (SPIC) at the Dept of Surgical Sciences, Uppsala University Hospital in the time period between May 1991 and August 2004.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cytoreductive surgery and intraperitoneal chemotherapy\n* Single-Photon Emission Computed Tomography (SPECT) before the second course of treatment'}, 'identificationModule': {'nctId': 'NCT00997633', 'briefTitle': 'Single-photon Emission Computed Tomography (SPECT) to Predict Peritoneal Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Single-photon Emission Computed Tomography for Prediction of Treatment Results in Sequential Intraperitoneal Chemotherapy at Peritoneal Carcinomatosis', 'orgStudyIdInfo': {'id': 'SPECT IK1991:5'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Peritoneal carcinomatosis', 'description': 'Patients undergoing cytoreductive surgery and intraperitoneal chemotherapy treatment'}]}, 'contactsLocationsModule': {'locations': [{'city': 'S-751 85 Uppsala', 'country': 'Sweden', 'facility': 'Dept of Surgical Sciences, Section of Surgery'}], 'overallOfficials': [{'name': 'Haile Mahteme, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Surgical Sciences, University Hospital, Uppsala, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Haile Mahteme, MD PhD', 'oldOrganization': 'Dept of Surgical Sciences, Section of Surgery, Uppsala University, Sweden'}}}}