Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-04-11 @ 5:58 PM
Study NCT ID:
NCT01902667
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2013-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Imaging in Retroperitoneal Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2013-07-09', 'studyFirstSubmitQcDate': '2013-07-16', 'lastUpdatePostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlation of imaging features with histopathological assessment of tumour size, local staging, cellularity, necrosis and viable tumour.', 'timeFrame': '2 months', 'description': "Correlation between the ADC (and D) and %ki 67 uptake, % necrosis, %fat content, % of viable tumour, % hyalinization/fibrosis, % dedifferentiated component, cellularity and stroma morphology will be assessed using the Pearson's correlation coefficient or the Spearman's (whichever is appropriate)."}], 'primaryOutcomes': [{'measure': 'Prediction, by MRI, of early response to radiotherapy prior to tumour shrinkage', 'timeFrame': '2-4 weeks', 'description': 'Changes in volume, maximum axial diameter, ADC, F, D, D\\*, T2, R2\\* and enhancing fraction from baseline to post radiotherapy will be presented. A paired T-test (or Wilcoxon Signed Rank Test) may be used to test the difference between baseline and post radiotherapy. Differences in these values will be presented for responders and non-responders, which will be tested by independent T-test. Response will be determined by tumour size, enhancing fraction and histopathological evidence of response.'}], 'secondaryOutcomes': [{'measure': 'To determine the reproducibility of multi-parametric MRI measurements within tumour regions of interest in patients with retroperitoneal sarcoma.', 'timeFrame': '1-7 days', 'description': 'Reproducibility of the parameter ADC-Apparent Diffusion Coefficient (also F, D, D\\*, T2 and R2\\* values)between the two scans at baseline (within 7 days of each other)will be assessed using the Bland Altman method.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Retroperitoneal Sarcoma', 'Magnetic Resonance Imaging'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '31106141', 'type': 'DERIVED', 'citation': 'Winfield JM, Miah AB, Strauss D, Thway K, Collins DJ, deSouza NM, Leach MO, Morgan VA, Giles SL, Moskovic E, Hayes A, Smith M, Zaidi SH, Henderson D, Messiou C. Utility of Multi-Parametric Quantitative Magnetic Resonance Imaging for Characterization and Radiotherapy Response Assessment in Soft-Tissue Sarcomas and Correlation With Histopathology. Front Oncol. 2019 Apr 25;9:280. doi: 10.3389/fonc.2019.00280. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective observational study in which patients with untreated retroperitoneal sarcoma will have Magnetic Resonance Imaging (MRI) prior to surgery. In addition, patients who will be undergoing pre-operative radiotherapy will have an additional MRI scan at two weeks post radiotherapy. For both groups, the magnetic resonance images will be correlated with tumour pathology.\n\nThe study hypothesis is that Magnetic Resonance Imaging will provide a more accurate assessment of tumour volume and local staging than CT and will identify areas of altered oxygenation, cellularity and perfusion which change in response to radiotherapy before tumour shrinkage occurs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with retroperitoneal sarcoma randomised for preoperative radiotherapy plus surgery versus surgery alone.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with retroperitoneal sarcomas planned for surgical resection +/- preoperative radiotherapy.\n\nExclusion Criteria:\n\n* MRI incompatible metal implants\n* claustrophobia'}, 'identificationModule': {'nctId': 'NCT01902667', 'acronym': 'PIRS', 'briefTitle': 'Preoperative Imaging in Retroperitoneal Sarcoma', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Cancer Research, United Kingdom'}, 'officialTitle': 'Preoperative Imaging in Retroperitoneal Sarcoma', 'orgStudyIdInfo': {'id': '13/EE/0186 CCR3992'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Curative intent surgery alone', 'description': 'Patients with retroperitoneal sarcoma randomised into surgery alone arm.', 'interventionNames': ['Procedure: Magnetic Resonance Imaging']}, {'label': 'Pre-operative radiotherapy plus surgery', 'description': 'Patients with retroperitoneal sarcoma randomised to Arm 2: pre-operative radiotherapy plus surgery.', 'interventionNames': ['Procedure: Magnetic Resonance Imaging']}], 'interventions': [{'name': 'Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'armGroupLabels': ['Curative intent surgery alone', 'Pre-operative radiotherapy plus surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'The Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Cancer Research, United Kingdom', 'class': 'OTHER'}, 'collaborators': [{'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'Cancer Research UK', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Translational Imaging', 'investigatorFullName': 'Nandita deSouza', 'investigatorAffiliation': 'Institute of Cancer Research, United Kingdom'}}}}