Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-01-01 @ 7:41 AM
Study NCT ID:
NCT03054792
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-12-13
First Post:
2017-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012208', 'term': 'Rhabdomyosarcoma'}, {'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D009217', 'term': 'Myosarcoma'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D049268', 'term': 'Positron-Emission Tomography'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-09', 'studyFirstSubmitDate': '2017-01-26', 'studyFirstSubmitQcDate': '2017-02-13', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with response to therapy', 'timeFrame': '1 year', 'description': 'Response will be assessed by measurements of tumor volume, percentage of BOLD signal changes, percentage of tumor necrosis, apparent diffusion coefficient, concentration of high-energy and low-energy phosphates in tumor.'}], 'secondaryOutcomes': [{'measure': 'Associations between post-neoadjuvant therapy imaging measurements and surgical / histochemical outcomes in the residual tumor.', 'timeFrame': '1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rhabdomyosarcoma', 'Non-Rhabdo. Soft Tissue Sarcoma']}, 'descriptionModule': {'briefSummary': 'This study will test the feasibility of using novel/existing imaging technologies focused on hypoxia measurements to determine "response to therapy" in pediatric soft tissue sarcomas as a pilot study. Specifically, the investigators will compare the sensitivity of Blood Oxygen Level Dependent \\[BOLD\\], Diffusion-Weighted \\[DW\\] MRI and Magnetic Resonance Spectroscopy (MRS) with that of conventional MRI to detect measurement changes between the start and completion of neoadjuvant therapy ("response to therapy") in children and adolescents (6-18 years) with suspicion of sarcoma tumors. Clinicians and scientists may use results of the proposed hypoxia-imaging surrogate markers to adjust/modify therapeutic schemes to patients on a personalized basis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Referred with a confirmed or suspected sarcoma tumor (rhabdomyosarcoma \\[RMS\\] or non-rhabdomyomatous sarcoma) presenting with an extra-osseous component;\n* Candidate for neoadjuvant therapy that will consist of standard systemic chemotherapy with or without radiation therapy\n\nExclusion Criteria:\n\n* Patients with general contraindications for an MRI scan (metal foreign body, pacemaker, inability to tolerate an examination without sedation);\n* Patients with a known immunodeficiency/sickle cell disease/collagen vascular disease/another malignancy;\n* Patients with no clinical indication for neoadjuvant therapy prior to surgery;\n* Patients with chronic pulmonary disease;\n* Patients with other diagnosis confirmed after initial suspicion of RMS or non-RMS.'}, 'identificationModule': {'nctId': 'NCT03054792', 'briefTitle': 'Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas: Feasibility Steps Toward Personalized Medicine.', 'orgStudyIdInfo': {'id': '1000049533'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BOLD- DW- MRS', 'description': 'Blood Oxygen Level Dependent \\[BOLD\\], Diffusion-Weighted \\[DW\\] MRI, MR Spectroscopy \\[MRS\\]', 'interventionNames': ['Diagnostic Test: Blood Oxygen Level Dependent [BOLD] MRI', 'Diagnostic Test: Diffusion-Weighted [DW] MRI', 'Diagnostic Test: Magnetic Resonance Spectroscopy [MRS]']}], 'interventions': [{'name': 'Blood Oxygen Level Dependent [BOLD] MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'BOLD is a non-invasive T2\\*-weighted MRI technique that is sensitive to the microvascular deoxyhemoglobin concentration. BOLD has the potential to monitor changes in tissue oxygenation in response to a gas breathing challenge to induce contrast.', 'armGroupLabels': ['BOLD- DW- MRS']}, {'name': 'Diffusion-Weighted [DW] MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'DW MRI is a non-invasive technique that provides quantitative biophysical information about the movement of water in tissues and reflects the anisotropy of normal and pathologic cells', 'armGroupLabels': ['BOLD- DW- MRS']}, {'name': 'Magnetic Resonance Spectroscopy [MRS]', 'type': 'DIAGNOSTIC_TEST', 'description': 'MRS is a non-invasive imaging technique that enables the generation of spectral profiles of low molecular weight metabolites that reflect status of a tissue', 'armGroupLabels': ['BOLD- DW- MRS']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD data will be shared with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Radiologist, Scientist, Research Director', 'investigatorFullName': 'Andrea Doria', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}