Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT01308905
Status:
UNKNOWN
Last Update Posted:
2017-04-06
First Post:
2011-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monitor Response to Treatment in Neuroblastoma Using 3&Apos;-Deoxy-3&Apos;-Fluorothymidine- Positron Emission Tomography (FLT-PET)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-07-10', 'releaseDate': '2024-06-16'}, {'resetDate': '2025-07-21', 'releaseDate': '2025-07-02'}], 'estimatedResultsFirstSubmitDate': '2024-06-16'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009447', 'term': 'Neuroblastoma'}], 'ancestors': [{'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'PET scans will be performed to show the distribution throughout the body of substances containing a small amount of radioactive material.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-04', 'studyFirstSubmitDate': '2011-02-22', 'studyFirstSubmitQcDate': '2011-03-03', 'lastUpdatePostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine whether 18F-FLT-PET is a sensitive tool to image neuroblastoma.', 'timeFrame': '1st PET - At diagnosis'}], 'secondaryOutcomes': [{'measure': 'To evaluate the utility of FLT-PET in early assessment of patient response to treatment.', 'timeFrame': '1st PET - At diagnosis'}, {'measure': 'To evaluate the utility of FLT-PET in early assessment of patient response to', 'timeFrame': '2nd PET - Approx. 3 wks (end of 1st cycle)'}, {'measure': 'To evaluate the utility of FLT-PET in early assessment of patient response to treatment.', 'timeFrame': '3rd PET: 6-15 wks (Prior to surgery)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neuroblastoma'], 'conditions': ['Neuroblastoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to gain knowledge about how to best diagnose and treat tumors, how tumors affect normal tissue and how treatment of tumors with radiation therapy and chemotherapy affect tumors.', 'detailedDescription': 'The purpose of this research study is to observe the changes within the tumor cells which may improve the understanding of how tumors grow and how they respond to various treatments. These changes will be compared with results of the physical examination and scans (CT and MRI) that are done as part of clinical care. Images will be made showing the distribution throughout the body of substances containing a small amount of radioactive material. This procedure is called a PET scan. The radioactive substances (tracer compound) in this study are \\[F-18\\] FLT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All patients with neuroblastoma or suspected neuroblastoma seen at Children's Hospital of Michigan (CHM). Patients need to be 2 years or older to be eligible for the initial study\n* Patients must be 1 day to 21 years old, there is no gender limit.\n* Diagnosis: All patients with neuroblastoma or suspected neuroblastoma, including newly diagnosed and relapsed patients, are eligible for Objective 1. To be eligible for Objective 2, patients must have a diagnosis of neuroblastoma verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites, and have measurable disease after the initial surgery\n* Female adolescent patients must have a negative pregnancy test within 14 days of first imaging and should not be pregnant\n* Patients must be able to lie still for the tests, or have no contraindication for sedation\n* Patients or their legal guardian must sign an informed consent indicating that they are aware of the investigational nature of this study\n* A total number of 40-50 patients will be included in the study\n\nExclusion Criteria:\n\n* Patients who do not have a histology diagnosis of neuroblastoma are not eligible for the study\n* Patients whose definite diagnosis after surgery is not consistent with the diagnosis of neuroblastoma will be included in the Objective 1 but excluded for Objective 2."}, 'identificationModule': {'nctId': 'NCT01308905', 'briefTitle': 'Monitor Response to Treatment in Neuroblastoma Using 3&Apos;-Deoxy-3&Apos;-Fluorothymidine- Positron Emission Tomography (FLT-PET)', 'organization': {'class': 'OTHER', 'fullName': 'Barbara Ann Karmanos Cancer Institute'}, 'officialTitle': 'Pilot Study to Determine the Utility of [18F] 3&Apos;-Deoxy-3&Apos;-Fluorothymidine- Positron Emission Tomography in Monitoring Patient Response to Chemotherapy in Neuroblastoma', 'orgStudyIdInfo': {'id': 'WSU 2009-031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FLT-PET', 'description': 'Patients will be managed per COG protocol ANBL00B1 (low risk, LR), ANBL0521 (intermediate risk, IR), ANBL0531 (high risk, HR) or other future neuroblastoma studies according to their risk group (risk assignment, treatment schema and protocols are available in COG website). The following is a brief description of the treatment.\n\n1. Low risk patients: observation only.\n2. Intermediate risk patients: chemotherapy stratified according to risk sub-groups followed by surgical resection.\n3. High risk patients: 6 courses of induction chemotherapy, surgical resection and high dose chemotherapy with autologous stem cell transplant (SCT), involved field radiation and 6 months of Isotrenitoin.\n\nPET scan will be conducted at diagnosis, at the end of the first cycle of treatment and prior to the surgical procedure (resection).', 'interventionNames': ['Device: FLT-PET']}], 'interventions': [{'name': 'FLT-PET', 'type': 'DEVICE', 'description': 'PET scan will be conducted at diagnosis, at the end of the first cycle of treatment and prior to the surgical procedure (resection).', 'armGroupLabels': ['FLT-PET']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Zhihong J Wang, M.D., Ph.D.', 'role': 'CONTACT', 'phone': '313-577-5515'}, {'name': 'Anthony F Shields, M.D., Ph.D.', 'role': 'CONTACT', 'phone': '(313) 576-8735'}, {'name': 'Majid Khalaf, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yaddanapudi Ravindranath, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Diane Chugani, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thomas Mangner, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Otto Muzik, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jeffrey Taub, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sureyya Savasan, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Roland Chu, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kanta Bhambhani, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anthony F Shields, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Children's Hospital of Michigan", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'centralContacts': [{'name': 'Zhihong J Wang, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'jwang2@wayne.edu', 'phone': '(313) 966-7772'}, {'name': 'Anthony F Shields, M.D., Ph.D', 'role': 'CONTACT', 'email': 'shieldsa@karmanos.org', 'phone': '(313) 576-8735'}], 'overallOfficials': [{'name': 'Anthony F. Shields, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barbara Ann Karmanos Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barbara Ann Karmanos Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital of Michigan", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zhihong Wang', 'investigatorAffiliation': 'Barbara Ann Karmanos Cancer Institute'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-06-16', 'type': 'RELEASE'}, {'date': '2024-07-10', 'type': 'RESET'}, {'date': '2025-07-02', 'type': 'RELEASE'}, {'date': '2025-07-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Anthony F. Shields, MD PhD, Principal Investigator, Barbara Ann Karmanos Cancer Institute'}}}}