Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-30 @ 10:34 PM
Study NCT ID:
NCT00783757
Status:
COMPLETED
Last Update Posted:
2017-07-27
First Post:
2008-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TOBI to Monitor Response to Neoadjuvant Therapy in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061848', 'term': 'Optical Imaging'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-25', 'studyFirstSubmitDate': '2008-10-30', 'studyFirstSubmitQcDate': '2008-10-30', 'lastUpdatePostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To explore the feasibility of measuring optically derived parameters in the clinical setting.', 'timeFrame': '4 years'}], 'secondaryOutcomes': [{'measure': 'To explore the changes before and after neoadjuvant therapy of additional parameters derived from dynamic and static optical imaging of primary breast cancer.', 'timeFrame': '4 years'}, {'measure': 'To evaluate changes in optical imaging-derived deoxyhemoglobin concentration early in treatment in patients undergoing neoadjuvant therapy for breast cancer.', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['neo-adjuvant chemotherapy', 'TOBI', 'breast imaging', 'optical imaging'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to see if Near-Infrared Tomographic Optical Breast Imaging (TOBI) scans can help monitor breast tumor response during treatment for breast cancer. The images created by the TOBI scan show changes in blood blow and oxygen levels in breast tissue.', 'detailedDescription': '* Participants will have a TOBI scan prior to starting their cancer treatment and again on day 8 after their first treatment. Participants will also be asked if they would volunteer to undergoing one or more additional TOBI scans on days 2-7 after they begin cancer treatment. These additional scans are optional. Participants will also have a scan on the first day of each treatment cycle.\n* TOBI scans will be performed at the Gillette Center for Breast Cancer at the Massachusetts General Hospital.\n* For the scan, each breast is placed between 2 plastic plates in order to spread the tissue apart, similar to the procedure for a mammogram. The TOBI scanner is attached to these plates. We will apply mild pressure to compress the breast and the breast will be scanned using light waves. Each scan will take about 3 minutes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult female patients presenting to the MGH Cancer Center Gillette Center for breast cancer neoadjuvant therapy\n* Subject who have had or will have a clinically indicated pre-treatment breast MRI\n\nExclusion Criteria:\n\n* Younger than 18 years of age\n* Open wounds on breast\n* Breast implants, because they may interfere with readings\n* Subjects who will be receiving preoperative therapy for \\<28 days\n* Breast surgery or biopsy \\< 10 days prior to optical imaging scan\n* Medical or psychiatric or other medical condition that the principal investigator believes may result in inability to complete the study\n* Bilateral breast cancers or a history of contralateral breast cancer'}, 'identificationModule': {'nctId': 'NCT00783757', 'briefTitle': 'TOBI to Monitor Response to Neoadjuvant Therapy in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Functional Metabolic Near-infrared Tomographic Optical Breast Imaging (TOBI) to Monitor Response to Neoadjuvant Therapy in Breast Cancer', 'orgStudyIdInfo': {'id': '07-305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Optical Imaging', 'description': 'Tomographic Optical Imaging Arm', 'interventionNames': ['Device: Optical Imaging']}], 'interventions': [{'name': 'Optical Imaging', 'type': 'DEVICE', 'otherNames': ['TOBI'], 'description': 'TOBI scan performed before the participant starts cancer treatment and at the start of each treatment cycle', 'armGroupLabels': ['Optical Imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Steven Isakoff, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Steven Isakoff, MD, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Attending Physician', 'investigatorFullName': 'Steven Isakoff, MD, PhD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}