Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT01015820
Status:
COMPLETED
Last Update Posted:
2014-07-16
First Post:
2009-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016145', 'term': 'Endoscopy, Digestive System'}], 'ancestors': [{'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wallace.michael@mayo.edu', 'phone': '904-953-6970', 'title': 'Dr. Michael B. Wallace', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Small sample size, unmatched cohorts'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cancer Group', 'description': 'Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Deoxyhemoglobin Concentration (DHb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cancer Group', 'description': 'Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.'}], 'classes': [{'title': 'Ampullary', 'categories': [{'measurements': [{'value': '.6968475', 'spread': '.22', 'groupId': 'OG000', 'lowerLimit': '.562102', 'upperLimit': '.831593'}, {'value': '.3483283', 'spread': '.20', 'groupId': 'OG001', 'lowerLimit': '.2318606', 'upperLimit': '.4647961'}]}]}, {'title': 'Distal 1 cm from ampullary', 'categories': [{'measurements': [{'value': '.7021826', 'spread': '.35', 'groupId': 'OG000', 'lowerLimit': '.4898464', 'upperLimit': '.9145189'}, {'value': '.4945491', 'spread': '.28', 'groupId': 'OG001', 'lowerLimit': '.3416003', 'upperLimit': '.647498'}]}]}, {'title': 'Distal periampullary', 'categories': [{'measurements': [{'value': '.4442996', 'spread': '.15', 'groupId': 'OG000', 'lowerLimit': '.3415441', 'upperLimit': '.5470551'}, {'value': '.4831275', 'spread': '.17', 'groupId': 'OG001', 'lowerLimit': '.3904288', 'upperLimit': '.5758262'}]}]}, {'title': 'Proximal 1 cm from ampulla', 'categories': [{'measurements': [{'value': '.6885187', 'spread': '.29', 'groupId': 'OG000', 'lowerLimit': '.5013549', 'upperLimit': '.8756826'}, {'value': '.4654624', 'spread': '.34', 'groupId': 'OG001', 'lowerLimit': '.2776132', 'upperLimit': '.6533117'}]}]}, {'title': 'Proximal periampullary', 'categories': [{'measurements': [{'value': '.4785118', 'spread': '.22', 'groupId': 'OG000', 'lowerLimit': '.3417855', 'upperLimit': '.6152382'}, {'value': '.43211449', 'spread': '.33', 'groupId': 'OG001', 'lowerLimit': '.2399311', 'upperLimit': '.6243588'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Statistical significance p ≤ 0.05', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation', 'description': 'Deoxygenated hemoglobin is the form of hemoglobin without the bound oxygen. It serves as a marker for early increase of blood supply (EIBS). DHb concentration was determined spectroscopically from five peri-ampullary locations.', 'unitOfMeasure': 'alpha units', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Among the 15 participants in the cancer group, 1 participant was excluded from the final analysis due to suboptimal measurements. Therefore 14 participants in the cancer group and 15 participants in the control group were included in the analysis population.'}, {'type': 'PRIMARY', 'title': 'Mean Blood Vessel Radius (BVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cancer Group', 'description': 'Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.'}], 'classes': [{'title': 'Ampullary', 'categories': [{'measurements': [{'value': '.003088', 'spread': '.001', 'groupId': 'OG000', 'lowerLimit': '.0022698', 'upperLimit': '.0039062'}, {'value': '.002035', 'spread': '.001', 'groupId': 'OG001', 'lowerLimit': '.0016118', 'upperLimit': '.0024582'}]}]}, {'title': 'Distal 1 cm from Ampulla', 'categories': [{'measurements': [{'value': '.0030272', 'spread': '.001', 'groupId': 'OG000', 'lowerLimit': '.0022997', 'upperLimit': '.0037547'}, {'value': '.0023467', 'spread': '.001', 'groupId': 'OG001', 'lowerLimit': '.0019386', 'upperLimit': '.0027548'}]}]}, {'title': 'Distal Periampullary', 'categories': [{'measurements': [{'value': '.002899', 'spread': '.001', 'groupId': 'OG000', 'lowerLimit': '.0021021', 'upperLimit': '.0036958'}, {'value': '.0024096', 'spread': '.001', 'groupId': 'OG001', 'lowerLimit': '.0021024', 'upperLimit': '.0027168'}]}]}, {'title': 'Proximal 1 cm from Ampulla', 'categories': [{'measurements': [{'value': '.0027802', 'spread': '.001', 'groupId': 'OG000', 'lowerLimit': '.0021426', 'upperLimit': '.0034178'}, {'value': '.0020825', 'spread': '.001', 'groupId': 'OG001', 'lowerLimit': '.0015238', 'upperLimit': '.0026411'}]}]}, {'title': 'Proximal Periampullary', 'categories': [{'measurements': [{'value': '.0023551', 'spread': '.001', 'groupId': 'OG000', 'lowerLimit': '.001627', 'upperLimit': '.0030832'}, {'value': '.0019793', 'spread': '.001', 'groupId': 'OG001', 'lowerLimit': '.0014618', 'upperLimit': '.0024968'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Statistical significance p ≤ 0.05', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation', 'description': 'BVR serves as a marker for early increase of blood supply (EIBS).', 'unitOfMeasure': 'cm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Among the 15 participants in the cancer group, 1 participant was excluded from the final analysis due to suboptimal measurements. Therefore 14 participants in the cancer group and 15 participants in the control group were included in the analysis population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cancer Group', 'description': 'Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an esophagogastroduodenoscopy (EGD) with endoscopic ultrasound (EUS). During the EUS, blood flow was measured in the duodenum with the Four-dimensional Elastic Light-Scattering Fingerprinting (4D-ELF) device.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Suboptimal measurements', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '37 patients were enrolled in the study. Of these, 5 patients with neuroendocrine tumors and 2 patients with duodenal anatomy limiting the use of the probe were excluded because of screen failure.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cancer Group', 'description': 'Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72', 'spread': '10', 'groupId': 'BG000'}, {'value': '63', 'spread': '11', 'groupId': 'BG001'}, {'value': '67', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Among the 15 participants in the cancer group, 1 participant was excluded from the final analysis due to suboptimal measurements. Therefore 14 participants in the cancer group and 15 participants in the control group were included in the baseline analysis population.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-03', 'studyFirstSubmitDate': '2009-11-12', 'resultsFirstSubmitDate': '2014-05-29', 'studyFirstSubmitQcDate': '2009-11-17', 'lastUpdatePostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-29', 'studyFirstPostDateStruct': {'date': '2009-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Deoxyhemoglobin Concentration (DHb)', 'timeFrame': 'Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation', 'description': 'Deoxygenated hemoglobin is the form of hemoglobin without the bound oxygen. It serves as a marker for early increase of blood supply (EIBS). DHb concentration was determined spectroscopically from five peri-ampullary locations.'}, {'measure': 'Mean Blood Vessel Radius (BVR)', 'timeFrame': 'Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation', 'description': 'BVR serves as a marker for early increase of blood supply (EIBS).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pancreatic Cancer', 'Duodenum', 'Spectroscopy', 'Fiberoptic probe', '4D-ELF'], 'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '24861243', 'type': 'RESULT', 'citation': 'Patel M, Gomes A, Ruderman S, Hardee D, Crespo S, Raimondo M, Woodward T, Backman V, Roy H, Wallace M. Polarization gating spectroscopy of normal-appearing duodenal mucosa to detect pancreatic cancer. Gastrointest Endosc. 2014 Nov;80(5):786-93.e1-2. doi: 10.1016/j.gie.2014.03.031. Epub 2014 May 24.'}]}, 'descriptionModule': {'briefSummary': 'Pancreatic cancer is the fourth leading cause of cancer death in the United States and is associated with a poor prognosis. The average life expectancy after diagnosis is approximately 5 to 8 months. At present, successful surgical resection is the only curative therapy that can improve long-term survival. However, it can be achieved only when a tumor is detected at an early stage. Unfortunately, due to non-specific symptoms associated with pancreatic cancer, it is commonly detected in the later stages of the disease.\n\nThe investigators hypothesized that pancreatic cancer could be detected by measuring the changes in the early increase in blood supply (EIBS) found in the surrounding normal-appearing duodenal tissue. The investigators tested a device called Four-dimensional Elastic Light-Scattering Fingerprinting (4D-ELF). The device used in this study is considered investigational, which means it has either not been approved by the Food and Drug Administration (FDA) for routine clinical use or for the use described in this study. However the FDA allowed the use of this device in this research study.', 'detailedDescription': "According to field effect theory, by detecting microvasculature changes in the early increase of blood supply in the surrounding tissue neoplastic lesions can be identified from a distance.\n\nThe objective of this study was to determine the feasibility and efficacy of a fiberoptic probe containing novel Polarization Gating Spectroscopy (PGS) technology to identify patients with pancreatic adenocarcinoma (PAC) by field effect theory. EIBS markers, deoxyhemoglobin concentration (DHb), and average blood vessel radius (BVR) were evaluated in patients with PAC versus controls.\n\nDuring the subjects' esophagogastroduodenoscopy (EGD) with upper endoscopic ultrasound (EUS), the new optic probe was inserted inside the endoscope and advanced to the tip of the endoscope prior to the scope being withdrawn. As the scope was withdrawn, the light optic probe was used to examine approximately 5 sections of the small bowel: 1) directly on the ampulla, 2) approximately 5 mm proximal from the ampulla, 3) approximately 5 mm distal from the ampulla, 4) 1 cm proximal from the ampulla, and 5) 1 cm distal from the ampulla. Spectroscopy measurements were obtained four times in each of these five peri-ampullary locations. The rest of the EGD and upper EUS endoscopy procedures were then completed as clinically indicated. During the procedure, all visualized mucosal abnormalities were recorded and photographed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older.\n* Informed written consent.\n* Patient scheduled for previously planned EGD with upper EUS\n* Patients with known adenocarcinoma of the pancreas included in the cancer group\n* Patients with abdominal imaging studies (e.g., CT abdomen or MRI abdomen) negative for malignancy in past 5 years included in the control group.\n\nExclusion Criteria:\n\n* Unable to obtain biopsy specimen or fine-needle aspiration results of the pancreas lesion (e.g., coagulation disorder, inadequate sample)\n* Presence of malignant lesion in the pancreas or duodenum other than pancreas adenocarcinoma (e.g., neuroendocrine tumor, gastrointestinal stromal tumor)\n* Known familial disorder with high risk of pancreas cancer development (e.g., familial adenomatous polyposis syndrome, hereditary non-polyposis colorectal cancer syndrome, juvenile polyposis syndrome)\n* Significant family history of pancreatic cancer (at least one first degree relative with pancreatic cancer)\n* Presence of premalignant lesions (e.g., duodenal adenoma, pancreas intraductal papillary mucinous neoplasm)\n* Active visible inflammation/ulcer in the stomach or the duodenum\n* Patients with known chronic pancreatitis were excluded from cancer group. Chronic pancreatitis patients were allowed to be included in the control group only.\n* Known pregnancy or sexually active females of childbearing age who are not practicing an accepted form of birth control.'}, 'identificationModule': {'nctId': 'NCT01015820', 'briefTitle': 'Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Detectable Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer', 'orgStudyIdInfo': {'id': '09-002596'}, 'secondaryIdInfos': [{'id': 'R01CA128641', 'link': 'https://reporter.nih.gov/quickSearch/R01CA128641', 'type': 'NIH'}, {'id': 'R01CA156186', 'link': 'https://reporter.nih.gov/quickSearch/R01CA156186', 'type': 'NIH'}, {'id': 'R01EB003682', 'link': 'https://reporter.nih.gov/quickSearch/R01EB003682', 'type': 'NIH'}, {'id': 'U01CA111257', 'link': 'https://reporter.nih.gov/quickSearch/U01CA111257', 'type': 'NIH'}, {'id': 'CBET-1240416', 'type': 'OTHER_GRANT', 'domain': 'National Science Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cancer group', 'description': 'Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.', 'interventionNames': ['Procedure: EGD with EUS', 'Device: 4D-ELF']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.', 'interventionNames': ['Procedure: EGD with EUS', 'Device: 4D-ELF']}], 'interventions': [{'name': 'EGD with EUS', 'type': 'PROCEDURE', 'description': 'EUS was performed in order to measure blood flow in duodenum.', 'armGroupLabels': ['Cancer group', 'Control group']}, {'name': '4D-ELF', 'type': 'DEVICE', 'description': 'During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.', 'armGroupLabels': ['Cancer group', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32223', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Michael B. Wallace, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northwestern University', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'National Institute for Biomedical Imaging and Bioengineering (NIBIB)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Michael Wallace', 'investigatorAffiliation': 'Mayo Clinic'}}}}