Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-02-08 @ 12:14 AM
Study NCT ID:
NCT04179968
Status:
COMPLETED
Last Update Posted:
2023-03-20
First Post:
2019-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718244', 'term': 'gallium 68 PSMA-11'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kelli.Key@UTSouthwestern.edu', 'phone': '214-648-8152', 'title': 'Kelli Key, Ph.D.', 'organization': 'UT Southwestern Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Subjects were monitored for adverse events after injection of the investigational agent and were contacted 24 hours after completion of PET/CT imaging to assess any potentially related adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Patients With Suspected Prostate Cancer', 'description': 'Patients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy\n\n68Ga PSMA-11 injection: Injection of 68Ga PSMA-11\n\nPositron Emission Tomography/Computed Tomography: PET/CT scan after 68Ga PSMA-11 injection', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 6, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea without emesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Maculopapular rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Primary Prostate Lesions Detected on Early Dynamic 68Ga-PSMA-11 PET/CT Imaging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Suspected Prostate Cancer', 'description': 'Patients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy\n\n68Ga PSMA-11 injection: Injection of 68Ga PSMA-11\n\nPositron Emission Tomography/Computed Tomography: PET/CT scan after 68Ga PSMA-11 injection'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During PET/CT imaging, up to 2 hours', 'description': 'Number of primary prostate lesions will be detected using early dynamic 68Ga-PSMA-11 PET/CT imaging. PSMA is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protein.', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received a 68Ga-PSMA-11 injection for diagnosis of primary prostate cancer with PET/CT imaging.'}, {'type': 'PRIMARY', 'title': 'Number of Primary Prostate Lesions Detected by mpMRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Suspected Prostate Cancer', 'description': 'Patients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy\n\n68Ga PSMA-11 injection: Injection of 68Ga PSMA-11\n\nPositron Emission Tomography/Computed Tomography: PET/CT scan after 68Ga PSMA-11 injection'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During mpMRI, up to 2 hours', 'description': 'Number of primary prostate lesions will be detected by using mpMRI.', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received a 68Ga-PSMA-11 injection for diagnosis of primary prostate cancer with PET/CT imaging.'}, {'type': 'SECONDARY', 'title': 'Number of Sites of Metastatic Prostate Lesions Detected on 68Ga-PSMA-11 PET/CT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Suspected Prostate Cancer', 'description': 'Patients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy\n\n68Ga PSMA-11 injection: Injection of 68Ga PSMA-11\n\nPositron Emission Tomography/Computed Tomography: PET/CT scan after 68Ga PSMA-11 injection'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During PET/CT imaging, up to 2 hours', 'description': 'Number of sites of metastatic prostate lesions will be detected using 68Ga-PSMA-11 PET/CT. PSMA is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protein.', 'unitOfMeasure': 'sites', 'reportingStatus': 'POSTED', 'populationDescription': '19 patients completed 68Ga-PSMA-11 PET/CT imaging as part of the study.'}, {'type': 'SECONDARY', 'title': 'Number of Sites of Metastatic Prostate Lesions Detected by Current Standard of Care Imaging (CT/MRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Suspected Prostate Cancer', 'description': 'Patients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy\n\n68Ga PSMA-11 injection: Injection of 68Ga PSMA-11\n\nPositron Emission Tomography/Computed Tomography: PET/CT scan after 68Ga PSMA-11 injection'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During CT/MRI imaging, up to 2 hours', 'description': 'Patients with metastatic prostate lesions were imaged using current standard of care imaging (CT/MRI).', 'unitOfMeasure': 'sites', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received a 68Ga-PSMA-11 injection for diagnosis of primary prostate cancer with PET/CT imaging'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients With Suspected Prostate Cancer', 'description': 'Patients with suspected prostate cancer who have at least one Prostate Imaging Reporting \\& Data System (PI-RADS) 5 lesion, or at least one PI-RADS 4 lesion and prostate-specific antigen (PSA) ≥10 nanograms/milliliter (ng/mL), on standard of care multiparametric (mpMRI) of the prostate, who are scheduled for biopsy or radical prostatectomy\n\n68Gallium (68Ga) prostate-specific membrane antigen-11 (PSMA-11) injection: Injection of 68Ga PSMA-11\n\nPositron Emission Tomography (PET)/Computed Tomography (CT): PET/CT scan after 68Ga PSMA-11 injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients With Suspected Prostate Cancer', 'description': 'Patients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy\n\n68Ga PSMA-11 injection: Injection of 68Ga PSMA-11\n\nPositron Emission Tomography/Computed Tomography: PET/CT scan after 68Ga PSMA-11 injection'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.85', 'spread': '8.54', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-10', 'size': 1187632, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-09-06T15:07', 'hasProtocol': True}, {'date': '2020-04-06', 'size': 410501, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-09-06T15:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Unblinded, single arm imaging study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-16', 'studyFirstSubmitDate': '2019-11-25', 'resultsFirstSubmitDate': '2022-09-08', 'studyFirstSubmitQcDate': '2019-11-25', 'lastUpdatePostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-01', 'studyFirstPostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Primary Prostate Lesions Detected on Early Dynamic 68Ga-PSMA-11 PET/CT Imaging', 'timeFrame': 'During PET/CT imaging, up to 2 hours', 'description': 'Number of primary prostate lesions will be detected using early dynamic 68Ga-PSMA-11 PET/CT imaging. PSMA is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protein.'}, {'measure': 'Number of Primary Prostate Lesions Detected by mpMRI', 'timeFrame': 'During mpMRI, up to 2 hours', 'description': 'Number of primary prostate lesions will be detected by using mpMRI.'}], 'secondaryOutcomes': [{'measure': 'Number of Sites of Metastatic Prostate Lesions Detected on 68Ga-PSMA-11 PET/CT', 'timeFrame': 'During PET/CT imaging, up to 2 hours', 'description': 'Number of sites of metastatic prostate lesions will be detected using 68Ga-PSMA-11 PET/CT. PSMA is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protein.'}, {'measure': 'Number of Sites of Metastatic Prostate Lesions Detected by Current Standard of Care Imaging (CT/MRI)', 'timeFrame': 'During CT/MRI imaging, up to 2 hours', 'description': 'Patients with metastatic prostate lesions were imaged using current standard of care imaging (CT/MRI).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PET/CT', 'prostate cancer', 'Gallium-68', 'PSMA-11'], 'conditions': ['Prostate Cancer', 'Prostate Cancer Metastatic']}, 'referencesModule': {'references': [{'pmid': '41077599', 'type': 'DERIVED', 'citation': 'Parrott D, Yuan Q, Pinho D, Xi Y, Costa DN, De Leon AD, Dakanali M, Sun X, Oz OK, Bowen S, Rofsky NM, Mathews D, Pedrosa I. Characterization of suspicious prostate lesions at multiparametric MRI with dynamic 68 Ga-Gozetotide PET/CT. EJNMMI Rep. 2025 Oct 13;9(1):35. doi: 10.1186/s41824-025-00268-2.'}]}, 'descriptionModule': {'briefSummary': 'To goal of this research is to assess the ability of Gallium-68 (68Ga) Prostate-Specific Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to increase diagnostic accuracy in localizing primary and metastatic lesions in patients with suspected prostate cancer and elevated Prostate Imaging Reporting and Data System (PI-RADS) scores and Prostate-Specific Antigen (PSA).', 'detailedDescription': 'This study is designed to evaluate the added value of 68Ga PSMA-11 PET/CT for detection of additional primary prostate cancer lesions compared to multiparametric magnetic resonance imaging (mpMRI) in a group of patients with elevated PI-RADS scores and PSA. We propose that the addition of early dynamic 68Ga PSMA-11 PET/CT imaging to the more usual delayed imaging will enhance detection of primary lesions and additional lesions not detected on the mpMRI. In addition, the dynamic imaging will allow us to evaluate the kinetics of uptake in the prostate gland. It is possible that even in the absence of focal uptake, hyperemia of the gland could indicate the presence of an occult primary.\n\nA second purpose of this research is to examine the value of 68Ga PSMA-11 PET/CT in this same group of patients in detecting metastatic disease at initial staging in comparison with current standard of care imaging such as computed tomography (CT) and magnetic resonance imaging (MRI).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with suspected prostate cancer (e.g., abnormal digital rectal exam, elevated and/or rising PSA) as determined by referring physician\n* Patients must have had a diagnostic, standard of care mpMRI of the prostate with at least one lesion with a PI-RADS v2.1 score ≥ 4\n* In men with PI-RADS v2.1 score 4, PSA should be ≥ 10 ng/mL. In men with at least one PI-RADS v2.1 score 5 lesion, there is no restriction on PSA level.\n* Patients must be scheduled for biopsy or radical prostatectomy\n* Patients should not have had any type of curative or palliative therapy for prostate cancer before enrolling in the study\n* Patients must be medically stable as judged by the patient's physician\n* Patients must be able to lie still for a total of 60 minutes for the PET/CT scans\n* Ability to understand and the willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* Patients who have had a prior prostatectomy or radiotherapy for prostate cancer cannot participate in the study\n* Patients who have had a prior biopsy for prostate cancer cannot participate in the study\n* Patients who have been treated for cancers other than skin cancers\n* Subjects may not be receiving any other investigational agents for the treatment of the cancer under study\n* Patients may not weigh more than the maximum weight limit for the PET/CT scanner table (\\>200 kilograms or 440 pounds)\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11 or other agents used in the study such as gadolinium-based intravenous contrast agent used during the mpMRI\n* Prior transurethral resection of the prostate (TURP)/benign prostatic hyperplasia (BPH) procedures, including steam/laser therapies"}, 'identificationModule': {'nctId': 'NCT04179968', 'briefTitle': 'The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer', 'orgStudyIdInfo': {'id': 'STU-2019-1198'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with suspected prostate cancer', 'description': 'Patients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy', 'interventionNames': ['Drug: 68Ga PSMA-11 injection', 'Procedure: Positron Emission Tomography/Computed Tomography']}], 'interventions': [{'name': '68Ga PSMA-11 injection', 'type': 'DRUG', 'description': 'Injection of 68Ga PSMA-11', 'armGroupLabels': ['Patients with suspected prostate cancer']}, {'name': 'Positron Emission Tomography/Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['PET/CT'], 'description': 'PET/CT scan after 68Ga PSMA-11 injection', 'armGroupLabels': ['Patients with suspected prostate cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Orhan K Oz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana Mathews', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dana Mathews', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}