Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-26 @ 12:59 AM
Study NCT ID:
NCT03458234
Status:
TERMINATED
Last Update Posted:
2024-05-20
First Post:
2018-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
RAD 1801: Pilot Study of Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-05-07', '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ammcdonald@uabmc.edu', 'phone': '(205) 934-5670', 'title': 'Andrew McDonald, MD; Principal Investigator', 'organization': 'University of Alabama at Birmingham (UAB)'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '5 patients signed consent, 1 patient withdrew consent prior to start of treatment. The funding source informed they are no longer manufacturing radiotransponder. No similar product. Therefore, no longer proceeding with study and no data collected.'}}, 'adverseEventsModule': {'timeFrame': 'Each participant was assessed at baseline, during time of treatment, and during follow-up at 3, 6, 9, 12, 18, and 24 months after completion of treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Focal SBRT With Intra-urethral Radiotransponder', 'description': "This study will enroll patients that have a confirmed histology of prostate cancer. They will undergo a 3T MRI scan as well as a CT simulation with 16 French Foley Catheter containing dummy beacons for treatment planning purposes. The patient will then receive focal stereotactic body radiotherapy (SBRT) at a dose of 40 gy in 5 total fractions. Patients will be followed for 24 total months with specific follow-ups at 3, 6, 9, 12, 18, and 24 months.\n\n16 French Foley Catheter: A Foley catheter is a medical apparatus that creates a passageway for the drainage and collection of urine. This type of catheter is made of a pliable material that indwells into an individual's bladder by way of the urethra.\n\nFeaturing two separate channels down the tube, Foley catheters allow absolute stability and safe extraction. One channel of the catheter, by method of a balloon, is stabilized in a bladder; the other channel allows for the passage and collection of urine, by means of a leg bag or bedside drainage bag.\n\nFoley catheters are usually constructed out of either silicone or latex.", 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Confirm the Feasibility of Focal Prostate Stereotactic Body Radiotherapy (SBRT) With Real Time Guidance by Intra-urethral Radiotransponder Beacons.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Focal SBRT With Intra-urethral Radiotransponder', 'description': "This study will enroll patients that have a confirmed histology of prostate cancer. They will undergo a 3T MRI scan as well as a CT simulation with 16 French Foley Catheter containing dummy beacons for treatment planning purposes. The patient will then receive focal stereotactic body radiotherapy (SBRT) at a dose of 40 gy in 5 total fractions. Patients will be followed for 24 total months with specific follow-ups at 3, 6, 9, 12, 18, and 24 months.\n\n16 French Foley Catheter: A Foley catheter is a medical apparatus that creates a passageway for the drainage and collection of urine. This type of catheter is made of a pliable material that indwells into an individual's bladder by way of the urethra.\n\nFeaturing two separate channels down the tube, Foley catheters allow absolute stability and safe extraction. One channel of the catheter, by method of a balloon, is stabilized in a bladder; the other channel allows for the passage and collection of urine, by means of a leg bag or bedside drainage bag.\n\nFoley catheters are usually constructed out of either silicone or latex."}], 'timeFrame': '2 years', 'description': 'Confirm the technical feasibility of using focal prostate stereotactic body radiotherapy (SBRT) instead of traditional treatment methods using a 16-french Foley catheter and real time guidance by intra-urethral radiotransponder beacons.Feasibility will be defined as the ability of the treatment to take place as planned.', 'reportingStatus': 'POSTED', 'populationDescription': '5 patients signed consent, 1 patient withdrew consent prior to start of treatment. The funding source informed they are no longer manufacturing radiotransponder. No similar product. Therefore, no longer proceeding with study and no data collected.'}, {'type': 'SECONDARY', 'title': 'Assess Early Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Focal SBRT With Intra-urethral Radiotransponder', 'description': "This study will enroll patients that have a confirmed histology of prostate cancer. They will undergo a 3T MRI scan as well as a CT simulation with 16 French Foley Catheter containing dummy beacons for treatment planning purposes. The patient will then receive focal stereotactic body radiotherapy (SBRT) at a dose of 40 gy in 5 total fractions. Patients will be followed for 24 total months with specific follow-ups at 3, 6, 9, 12, 18, and 24 months.\n\n16 French Foley Catheter: A Foley catheter is a medical apparatus that creates a passageway for the drainage and collection of urine. This type of catheter is made of a pliable material that indwells into an individual's bladder by way of the urethra.\n\nFeaturing two separate channels down the tube, Foley catheters allow absolute stability and safe extraction. One channel of the catheter, by method of a balloon, is stabilized in a bladder; the other channel allows for the passage and collection of urine, by means of a leg bag or bedside drainage bag.\n\nFoley catheters are usually constructed out of either silicone or latex."}], 'timeFrame': 'Within 6 months of completion of radiation therapy', 'description': 'Clinically assess early efficacy for men receiving focal prostate SBRT for low and low-intermediate risk prostate cancer.Efficacy will be defined as the absence of biochemically detected (via PSA lab testing) prostate cancer or clinically detected prostate cancer', 'reportingStatus': 'POSTED', 'populationDescription': '5 patients signed consent, 1 patient withdrew consent prior to start of treatment. The funding source informed they are no longer manufacturing radiotransponder. No similar product. Therefore, no longer proceeding with study and no data collected.'}, {'type': 'SECONDARY', 'title': 'Assess Late Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Focal SBRT With Intra-urethral Radiotransponder', 'description': "This study will enroll patients that have a confirmed histology of prostate cancer. They will undergo a 3T MRI scan as well as a CT simulation with 16 French Foley Catheter containing dummy beacons for treatment planning purposes. The patient will then receive focal stereotactic body radiotherapy (SBRT) at a dose of 40 gy in 5 total fractions. Patients will be followed for 24 total months with specific follow-ups at 3, 6, 9, 12, 18, and 24 months.\n\n16 French Foley Catheter: A Foley catheter is a medical apparatus that creates a passageway for the drainage and collection of urine. This type of catheter is made of a pliable material that indwells into an individual's bladder by way of the urethra.\n\nFeaturing two separate channels down the tube, Foley catheters allow absolute stability and safe extraction. One channel of the catheter, by method of a balloon, is stabilized in a bladder; the other channel allows for the passage and collection of urine, by means of a leg bag or bedside drainage bag.\n\nFoley catheters are usually constructed out of either silicone or latex."}], 'timeFrame': 'Within 6 months of completion of radiation therapy', 'description': 'Clinically assess late toxicity for men receiving focal prostate SBRT for low and low-intermediate risk prostate cancer. Late toxicity (defined as toxicity occurring \\>90 days after treatment) will be assessed with regular clinical exams and patient toxicity questionnaires.', 'reportingStatus': 'POSTED', 'populationDescription': '5 patients signed consent, 1 patient withdrew consent prior to start of treatment. The funding source informed they are no longer manufacturing radiotransponder. No similar product. Therefore, no longer proceeding with study and no data collected.'}, {'type': 'SECONDARY', 'title': 'Assess Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Focal SBRT With Intra-urethral Radiotransponder', 'description': "This study will enroll patients that have a confirmed histology of prostate cancer. They will undergo a 3T MRI scan as well as a CT simulation with 16 French Foley Catheter containing dummy beacons for treatment planning purposes. The patient will then receive focal stereotactic body radiotherapy (SBRT) at a dose of 40 gy in 5 total fractions. Patients will be followed for 24 total months with specific follow-ups at 3, 6, 9, 12, 18, and 24 months.\n\n16 French Foley Catheter: A Foley catheter is a medical apparatus that creates a passageway for the drainage and collection of urine. This type of catheter is made of a pliable material that indwells into an individual's bladder by way of the urethra.\n\nFeaturing two separate channels down the tube, Foley catheters allow absolute stability and safe extraction. One channel of the catheter, by method of a balloon, is stabilized in a bladder; the other channel allows for the passage and collection of urine, by means of a leg bag or bedside drainage bag.\n\nFoley catheters are usually constructed out of either silicone or latex."}], 'timeFrame': 'Within 6 months of completion of radiation therapy', 'description': 'Clinically assess quality of life for men receiving focal prostate SBRT for low and low-intermediate risk prostate cancer. Late quality of life will be assessed with regular clinical exams and patient quality of life questionnaires.', 'reportingStatus': 'POSTED', 'populationDescription': '5 patients signed consent, 1 patient withdrew consent prior to start of treatment. The funding source informed they are no longer manufacturing radiotransponder. No similar product. Therefore, no longer proceeding with study and no data collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Focal SBRT With Intra-urethral Radiotransponder', 'description': "This study will enroll patients that have a confirmed histology of prostate cancer. They will undergo a 3T MRI scan as well as a CT simulation with 16 French Foley Catheter containing dummy beacons for treatment planning purposes. The patient will then receive focal stereotactic body radiotherapy (SBRT) at a dose of 40 gy in 5 total fractions. Patients will be followed for 24 total months with specific follow-ups at 3, 6, 9, 12, 18, and 24 months.\n\n16 French Foley Catheter: A Foley catheter is a medical apparatus that creates a passageway for the drainage and collection of urine. This type of catheter is made of a pliable material that indwells into an individual's bladder by way of the urethra.\n\nFeaturing two separate channels down the tube, Foley catheters allow absolute stability and safe extraction. One channel of the catheter, by method of a balloon, is stabilized in a bladder; the other channel allows for the passage and collection of urine, by means of a leg bag or bedside drainage bag.\n\nFoley catheters are usually constructed out of either silicone or latex."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Focal SBRT With Intra-urethral Radiotransponder', 'description': "This study will enroll patients that have a confirmed histology of prostate cancer. They will undergo a 3T MRI scan as well as a CT simulation with 16 French Foley Catheter containing dummy beacons for treatment planning purposes. The patient will then receive focal stereotactic body radiotherapy (SBRT) at a dose of 40 gy in 5 total fractions. Patients will be followed for 24 total months with specific follow-ups at 3, 6, 9, 12, 18, and 24 months.\n\n16 French Foley Catheter: A Foley catheter is a medical apparatus that creates a passageway for the drainage and collection of urine. This type of catheter is made of a pliable material that indwells into an individual's bladder by way of the urethra.\n\nFeaturing two separate channels down the tube, Foley catheters allow absolute stability and safe extraction. One channel of the catheter, by method of a balloon, is stabilized in a bladder; the other channel allows for the passage and collection of urine, by means of a leg bag or bedside drainage bag.\n\nFoley catheters are usually constructed out of either silicone or latex."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '5', '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': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-12', 'size': 612580, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-03T13:40', 'hasProtocol': True}, {'date': '2023-03-15', 'size': 170157, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-04-03T13:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'No longer manufacturing radiotransponder beacons. No similar product available. The results are no longer expected to have a scholarly or clinical impact. Terminating the study before it reaches its target accrual.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-13', 'studyFirstSubmitDate': '2018-03-01', 'resultsFirstSubmitDate': '2024-04-12', 'studyFirstSubmitQcDate': '2018-03-01', 'lastUpdatePostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-13', 'studyFirstPostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirm the Feasibility of Focal Prostate Stereotactic Body Radiotherapy (SBRT) With Real Time Guidance by Intra-urethral Radiotransponder Beacons.', 'timeFrame': '2 years', 'description': 'Confirm the technical feasibility of using focal prostate stereotactic body radiotherapy (SBRT) instead of traditional treatment methods using a 16-french Foley catheter and real time guidance by intra-urethral radiotransponder beacons.Feasibility will be defined as the ability of the treatment to take place as planned.'}], 'secondaryOutcomes': [{'measure': 'Assess Early Efficacy', 'timeFrame': 'Within 6 months of completion of radiation therapy', 'description': 'Clinically assess early efficacy for men receiving focal prostate SBRT for low and low-intermediate risk prostate cancer.Efficacy will be defined as the absence of biochemically detected (via PSA lab testing) prostate cancer or clinically detected prostate cancer'}, {'measure': 'Assess Late Toxicity', 'timeFrame': 'Within 6 months of completion of radiation therapy', 'description': 'Clinically assess late toxicity for men receiving focal prostate SBRT for low and low-intermediate risk prostate cancer. Late toxicity (defined as toxicity occurring \\>90 days after treatment) will be assessed with regular clinical exams and patient toxicity questionnaires.'}, {'measure': 'Assess Quality of Life', 'timeFrame': 'Within 6 months of completion of radiation therapy', 'description': 'Clinically assess quality of life for men receiving focal prostate SBRT for low and low-intermediate risk prostate cancer. Late quality of life will be assessed with regular clinical exams and patient quality of life questionnaires.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Focal therapy', 'Prostate cancer', 'SBRT', 'Intra-urethral transponder'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This study offers focal therapy for prostate cancer by using an intra-urethral radiotransponder temporarily placed during radiotherapy. The study aims to improve the risk-benefit ratio of therapy for early prostate cancer and potentially lessen symptom burden over time.', 'detailedDescription': 'This study offers focal stereotactic body radiotherapy for prostate cancer by using an intra-urethral radiotransponder placed temporarily during each of the 5 radiotherapy treatments. The study aims to improve the risk-benefit ratio of therapy for early prostate cancer and potentially lessen symptom burden over time while also accessing early efficacy, late toxicity, and overall quality of life post-treatment. Patients will be followed for 24 months (2 years) with follow-up appointments at 3, 6, 9, 12, 18, and 24 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients must have histologically confirmed adenocarcinoma of the prostate, with biopsies obtained within 12 months of registration\n\n * Gleason score 3+3 or 3+4\n * PSA \\<10 ng/mL within 3 months of enrollment\n * Clinical stage T1a-T2a by digital rectal exam\n * Up to 2 intraprostatic nodules visible on MRI, with combined volume \\<50% of the total prostate volume\n* Karnofsky Performance Status (KPS) \\>70%.\n* Life expectancy \\>10 years\n* Age ≥ 19 years\n* Subjects given written informed consent\n\nExclusion Criteria:\n\n* \\>2 MRI defined nodules representing prostate cancer\n* Total volume of MRI nodules exceeding 50% of total prostate volume\n* Positive biopsy core in sextant region without MRI defined nodule (i.e. biopsy proven MRI occult prostate cancer)\n* American Urological Association (AUA) urinary score ≥ 18.\n* History of inflammatory bowel disease.\n* Prior pelvic surgery\n* Prior treatment for prostate cancer\n* Patients using immunosuppressive medications or other medications that may increase radiation toxicity such as methotrexate, sirolimus, tacrolimus, or colchicine that are unable to discontinue these medications during SBRT course. Use of corticosteroids is not considered an exclusion criteria.\n* Platelet count \\< 70,000/µL\n* Patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin. Use of aspirin is not an exclusion criteria.\n* Contraindication to MRI such as implanted devices.\n* Metallic pelvic implants resulting in imaging artifact within the prostate on MRI or CT'}, 'identificationModule': {'nctId': 'NCT03458234', 'acronym': 'RAD1801', 'briefTitle': 'RAD 1801: Pilot Study of Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Pilot Study of Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy', 'orgStudyIdInfo': {'id': 'IRB-300002183'}, 'secondaryIdInfos': [{'id': '000521070', 'type': 'OTHER_GRANT', 'domain': 'Varian Medical Systems'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Focal SBRT with intra-urethral radiotransponder', 'description': 'This study will enroll patients that have a confirmed histology of prostate cancer. They will undergo a 3T MRI scan as well as a CT simulation with 16 French Foley Catheter containing dummy beacons for treatment planning purposes. The patient will then receive focal stereotactic body radiotherapy (SBRT) at a dose of 40 gy in 5 total fractions. Patients will be followed for 24 total months with specific follow-ups at 3, 6, 9, 12, 18, and 24 months.', 'interventionNames': ['Device: 16 French Foley Catheter']}], 'interventions': [{'name': '16 French Foley Catheter', 'type': 'DEVICE', 'description': "A Foley catheter is a medical apparatus that creates a passageway for the drainage and collection of urine. This type of catheter is made of a pliable material that indwells into an individual's bladder by way of the urethra.\n\nFeaturing two separate channels down the tube, Foley catheters allow absolute stability and safe extraction. One channel of the catheter, by method of a balloon, is stabilized in a bladder; the other channel allows for the passage and collection of urine, by means of a leg bag or bedside drainage bag.\n\nFoley catheters are usually constructed out of either silicone or latex.", 'armGroupLabels': ['Focal SBRT with intra-urethral radiotransponder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Hazelrig-Salter Radiation Oncology Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Andrew M McDonald, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Varian Medical Systems', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor - Department of Radiation Oncology', 'investigatorFullName': 'Andrew McDonald', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}