Ignite Creation Date:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2026-01-03 @ 3:43 AM
Study NCT ID:
NCT01660412
Status:
COMPLETED
Last Update Posted:
2017-11-20
First Post:
2012-08-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Does Alkalinization Reduce Perceived Pain Levels During Sentinel Lymph Node Imaging?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jantambi@uams.edu', 'phone': '5015265062', 'title': 'James A Ntambi', 'organization': 'UAMS'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'a sample size of 60 may be inadequate to generalize to all practices.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored for each injection up to 5 minutes.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard of Care Injection', 'description': 'Approximately 1mc 99mTc-SC', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 11, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PH Altered Injection', 'description': 'a diluted bicarbonate solution in a drop wise manner to raise the pH of the 99mTc-SC to a pH of 7.40 ± 0.05, dose Approximately 1mc', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection Site Pain', 'notes': 'Injection site pain of 8 of 10 or less was not considered an adverse event. Injection site pain of 9/10 or 10/10 was considered an adverse event.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Perceived Pain Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Injection', 'description': 'Approximately 1mc 99mTc-SC'}, {'id': 'OG001', 'title': 'PH Altered Injection', 'description': 'a diluted bicarbonate solution in a drop wise manner to raise the pH of the 99mTc-SC to a pH of 7.40 ± 0.05, dose Approximately 1mc'}], 'classes': [{'categories': [{'measurements': [{'value': '5.81', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '4.39', 'spread': '2.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.42', 'ciLowerLimit': '0.85', 'ciUpperLimit': '2.00', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.17', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'immediately after administration (<1 min) of each injection (up to total 5 minutes)', 'description': 'Immediately after receiving an injection, subjects will rate their perceived pain level, using a validated measure. Subject was asked to quantify the pain of every injection using a validated scale from 0 through 10, with 0 being no pain and 10 being severe pain that is disabling. The effect of treatment was estimated by taking the difference of the mean buffered and SOC pain scores and a paired t-test was used to test whether the mean difference was significantly different from 0. Perceived pain levels assessed after each injection were averaged for each participant.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'pH Altered First', 'description': 'The first injection administered will be the pH altered solution. The second injection will be the standard of care solution (opposite order). The remaining injections will be randomly assigned as either standard of care or pH altered.\n\nph Altered first: For the first injection, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to \\~7.40. For the second injection, the standard of care will be given, and randomly after that either standard of care, or pH altered will be given.'}, {'id': 'FG001', 'title': 'Standard of Care First', 'description': 'The first injection administered will be the standard of care solution (SOC). The second injection will be the pH altered solution. The remaining injections will be randomly assigned as either standard of care or pH altered.\n\nStandard of Care First: For the second injection, and randomly after that, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to \\~7.40.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'Head', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Thorax', 'comment': 'Including neck and buttocks', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Appendicular Structures', 'comment': 'including shoulder to wrist, back of hand, and hip to ankle', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Other', 'comment': 'Remainder of the hand and feet', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Injection 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'Injection 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'Injection 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'Injection 4', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'Each Participant received four injections. We tested four different injection sites. Each participant received all four injections at one site.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Subjects were randomized into 1 of 2 sequence groups (A and B):\n\nSequence group A. The first injection administered was the standard-of-care (SOC) solution followed by the pH-altered solution. The remaining injections were randomly assigned as either SOC solution or pH-altered.\n\nSequence group B. The first injection administered was the pHaltered solution followed by the SOC solution. The remaining injections were randomly assigned as either SOC solution or pH-altered.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '13.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '159.9', 'spread': '46.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'lbs', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-01-17', 'size': 175078, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-11-16T10:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-16', 'studyFirstSubmitDate': '2012-08-03', 'resultsFirstSubmitDate': '2017-11-14', 'studyFirstSubmitQcDate': '2012-08-06', 'lastUpdatePostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-16', 'studyFirstPostDateStruct': {'date': '2012-08-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived Pain Level', 'timeFrame': 'immediately after administration (<1 min) of each injection (up to total 5 minutes)', 'description': 'Immediately after receiving an injection, subjects will rate their perceived pain level, using a validated measure. Subject was asked to quantify the pain of every injection using a validated scale from 0 through 10, with 0 being no pain and 10 being severe pain that is disabling. The effect of treatment was estimated by taking the difference of the mean buffered and SOC pain scores and a paired t-test was used to test whether the mean difference was significantly different from 0. Perceived pain levels assessed after each injection were averaged for each participant.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pain', 'Alkalinization', 'Technetium 99m Sulfur Colloid', 'sentinel lymphoscintigraphy?'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '18676334', 'type': 'BACKGROUND', 'citation': 'Fetzer S, Holmes S. Relieving the pain of sentinel lymph node biopsy tracer injection. Clin J Oncol Nurs. 2008 Aug;12(4):668-70. doi: 10.1188/08.CJON.668-670.'}, {'pmid': '19664956', 'type': 'BACKGROUND', 'citation': 'Stojadinovic A, Peoples GE, Jurgens JS, Howard RS, Schuyler B, Kwon KH, Henry LR, Shriver CD, Buckenmaier CC. Standard versus pH-adjusted and lidocaine supplemented radiocolloid for patients undergoing sentinel-lymph-node mapping and biopsy for early breast cancer (PASSION-P trial): a double-blind, randomised controlled trial. Lancet Oncol. 2009 Sep;10(9):849-54. doi: 10.1016/S1470-2045(09)70194-9. Epub 2009 Aug 5.'}, {'pmid': '26222533', 'type': 'RESULT', 'citation': 'Johnston MJ, Ntambi JA, Hilliard N, Spencer HJ, Vaughn R, Owens SS, Myrick RS, Parker LD, Garner DA, Yarbrough TL. Reducing perceived pain levels during nonbreast lymphoscintigraphy. Clin Nucl Med. 2015 Dec;40(12):945-9. doi: 10.1097/RLU.0000000000000905.'}]}, 'descriptionModule': {'briefSummary': "Pain during nuclear medicine breast lymphnode detection procedures has been reported as high as 8.8/10. Using Sodium Bicarbonate to alkalinize the radio-pharmaceutical injection, pain can safely be reduced from 6.6/10 to 4.7/10, during breast lymph node detection procedures.\n\nIn sites other then the breast, using Bicarbonate to make the injection's pH closer to natural, attempts to lower the pain levels will be performed.\n\nHypothesis: The perceived pain level during non breast sentinel lymph node techniques can be reduced by raising the pH of the injectate (Tc-99m SC) to near the physiologic level of pH 7.40."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '122 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting for SLN imaging for melanoma or who have had an excisional biopsy for melanoma of the thorax and appendicular structures;\n* Patients scheduled to receive two or more injections of Tc-99m SC for the purpose of clinical management of melanoma or who have had an excisional biopsy for melanoma of the thorax and appendicular structures.\n\nExclusion Criteria:\n\n* Patients presenting for SLN imaging of lesions involving the breast, ear, nose, and genitourinary regions;\n* Patients scheduled to receive only a single injection of Tc-99m SC;\n* Pregnant or breast feeding women.'}, 'identificationModule': {'nctId': 'NCT01660412', 'acronym': 'buffering SLN', 'briefTitle': 'Does Alkalinization Reduce Perceived Pain Levels During Sentinel Lymph Node Imaging?', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Does Alkalinization of Technetium-99m Sulfur Colloid Reduce Perceived Pain Levels During Non-breast Sentinel Lymphoscintigraphy?', 'orgStudyIdInfo': {'id': '31337'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'pH altered first', 'description': 'The first injection administered will be the pH altered solution. The second injection will be the standard of care solution (opposite order). The remaining injections will be randomly assigned as either standard of care or pH altered.', 'interventionNames': ['Drug: ph Altered first']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care first', 'description': 'The first injection administered will be the standard of care solution (SOC). The second injection will be the pH altered solution. The remaining injections will be randomly assigned as either standard of care or pH altered.', 'interventionNames': ['Drug: Standard of Care First']}], 'interventions': [{'name': 'Standard of Care First', 'type': 'DRUG', 'otherNames': ['Sodium Bicarbonate second'], 'description': 'For the second injection, and randomly after that, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to \\~7.40.', 'armGroupLabels': ['Standard of Care first']}, {'name': 'ph Altered first', 'type': 'DRUG', 'otherNames': ['Sodium Bicarbonate first'], 'description': 'For the first injection, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to \\~7.40. For the second injection, the standard of care will be given, and randomly after that either standard of care, or pH altered will be given.', 'armGroupLabels': ['pH altered first']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'UAMS', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'James A Ntambi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UAMS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'collaborators': [{'name': 'Howard J Barnhard, Resident Research Endowment.', 'class': 'UNKNOWN'}, {'name': 'UAMS DEPT of Radiology.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}