[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06199713":3,"trial-entities:NCT06199713":131,"trial-summary:NCT06199713":134},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":27,"primary_purpose":15,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":41,"secondary_outcomes":55,"sex":85,"minimum_age":86,"maximum_age":15,"healthy_volunteers":87,"eligibility_criteria":88,"std_ages":102,"locations":105,"central_contacts":121,"overall_officials":127,"references":129,"see_also_links":130},"NCT06199713","2023-1089","Correlating Early FDG PET\u002FCT and ctDNA in Immune Checkpoint Inhibitor (ICI)-Treated Melanoma Patients","Correlation Between Early Interval 18F-Fluorodeoxyglucose Positron Emission Tomography\u002FComputed Tomography (PET\u002FCT) and Circulating Tumor DNA (ctDNA) in Advanced Melanoma Patients Treated With Immune Checkpoint Inhibitors","RECRUITING","2029-01","2026-01","2026-01-20","2024-01-30","University of Wisconsin, Madison","OTHER",null,"The purpose of this research study is to determine if analysis of PET\u002FCT scans and testing of blood samples in people with melanoma that has spread in their body can help researchers determine which patients are more or less likely to respond to immunotherapy and are more or less likely to have side effects. 24 participants will be enrolled and be on study until approximately 4 weeks after their first dose of Immune Checkpoint Inhibitor therapy.","This is a pilot, prospective, observational study to estimate the degree to which baseline and early interval 18F-FDG PET\u002FCT imaging within 3-4 weeks of ICI therapy initiation can accurately correlate with ctDNA level trends, predict clinical response, onset of immune-related adverse events, and survival outcomes in advanced stage melanoma patients.\n\nPrimary Objective\n\n• To determine if early interval response assessment with 18F-FDG PET\u002FCT during initial treatment with ICI therapy at 3-4 weeks correlates with ctDNA level changes in advanced melanoma patients.\n\nSecondary Objectives\n\n* To determine if early interval response assessment with 18F-FDG PET\u002FCT during initial treatment with ICI therapy at 3-4 weeks predicts clinical efficacy at standard disease assessment time points in advanced melanoma patients.\n* To assess if early interval response assessment with 18F-FDG PET\u002FCT predicts development of clinical irAEs in advanced melanoma patients.\n* To assess if early interval response assessment with 18F-FDG PET\u002FCT and ctDNA level predicts progression-free survival (PFS) in advanced melanoma patients.\n* To assess if early interval response assessment with 18F-FDG PET\u002FCT and ctDNA level predicts overall survival (OS) in advanced melanoma patients.",[19,20,21,22],"Melanoma","Melanoma Stage III","Melanoma Stage IV","Unresectable Melanoma",[24,25,26],"circulating tumor DNA","FDG","ICI","OBSERVATIONAL",[],{"count":30,"type":31},24,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"DIAGNOSTIC_TEST","18F-Fluorodeoxyglucose Positron Emission Tomography\u002FComputed Tomography","research scan 3-4 weeks after start of immunotherapy",[38],"Advanced Melanoma Patients with Immune Checkpoint Inhibitors",[40],"18F-FDG PET\u002FCT",[42,46,49,52],{"measure":43,"description":44,"timeFrame":45},"Change in ctDNA level from baseline to 3-4 week after the start of therapy","ctDNA level is monitored per standard of care in this population, data from chart review.","baseline to 3-4 weeks after start of therapy (up to 5 weeks on study)",{"measure":47,"description":48,"timeFrame":45},"Change in 18F-FDG PET\u002FCT response from baseline to 3-4 week after the start of therapy","Lesion-level and patient-level 18F-FDG PET\u002FCT response assessment at baseline and at 3-4 weeks after starting ICI therapy reported as SUV max.",{"measure":50,"description":51,"timeFrame":45},"Correlation between ctDNA level change and 18F-FDG PET\u002FCT response from baseline to 3-4 week after the start of therapy","Correlate lesion-level and patient-level 18F-FDG PET\u002FCT response assessment at baseline and at 3-4 weeks after starting ICI therapy with quantitative changes in ctDNA levels at baseline and at 3-4 weeks after starting ICI therapy. Pearson's or Rank's correlation coefficient will be used to measure the baseline measures for ctDNA level trends and PET\u002FCT responses and for those measurements at 3-4 weeks.",{"measure":53,"description":54,"timeFrame":45},"Diagnostic Accuracy of ctDNA level trend and PET\u002FCT imaging for predicting growth inhibition as measured by Area under the Curve","Receiver-operator curve analysis will be performed to determine the diagnostic accuracy of ctDNA level trend and PET\u002FCT imaging for predicting growth inhibition (area under the curve).",[56,60,63,66,70,73,76,79,82],{"measure":57,"description":58,"timeFrame":59},"Objective Response Rate (ORR)","Correlate lesion-level and patient-level 18F-FDG PET\u002FCT treatment response assessment at baseline and at 3-4 weeks after starting ICI therapy with clinical response evaluations (RECIST, PERCIST, PECRIT, iRECIST, irRECIST) at 3, 6, 9, and 12 months after the first ICI dose. ORR is Partial Response (PR) plus Complete Response (CR).","up to 12 months after the first ICI dose (approximately 1 year on study)",{"measure":61,"description":62,"timeFrame":59},"Disease Control Rate (DCR)","Correlate lesion-level and patient-level 18F-FDG PET\u002FCT treatment response assessment at baseline and at 3-4 weeks after starting ICI therapy with clinical response evaluations (RECIST, PERCIST, PECRIT, iRECIST, irRECIST) at 3, 6, 9, and 12 months after the first ICI dose. DCR is Stable Disease (SD) plus PR plus CR.",{"measure":64,"description":65,"timeFrame":59},"Change in Standard Uptake Value (SUV) metrics with onset of Immune Related Adverse Events (irAE)","Correlate organ-level FDG uptake and changes from the baseline and early 18F-FDG PET\u002FCT assessment with onset of first, second, and third symptomatic irAE per CTCAE v5.0",{"measure":67,"description":68,"timeFrame":69},"Progression Free Survival (PFS)","PFS will be summarized using Kaplan-Meier estimates of the median survival times. Point estimates as well as 95% confidence intervals will be provided","up to 3 years after the first ICI dose (approximately 3 years on study)",{"measure":71,"description":72,"timeFrame":69},"Correlation Coefficient for 18F-FDG PET\u002FCT response at 3-4 weeks after the start of therapy and PFS","Correlate early 18F-FDG PET\u002FCT treatment response with Progression Free Survival (PFS) as measured from the date of initiation of ICI treatment until the criteria for disease progression is met as defined by RECIST, PECRIT, or death occurs.",{"measure":74,"description":75,"timeFrame":69},"Correlation Coefficient for ctDNA level at 3-4 weeks after the start of therapy and PFS","Correlate early ctDNA level trends with Progression Free Survival (PFS) as measured from the date of initiation of ICI treatment until the criteria for disease progression is met as defined by RECIST, PECRIT, or death occurs.",{"measure":77,"description":78,"timeFrame":69},"Overall Survival (OS)","OS will be summarized using Kaplan-Meier estimates of the median survival times. Point estimates as well as 95% confidence intervals will be provided",{"measure":80,"description":81,"timeFrame":69},"Correlation Coefficient for 18F-FDG PET\u002FCT response at 3-4 weeks after the start of therapy and OS","Correlate early 18F-FDG PET\u002FCT response assessment with Overall Survival (OS) as measured from the date of initiation of ICI treatment until date of death from any cause.",{"measure":83,"description":84,"timeFrame":69},"Correlation Coefficient for ctDNA level at 3-4 weeks after the start of therapy and OS","Correlate early ctDNA level trends with Overall Survival (OS) as measured from the date of initiation of ICI treatment until date of death from any cause.","ALL","18 Years",false,{"inclusion":89,"exclusion":96,"raw_text":101},[90,91,92,93,94,95],"Willing to provide informed consent.","Must have an advanced stage III or stage IV melanoma diagnosis for which treatment with ipilimumab, nivolumab, and\u002For pembrolizumab, either alone or in combination with other ICI therapy, is planned.","Must be planning to participate in Signatera™ (ctDNA level) monitoring with standard of care laboratory testing routinely obtained for treatment with ICI therapy.","Individuals at least 18 years of age.","Women of childbearing potential must be willing to use effective contraception as discussed with their oncologist while participating in this study.","Willing to comply with all study procedures and be available for the duration of the study.",[97,98,99,100],"Not able to receive treatment with ICI therapy","Use of investigational drugs, biologics, or devices within 30 days prior to enrollment.","Women who are pregnant, lactating, or planning on becoming pregnant during the study.","Not suitable for study participation due to other reasons at the discretion of the investigators.","Inclusion Criteria:\n\n* Willing to provide informed consent.\n* Must have an advanced stage III or stage IV melanoma diagnosis for which treatment with ipilimumab, nivolumab, and\u002For pembrolizumab, either alone or in combination with other ICI therapy, is planned.\n* Must be planning to participate in Signatera™ (ctDNA level) monitoring with standard of care laboratory testing routinely obtained for treatment with ICI therapy.\n* Individuals at least 18 years of age.\n* Women of childbearing potential must be willing to use effective contraception as discussed with their oncologist while participating in this study.\n* Willing to comply with all study procedures and be available for the duration of the study.\n\nExclusion Criteria:\n\n* Not able to receive treatment with ICI therapy\n* Use of investigational drugs, biologics, or devices within 30 days prior to enrollment.\n* Women who are pregnant, lactating, or planning on becoming pregnant during the study.\n* Not suitable for study participation due to other reasons at the discretion of the investigators.",[103,104],"ADULT","OLDER_ADULT",[106],{"facility":107,"status":8,"city":108,"state":109,"zip":110,"country":111,"contacts":112,"geoPoint":118},"University of Wisconsin Hospitals and Clinics (UWHC)","Madison","Wisconsin","53792","United States",[113,116],{"name":114,"role":115},"Steve Cho, MD","PRINCIPAL_INVESTIGATOR",{"name":117,"role":115},"Vincent Ma, MD",{"lat":119,"lon":120},43.07305,-89.40123,[122],{"name":123,"role":124,"phone":125,"email":126},"Cancer Connect","CONTACT","800-622-8922","clinicaltrials@cancer.wisc.edu",[128],{"name":117,"affiliation":13,"role":115},[],[],{"nct_id":4,"conditions":132,"biomarkers":133},[19],[],{"nct_id":4,"found":135,"summary":136,"prompt_version":146},true,{"design":137,"status":138,"heading":139,"summary":140,"follow_up":141,"word_count":142,"commitments":143,"compensation":144,"drugs_mentioned":145},"This is a pilot, observational study with 24 participants. It is designed to look at information from tests you would already be having.","completed","Observational Study for Melanoma Patients on Immunotherapy","This research study aims to understand how well early tests can predict if immunotherapy will work for people with advanced melanoma (skin cancer that has spread). Researchers will look at results from PET\u002FCT scans (a type of imaging test) and blood tests (called ctDNA level monitoring) taken 3-4 weeks after you start immunotherapy with ipilimumab, nivolumab, and\u002For pembrolizumab. The goal is to see if changes in these tests can predict how well you respond to treatment, if you might experience side effects, and how long you might live. This study plans to enroll 24 participants and will follow you for about 4 weeks after your first immunotherapy dose. You can join if you are 18 or older, have advanced melanoma, and are planning to receive these specific immunotherapies.","You will be on study for up to 5 weeks after the start of therapy.",128,"You would have a research PET\u002FCT scan 3-4 weeks after starting immunotherapy. Blood samples for ctDNA level monitoring will also be collected at baseline and 3-4 weeks after starting therapy.","Not stated in the trial record.",[],"v2"]