[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"radiation-fibrosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:radiation-fibrosis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100570554","impact-of-photobiomodulation-pbm-on-biomarkers-of-radiation-lymphedema-and-fibrosis-in-head-and-neck-cancer-patients-100570554",false,"NCT06708754","Impact of Photobiomodulation (PBM) on Biomarkers of Radiation Lymphedema and Fibrosis in Head and Neck Cancer Patients","PBM-LEF Study: The Impact of PBM on Biomarkers of Radiation Lymphedema and Fibrosis in Head and Neck Cancer Patients: A Feasibility Study","PBM-LEF","Inclusion Criteria:\n\n* Patients treated with radiation for head and neck cancer who are ≥ 3 months \\\u003C 36 months post-RT (last RT).\n* Patients who received at least 50Gy of bilateral neck RT. Subjects who received RT or concurrent chemoradiation (chemoRT) therapy for HNC are eligible.\n* No evidence of disease as documented by imaging 3 months after completion of RT.\n* Common Terminology Criteria for Adverse Events (CTCAE) fibrosis score ≥ 2 at enrollment.\n* Patient who has body mass index (BMI) \\>30 at the time of enrollment may be excluded at a discretion of the principal investigator if fibrotic areas cannot be identified by clinical objective assessment of fibrosis.\n* Willing to comply with all study procedures and be available for the duration of the study.\n\nExclusion Criteria:\n\n* Woman who are pregnant or planning to become pregnant or breast-feeding.\n* Patients enrolled on another drug or device investigational trial for prevention or treatment of LEF.\n* Patients deprived of freedom, under supervision or guardianship.\n* Patients unable to attend to scheduled visits due to geographical, social or mental reasons.\n* Patients who received prior PBM therapy for RT toxicities in the last year;\n* Patients who report being photosensitive.\n* Patients who have chronic immunosuppression or are on current immunosuppressive therapies.\n* Any patient who, in the opinion of the investigator, is unable or unlikely to comply fully with the study requirements or procedures for any reason.","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","Radiation fibrosis syndrome (RFS) is a general side effect of radiation therapy (RT) which can adversely impact patients chronically over years typically triggered by an acute inflammatory state that evolves into chronic inflammation and tissue remodeling causing lymphedema, fibrosis, pain, atrophy and organ dysfunction. Some of the side effects that encompass RFS in the head and neck (HNC) population include decreased ability to fully open the mouth (trismus), neck pain and tightness (cervical dystonia), lymphedema (swelling), difficult with speech and swallowing and salivary hypofunction. Although there is Level I evidence demonstrating the benefit of Photobiomodulation (PBM) therapy to prevent acute mucositis in HNC patients treated with RT, there is only limited data regarding its impact.\n\nThis is a clinical trial to compare active treatment (PBM-therapy) with sham control (Sham- therapy). Up to 60 patients will be randomized to the two groups with equal allocation to estimate the efficacy (soft tissue thickness) of external Photobiomodulation (PBM) with light-emitting diode (LED) planned therapy for the treatment of radiation fibrosis syndrome (RFS) in head and neck cancer (HNC) patients who have undergone radiation therapy (RT) compared with sham control.",[27,28,29],"Radiation Lymphedema","Radiation Fibrosis","Head and Neck Cancer","RECRUITING","2026-03-24",{"date":33,"type":34},"2026-03-30","ACTUAL",{"date":36,"type":34},"2025-02-13",{"date":38,"type":21},"2030-02-13",{"name":40,"class":41},"NYU Langone Health","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":42},"100399750","phase-2-evaluation-of-pet-probe-68gacbp8-in-the-detection-of-radiation-induced-tissue-injury-100399750","NCT04485286","Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury","Inclusion Criteria for lung cancer subjects:\n\n* Eligible patients will be those harboring locally advanced clinical stage I-III NSCLC who are not eligible for surgical resection, or those with stage IIIa NSCLC who are deemed candidates for multi-modality therapy, i.e. concurrent chemotherapy and radiation followed by pulmonary resection.\n* Age greater than 18 years\n* Have the ability to give written informed consent.\n* No tobacco use within the prior 6 months.\n\nInclusion Criteria for pancreatic cancer subjects:\n\n* Age ≥ 18 years.\n* Life expectancy of greater than 3 months.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Histologically or cytologically confirmed diagnosis of PDAC.\n* Tumor should be confirmed with imaging based on the standard-of-care baseline abdominal CT performed within 1 month before study visit 1.\n* Core samples for initial diagnosis must be available at the Department of Pathology at Massachusetts General Hospital.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational imaging and standard treatment regimen are eligible for this trial.\n* Scheduled study visit 1 within 1 month prior to starting neoadjuvant chemoradiotherapy (CRT)\n* Subjects undergo neoadjuvant chemotherapy followed by radiotherapy (CRT) as part of their standard clinical care and based on institutional standards.\n* Scheduled surgical pancreas resection within 1 month after post-CRT study visit.\n* Subjects are required to undergo pre-surgical CT of abdomen within 1 month after completion of standard neoadjuvant CRT as part of routine clinical work-up.\n\nExclusion Criteria for lung cancer subjects:\n\n* Electrical implants such as cardiac pacemaker or perfusion pump\n* Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing;\n* Pregnant or breastfeeding (a negative quantitative serum hCG pregnancy test is required for females having child-bearing potential before the subject can participate);\n* Claustrophobic reactions;\n* Research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);\n* Unable to lie comfortably on a bed inside the MR-PET;\n* Body weight of \\> 300 lbs (weight limit of the MRI table);\n* Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and\u002For during study procedures);\n* Known history of pulmonary disease (Except lung cancer or smoking related lung disease,)\n* Pneumonia or other acute respiratory illness within 6 weeks of study entry, pneumonia defined with elevated WBC, fever, infiltrate on CXR and need for antibiotics\n\nExclusion Criteria for pancreatic cancer subjects:\n\n* History of radiotherapy to the upper abdomen in the past.\n* History of reaction to MRI contrast (Gadoterate meglumine)\n* Clinical or imaging diagnosis of acute pancreatitis within 6 weeks prior to study visit\n* Participants with uncontrolled intercurrent illness or if determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening and\u002For during study).\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Electrical implants such as cardiac pacemaker or perfusion pump;\n* Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing;\n* eGFR of less than 30 mL\u002Fmin\u002F1.73 m2 within the past 90 days;\n* Pregnant or breastfeeding (a negative quantitative serum hCG pregnancy test is required for females having child-bearing potential at each PET\u002FMRI study visit;\n* Claustrophobic reactions;\n* Research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);\n* Unable to lie comfortably on a bed inside the MR-PET;\n* BMI \\> 33 (limit of the PET-MRI table)","80 Years",{"count":51,"type":21},72,[53],"PHASE2","The goal of this study is to investigate the efficacy of \\[68Ga\\]CBP8 to detect collagen deposition in radiation induced tissue injury.",[56,28,57,58],"Lung Cancer","Radiation Induced Lung Injury","Pancreas Cancer",[60,61],"fibrosis","positron emission tomography","2026-02-25",{"date":64,"type":34},"2026-02-27",{"date":66,"type":34},"2020-07-19",{"date":68,"type":21},"2027-07",{"name":70,"class":41},"Massachusetts General Hospital"]