[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07325253":3,"trial-entities:NCT07325253":83,"trial-summary:NCT07325253":87},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":14,"eligibility_criteria":50,"std_ages":54,"locations":57,"central_contacts":75,"overall_officials":77,"references":79,"see_also_links":80},"NCT07325253","2025-1051","A Pilot Study to Correlate 4-18F- Fluoro-1-naphthol 18F-4FN PET\u002FCT Imaging With Graft Versus Host Disease Manifestations","RECRUITING","2030-01-03","2026-09","2026-09-17","2025-11-18","M.D. Anderson Cancer Center","OTHER",false,"To study the safety and possible side effects of using the imaging agent 4-\\[18F\\]Fluoro-1-Naphthol (also called \\[18F\\]4FN) in PET\u002FCT scans for participants with chronic GVHD.","Primary Objective:\n\nDetermine the spatial and temporal correlation between \\[18F\\]4FN PET\u002FCT measurements and the clinical manifestations and severity of GVHD. We hypothesize that \\[18F\\]4FN PET\u002FCT imaging features will anatomically and by intensity (SUV) correlate with concurrent GVHD manifestations. We also hypothesize that PET\u002FCT imaging features will temporally precede GVHD manifestations at target anatomic locations.\n\nSecondary Objective:\n\nIdentify the \\[18F\\]4FN PET\u002FCT-positive GVHD lesions responsive to GVHD therapies. As a pharmacodynamic biomarker, we hypothesize that changes in \\[18F\\]4FN PET-positive GVHD lesions will correlate with treatments that target macrophages and neutrophils.",[18,19,20],"Pilot Study","PET\u002FCT Imaging","Host Disease Manifestation",[],"INTERVENTIONAL","DIAGNOSTIC",[25],"PHASE2",{"count":27,"type":28},16,"ESTIMATED",[30,37],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","[18F]-4FN","Given by IV",[35,36],"Part 1","Part 2",{"type":13,"name":38,"description":39,"armGroupLabels":40},"PET-CT","Imaging",[35,36],[42],{"measure":43,"description":44,"timeFrame":45},"Safety and adverse events (AEs).","Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0","Through study completion; an average of 1 year.",[],"ALL","18 Years",null,{"inclusion":51,"exclusion":52,"raw_text":53},[],[],"Eligibility Criteria\n\n1. Acute or Chronic GVHD - acute and chronic GVHD criteria can be found at (Harris, Young et al. 2016)(Jagasia, et al. 2015).\n2. Able to give written informed consent.\n3. ≥18 years of age\n4. Creatinine clearance ≥ 30 mL\u002Fmin\u002F1.73m2\n5. Subjects may be planned to receive a new systemic therapy for GVHD\n6. Prior \u002F continuing systemic therapy for acute or chronic GVHD is allowed\n7. KPS ≥ 20\n8. Ability to understand and the willingness to sign a written informed consent document.\n9. The effects of the study agent on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n   * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n   * History of hysterectomy or bilateral salpingo-oophorectomy.\n   * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n   * History of bilateral tubal ligation or another surgical sterilization procedure.\n\n     * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n10. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study agent administration.\n\nExclusion Criteria\n\n1. Unable to comply with all study procedures (for example, participants who are unable to come to all follow up visits because they live far away from the transplant center)\n2. Pregnant or lactating women: pregnant women are excluded from this study because the effects of \\[18F\\]4FN in pregnancy are not known.\n3. Subjects with contraindications to the use of \\[18F\\]4FN including confirmed allergy.\n4. Participants with a body weight of 400 pounds or more, or a body habitus which precludes their entry into the bore of the PET\u002FCT scanner, because the hardware is not intended to support that weight.\n5. Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance.\n6. Children below the age of 18 are excluded because of the unknown but potential risks of administration of radiopharmaceuticals to minors.",[55,56],"ADULT","OLDER_ADULT",[58],{"facility":59,"status":7,"city":60,"state":61,"zip":62,"country":63,"contacts":64,"geoPoint":72},"MD Anderson Cancer Center","Houston","Texas","77030","United States",[65,70],{"name":66,"role":67,"phone":68,"email":69},"George L Chen, MD","CONTACT","713-792-3630","glchen1@mdanderson.org",{"name":66,"role":71},"PRINCIPAL_INVESTIGATOR",{"lat":73,"lon":74},29.76328,-95.36327,[76],{"name":66,"role":67,"phone":68,"email":69},[78],{"name":66,"affiliation":12,"role":71},[],[81],{"label":59,"url":82},"http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":84,"biomarkers":86},[85],"Chronic Graft Versus Host Disease",[],{"nct_id":4,"found":88,"summary":89,"prompt_version":99},true,{"design":90,"status":91,"heading":92,"summary":93,"follow_up":94,"word_count":95,"commitments":96,"compensation":97,"drugs_mentioned":98},"This is an interventional pilot study with a planned enrollment of 16 participants. It is not specified if it is randomized or blinded.","completed","Pilot Study of 4-18F- Fluoro-1-naphthol PET\u002FCT for Chronic Graft Versus Host Disease","This study is looking at the safety and potential side effects of an imaging agent called 4-\\[18F\\]Fluoro-1-Naphthol (or \\[18F\\]4FN) when used with PET\u002FCT scans. This is for people who have chronic graft versus host disease (GVHD), a condition where donated cells attack the patient's body. Researchers want to see if the images from \\[18F\\]4FN PET\u002FCT can show where and how severe your chronic GVHD is, especially in your joints. They also want to see if these images can predict GVHD before symptoms appear. You can join if you are 18 or older, have chronic GVHD affecting your joints, and meet other health requirements. The study aims to see if this imaging method works as expected. The current recruitment status is unclear.","Safety and adverse events will be monitored through study completion, which is an average of 1 year.",121,"Participants will receive \\[18F\\]4FN by IV and undergo PET-CT imaging. The primary endpoint for safety will be measured through study completion, an average of 1 year.","Not stated in the trial record.",[],"v2"]