[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07733674":3,"trial-entities:NCT07733674":110,"trial-summary:NCT07733674":115},{"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":21,"study_type":39,"primary_purpose":40,"phases":41,"enrollment_info":43,"interventions":46,"primary_outcomes":57,"secondary_outcomes":66,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":15,"eligibility_criteria":70,"std_ages":74,"locations":77,"central_contacts":98,"overall_officials":107,"references":108,"see_also_links":109},"NCT07733674","RMX-VH-02","Phase I Study of 203Pb-RMX-VH-PIB Dosimetry and Biodistribution in Patients With Solid Tumors Like GBM and PDAC","Dosimetry and Bio-distribution of 203Pb-RMX-VH-PIB in Newly Diagnosed or Recurrent Patients With Solid Tumors: A Phase I Exploratory Study","RECRUITING","2027-06-30","2026-07","2026-07-29","2026-08-15","Radiomedix, Inc.","INDUSTRY",false,"The goal of this Phase I clinical trial is to evaluate how the imaging drug 203Pb- RMX-VH-PIB distributes in the body and how much radiation different organs receive in patients with glioblastoma multiforme (GBM) or pancreatic ductal adenocarcinoma (PDAC).\n\nThe main questions it aims to answer are:\n\nHow does 203Pb-RMX-VH-PIB spread in the body (biodistribution)? What is the radiation dose delivered to organs (dosimetry)?\n\nParticipants will:\n\nReceive a single IV injection of 203Pb-RMX-VH-PIB. Undergo multiple SPECT\u002FCT imaging scans. Have blood, urine, vital signs, and ECG monitored for safety. Be followed for any side effects for up to 30 days.","This is an early-stage clinical trial designed to test a new imaging drug called 203Pb-RMX-VH-PIB. The study will use SPECT\u002FCT scans to see how the drug spreads through the body and how much radiation is delivered to different organs. The trial will enroll 20 patients who have either glioblastoma multiforme (GBM), an aggressive brain tumor, or pancreatic ductal adenocarcinoma (PDAC), a type of pancreatic cancer. Patients may be newly diagnosed, have recurrent disease, or have stable tumors. For GBM patients, the drug's distribution will be compared with MRI scans to see if it highlights the tumor areas effectively. For PDAC patients, the study will track how the drug behaves in pancreatic tumors. Participants will be divided into four groups to study both biodistribution and dosimetry in each cancer type. Each participant will receive a single intravenous injection of the drug, followed by several whole-body SPECT\u002FCT scans. To ensure safety, vital signs will be measured before and after the injection, and blood and urine samples will be collected at multiple time points. A 12-lead ECG will also be performed to monitor heart rhythm, and results will be reviewed by the investigator. Any side effects or health changes will be closely monitored and recorded for 30 days after administration. The goal of this exploratory study is to better understand how 203Pb-RMXVH- PIB works in the body and to gather important safety and radiation data in patients with GBM and PDAC.",[19,20],"Glioblastoma Multiforme (GBM)","Pancreatic Ductal Adenocarcinoma (PDAC)",[19,20,22,23,24,25,26,5,27,28,29,30,31,32,33,34,35,36,37,38],"203Pb-RMX-VH-PIB","SPECT\u002FCT Imaging","Brain Tumor","Radiopharmaceutical","Pancreatic Cancer","lead-203","radiolabeled peptide","investigational radiopharmaceutical","diagnostic radiopharmaceutical","tumor-targeted radiopharmaceutical","malignant glioma","high-grade glioma","malignant brain tumor","astrocytoma","IDH-wildtype glioblastoma","brain tumor targeting","Astrocytoma grad IV","INTERVENTIONAL","DIAGNOSTIC",[42],"PHASE1",{"count":44,"type":45},20,"ESTIMATED",[47,53],{"type":48,"name":49,"description":50,"armGroupLabels":51},"DRUG","203Pb-RMX-VHPIB injection","A single intravenous (IV) injection of the investigational radiopharmaceutical 203Pb-RMX-VHPIB administered to eligible patients.",[52],"203Pb-RMX-VH-PIB Imaging",{"type":54,"name":23,"description":55,"armGroupLabels":56},"DIAGNOSTIC_TEST","Serial whole-body and region-specific SPECT\u002FCT scans performed after IP administration to assess biodistribution and dosimetry",[52],[58,62],{"measure":59,"description":60,"timeFrame":61},"Whole-body and organ-specific absorbed radiation dose for 203Pb-RMX-VH-PIB","Whole-body and organ-specific absorbed radiation doses will be estimated using serial quantitative SPECT\u002FCT imaging and available blood and urine radioactivity data following a single intravenous administration of 203Pb-RMX-VH-PIB. Absorbed radiation doses will be summarized per unit of administered activity, such as mGy\u002FMBq.","From injection to up to 144 hours post-injection, multi-time-point SPECT\u002FCT, e.g., ~1-2 h, 4-6 h, 24 h, 48 h, 120 h, 144h (conditional).",{"measure":63,"description":64,"timeFrame":65},"Organ-Specific Absorbed Dose of 203Pb-RMX-VH-PIB","For each subject, VOIs are drawn over critical organs (e.g., kidneys, liver, spleen, red marrow, pancreas, brain, thyroid, salivary glands) and target lesions. Time-activity curves are fit and residence times derived; absorbed dose per injected activity is computed with a standard MIRD schema (e.g., OLINDA\u002FEXM or equivalent)","From injection to up to 72 hours post-injection (multi-time-point SPECT\u002FCT, e.g., ~1-2 h, 4-6h, 24 h, 48 h, 120h, 144h conditional)",[],"ALL","18 Years",null,{"inclusion":71,"exclusion":72,"raw_text":73},[],[],"Inclusion Criteria:\n\n1. Signed informed consent.\n2. Subjects aged ≥18 years.\n3. Karnofsky status ≥60.\n4. Negative urine pregnancy test in women of childbearing potential.\n5. Histologically confirmed and \u002For highly suspicious GBM (Adult type Astrocytoma grade IV both IDH-Mutant and IDH-Wild Type) including primary, recurrent or stable enhancing residual or primary, recurrent or stable enhancing residual PDAC.\n\n   a. GBM group i. Contrast enhanced Brain MRI image with results compatible with GBM within the 2 weeks of dosing day.\n\n   ii. Tumor size of ≥ 1.0 cm in any dimension by MRI. iii. No antiangiogenic therapy within 4 weeks of the day of dosing. iv. No chemotherapy within 2 weeks of the day of dosing. v. Subjects receiving corticosteroids must be on a stable or decreasing dose regimen prior to enrollment b. PDAC group i. No chemotherapy within 2 weeks of the day of dosing ii. Tumor size of ≥ 1.0 cm in any dimension by MRI or CT\n6. Recent blood test results (within 4 weeks pre-dose) as follows:\n\n   1. WBC: ≥ 2 x 109\u002FL\n   2. Haemoglobin: ≥ 8 g\u002FdL\n   3. Platelets: ≥75 x 109\u002FL\n   4. ALT, AST, AP ≤ 5 times ULN\n   5. Bilirubin: ≤ 2 times ULN\n   6. Creatinine clearance ≥ 60 mL\u002Fmin, calculated by the Cockcroft-Gault equation\n\nExclusion Criteria:\n\n1. Known hypersensitivity to RMX-VH peptide analogue, 203Pb-RMX-VH-PIB, 203Pb (Lead) , or any of the excipients of 203Pb-RMX-VH-PIB.\n2. Inability to undergo MRI or CT\u002FSPECT\u002FCT scans\n3. Current somatic or psychiatric disease\u002Fcondition that may interfere with consent or the objectives and assessments of the study.\n4. Pregnancy or plans to conceive during the course of study participation.\n5. In GBM groups participants requiring MRI: History of hypersensitivity or contraindication to gadolinium-based contrast agents, including prior allergic or anaphylactoid reactions to gadolinium contrast media, or any condition (e.g., severe renal impairment, acute kidney injury) that, in the investigator's judgment, increases the risk associated with gadolinium administration.\n6. In PDAC groups participants requiring CT scans: Any contraindications to iodinated contrast agents include a history of severe hypersensitivity or allergic reaction to iodinated contrast media, significant renal impairment (e.g., eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² or acute kidney injury), uncontrolled hyperthyroidism or other thyroid disorders that may worsen with iodine exposure, prior contrast-induced nephropathy, pregnancy, and any unstable medical condition such as severe heart failure or hemodynamic instability that, in the investigator's judgment, increases the risk of contrast administration.\n7. Male and female participants of childbearing potential who are unwilling or unable to use an acceptable method of contraception for the duration of the study.\n8. Women who are breastfeeding\n9. Participants who are currently receiving treatment with statins (HMG-CoA reductase inhibitors), including but not limited to atorvastatin, rosuvastatin, pitavastatin, simvastatin, lovastatin, pravastatin, or fluvastatin, are excluded unless the medication has been discontinued for at least four (4) drug half-lives prior to administration of the investigational product",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":79,"status":8,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":95},"Excel Diagnostics & Nuclear Oncology Center","Houston","Texas","77042","United States",[85,91],{"name":86,"role":87,"phone":88,"phoneExt":89,"email":90},"Susan Cork","CONTACT","713-781-6200","3203","scork@exceldiagnostics.com",{"name":92,"role":87,"phone":88,"phoneExt":93,"email":94},"Nereyda Sauceda Sauceda","3246","nsauceda@exceldiagnostics.com",{"lat":96,"lon":97},29.76328,-95.36327,[99,103],{"name":100,"role":87,"phone":101,"email":102},"Ebrahim Delpassand, MD, FACNM","713-499-9733","edelpassand@radiomedix.com",{"name":104,"role":87,"phone":105,"email":106},"Izabela Tworowska, MS Pharm Clinical, Ph.D","832-868-2812","itworowska@radiomedix.com",[],[],[],{"nct_id":4,"conditions":111,"biomarkers":114},[112,113],"Glioblastoma","Pancreatic Ductal Adenocarcinoma",[],{"nct_id":4,"found":116,"summary":117,"prompt_version":127},true,{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This is an early-stage, interventional study with a planned enrollment of 20 participants. It is not specified if it is randomized or blinded.","completed","Phase I Study of 203Pb-RMX-VH-PIB for Glioblastoma and Pancreatic Cancer Imaging","This early-stage study is looking at an imaging drug called 203Pb-RMX-VH-PIB. It aims to understand how this drug spreads throughout the body (biodistribution) and how much radiation different organs receive (dosimetry) in people with glioblastoma multiforme (GBM), a type of brain tumor, or pancreatic ductal adenocarcinoma (PDAC), a type of pancreatic cancer. You would receive a single injection of 203Pb-RMX-VH-PIB and have several SPECT\u002FCT imaging scans. The study is looking for 20 participants aged 18 or older with these specific cancer types. The main goal is to see how the drug moves through the body and the radiation dose it delivers to organs.","You will be followed for any side effects for up to 30 days after the injection.",103,"You would receive a single intravenous injection of 203Pb-RMX-VH-PIB and undergo multiple SPECT\u002FCT imaging scans. You would also have blood, urine, vital signs, and ECG monitored.","Not stated in the trial record.",[23],"v2"]