None listed
Conditions
Brief summary
This study is investigating a new imaging method that may help doctors detect bacterial infections in the body. Current infection imaging approaches such as [¹8F]FDG-PET/CT and WBC scintigraphy are useful but have important limitations. [¹8F]FDG-PET/CT provides excellent sensitivity but poor specificity, as uptake is driven by glucose metabolism rather than pathogen-specific processes. WBC scintigraphy offers higher specificity but requires complex handling, longer procedures, and lower spatial resolution. A non-invasive, immune-targeted tracer that enables specific identification of infection remains an unmet medical need. The study uses an investigational imaging drug called [64Cu]IS1051. This drug is designed to attach to certain immune cells that are involved in bacterial infections, allowing the infection to be seen using PET/CT imaging. This is a first-in-human study, meaning this imaging drug has not previously been given to people. The information collected will help researchers determine whether this imaging approach should be studied further in future clinical research.
Interventions
[64Cu]IS1051is a novel, radioactive small-molecule ligand that binds specifically to LFA-1, a leukocyte surface integrin involved in immune-cell adhesion and migration. Radiolabelling with copper-64 (64Cu; half-life 12.7 h) results in the final injectable PET radiopharmaceutical investigational medical product (IMP) [64Cu]IS1051, to enable PET imaging over extended time windows.
This first-in-human (FIH) study will enrol adult participants who have undergone standard of care (SoC) diagnostic i
[64Cu]IS1051is a novel, radioactive small-molecule ligand that binds specifically to LFA-1, a leukocyte surface integrin involved in immune-cell adhesion and migration. Radiolabelling with copper-64 (64Cu; half-life 12.7 h) results in the final injectable PET radiopharmaceutical investigational medical product (IMP) [64Cu]IS1051, to enable PET imaging over extended time windows. This first-in-human (FIH) study will enrol adult participants who have undergone standard of care (SoC) diagnostic imaging (e.g., radiolabelled autologous White blood cell (WBC) imaging, or 67Ga-scintigraphy) with findings consistent with a suspected bacterial origin. This population represents patients with a high likelihood of bacterial infection, in whom improved diagnostic accuracy may directly impact clinical management and outcomes. Administration of [64Cu]IS1051: This study will involve a single administration of [64Cu]IS1051 within a defined diagnostic activity range. There is no randomization, blinding, or placebo control in this study. Details of the intervention are as follows: Procedures and/or processes used - Imaging Unit Dose Strength(s) - 150–300 MBq (4–8 mCi), <40 µg in <10 mL Duration of the intervention - 7 days Who will administer [64Cu]IS1051 - Principal Investigator Any strategies used to assess or monitor adherence to the intervention - Patient medical records, inpatient visit/monitoring Imaging Procedures: PET/CT imaging will be conducted at predefined timepoints following administration of [64Cu]IS1051 to assess biodistribution, dosimetry, and tracer kinetics (e.g., dynamic 0–30 minutes, static ~1 h, 3 h, 6 h, and 24 h post-injection). As this is a tracer-level radiopharmaceutical without pharmacologic activity, dose adjustment will be based on participant characteristics (e.g., age, sex, body weight) is not required according to protocol,
Sponsors
iSeek Biopharma AU Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age more than or equal to 18 years. 2. Able to provide written informed consent and comply with all study procedures. 3. Fluent in English, or an interpreter is available to ensure adequate understanding of the consent process and study participation. 4. Willing and able to undergo PET/CT imaging as scheduled. 5. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and pre-dosing and agree to use an effective method for at least 6 months after the last dose. Men with partners of childbearing potential must agree not to father a child or donate sperm for at least 3 months after the last dose of the study medication. 6. Clinically stable and suitable for imaging procedures at the time of enrolment. 7. Adequate renal and hepatic function based on recent (local SoC or screening) laboratory values within acceptable limits for study participation: estimated glomerular filtration rate (estimated glomerular filtration rate [eGFR] is more than or equal to 45 mL/min/1.73 m²; alanine aminotransferase/aspartate aminotransferase [ALT/AST] less than or equal to 3 × upper limit of normal [ULN]; total bilirubin less than or equal to 3 × ULN). 8. No contraindication to PET/CT scanning or intravenous injection (e.g. severe claustrophobia, inability to lie supine for approximately 60 minutes, or contrast allergy 9. Body weight less than or equal to 150 kg (to ensure scanner table and field-of-view compatibility). 10. Not participating in another investigational intervention study or research involving ionising radiation within 30 days prior to screening. 11. Clinically suspected infection associated with prosthetic material, implanted device, and/or bone, joint, or soft tissue involvement, supported by microbiological OR laboratory evidence (e.g. positive blood culture, elevated inflammatory markers, OR leukocytosis). 12. Positive imaging findings on ¹8F-FDG PET/CT, radiolabelled WBC scan, or 67Ga scintigraphy consistent with a bacterial infection
Exclusion criteria
1. Known active malignancy 2. Severe cardiopulmonary disease (e.g., New York Heart Association [NYHA] class IV heart failure, GOLD stage IV COPD) 3. Hemodynamic instability or uncontrolled systemic illness 4. Neutropenia (absolute neutrophil count [ANC] 450 ms (males) or >470 ms (females) 8. Any medical, psychiatric, or cognitive condition that may interfere with study compliance or increase risk, per investigator judgment 9. Scheduled administration of a diagnostic radiopharmaceutical within 48 hours before or after 64Cu-IS1051 imaging, by which such extra nuclear study may interfere with the [64Cu]IS1051 imaging study.
Outcome results
None listed