Biodistribution and Dosimetry of 99mTc-Duramycin
- Registration Number
- NCT05177640
- Lead Sponsor
- University Hospital, Antwerp
- Brief Summary
Conduct a first-in-human study in healthy volunteers to show safety, biodistribution and dosimetry of \[99mTc\]Duramycin.
- Detailed Description
Monocenter, prospective microdosing study in healthy volunteers. Healthy volunteers will undergo a \[99mTc\]Duramycin whole-body planar and abdominal SPECT scan at different time points after one iv injection of the radiotracer (1 h, 2h, 3h, 6h and 24h), while vital signs, urine and faces analysis will be checked. Blood samples will be taken at 12 different time points: 9 blood samples for dosimetry study and 3 blood samples will be subjected to clinical laboratory chemistry (renal and liver function chemistry, hematology, and blood coagulation parameters).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- Males (n=4) or females (n=4) age 18 years or older
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Ability to give study-specific written informed consent.
- Pregnant or lactating females (positive pregnancy test)
- Metal implants (e.g. pacemakers, osteosynthesis material)
- Body weight > 100 kg
- Severe claustrophobia
- Abnormal kidney or liver function tests
- Unable to comply with study requirements
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 99mTC-duramycin 99mTc-Duramycin single dose of 99mTc-duramycin in healthy volunteers who will undergo SPECT-CT scanning at different time points
- Primary Outcome Measures
Name Time Method Determine the biodistribution of [99mTc]Duramycin. 24 hours Subjects will be dosed with 99mTc-Duramycin at Time 0 on Day 0, and a SPECT scan will be conducted immediately after the injection. Imaging will be repeated at 1 hour, 2 hours, 3 hours, 6 hours and 24 hours after dosing.
All images generated will be reviewed for biodistribution.Determine the dosimetry evaluation of [99mTc]Duramycin. 24 hours Subjects will be dosed with 99mTc-Duramycin at Time 0 on Day 0, and a SPECT scan will be conducted immediately after the injection. Imaging will be repeated at 1 hour, 2 hours, 3 hours, 6 hours and 24 hours after dosing.
All images generated will be reviewed for dosimetry.
- Secondary Outcome Measures
Name Time Method Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" 72 hours
Trial Locations
- Locations (1)
University Hospital Antwerp
🇧🇪Edegem, Antwerpen, Belgium