Clinical trial · Interventional
Biodistribution and Dosimetry of 99mTc-Duramycin
Early Prediction of Tumor Response to Treatment: Translation of 99mTc-Duramycin
NCT05177640CI-TRIAL-00056199PicTUREcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Conduct a first-in-human study in healthy volunteers to show safety, biodistribution and dosimetry of \[99mTc\]Duramycin.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy Volunteers | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 99mTc-Duramycin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 99mTC-duramycin
- description
- single dose of 99mTc-duramycin in healthy volunteers who will undergo SPECT-CT scanning at different time points
- interventionNames
- Drug: 99mTc-Duramycin
Primary outcomes (2)
- measure
- Determine the biodistribution of [99mTc]Duramycin.
- timeFrame
- 24 hours
- description
- 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.
- measure
- Determine the dosimetry evaluation of [99mTc]Duramycin.
- timeFrame
- 24 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDMetelerkamp Cappenberg T, De Schepper S, Vangestel C, De Lombaerde S, Wyffels L, Van den Wyngaert T, Mattis J, Gray B, Pak K, Stroobants S, Elvas F. First-in-human study of a novel cell death tracer [99mTc]Tc-Duramycin: safety, biodistribution and radiation dosimetry in healthy volunteers. EJNMMI Radiopharm Chem. 2023 Aug 30;8(1):20. doi: 10.1186/s41181-023-00207-1. PMID 37646865