NCT05177640

Biodistribution and Dosimetry of 99mTc-Duramycin

Early Prediction of Tumor Response to Treatment: Translation of 99mTc-Duramycin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	99mTc-Duramycin	This is a single dose study of 99mTc-duramycin in healthy volunteers who will undergo serial SPECT scanning

Timeline

• Start date: 2021-06-17
• Primary completion: 2021-12-14
• Completion: 2021-12-14
• First posted: 2022-01-04
• Last updated: 2022-01-27

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study