Spots Global Cancer Trial Database for Biodistribution and Dosimetry of 99mTc-Duramycin

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Trial Identification

Brief Title: Biodistribution and Dosimetry of 99mTc-Duramycin

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

Study ID: NCT05177640

Conditions

Healthy Volunteers

Interventions

99mTc-Duramycin

Study Description

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).