Biodistribution and Dosimetry of 99mTc-Duramycin (PicTURE)

Antwerp University Hospital (UZA)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: 99mTc-Duramycin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05177640

NIH 1R01CA226531 - 01A1

Details and patient eligibility

About

Conduct a first-in-human study in healthy volunteers to show safety, biodistribution and dosimetry of [99mTc]Duramycin.

Full 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).

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

99mTC-duramycin

Experimental group

Description:

single dose of 99mTc-duramycin in healthy volunteers who will undergo SPECT-CT scanning at different time points

Treatment:

Drug: 99mTc-Duramycin