Biodistribution and Dosimetry of 99mTc-Duramycin

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

Detailed Description
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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).

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: 99mTc-Duramycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 99mTC-duramycin<br>single dose of 99mTc-duramycin in healthy volunteers who will undergo SPECT-CT scanning at different time points | Drug: 99mTc-Duramycin<br>* This is a single dose study of 99mTc-duramycin in healthy volunteers who will undergo serial SPECT scanning<br>* Other names: cell death;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the biodistribution of [99mTc]Duramycin. | 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. | 24 hours | 
| Determine the dosimetry evaluation of [99mTc]Duramycin. | 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. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |  | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dosimetry, biodistribution, safety, 99mTc-duramycin