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| Name | Class |
|---|---|
| Molecular Targeting Technologies, Inc. | INDUSTRY |
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Conduct a first-in-human study in healthy volunteers to show safety, biodistribution and dosimetry of [99mTc]Duramycin.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 99mTC-duramycin | Experimental | single dose of 99mTc-duramycin in healthy volunteers who will undergo SPECT-CT scanning at different time points |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 99mTc-Duramycin | Drug | This is a single dose study of 99mTc-duramycin in healthy volunteers who will undergo serial SPECT scanning |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sigrid Stroobants, prof | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Antwerp | Edegem | Antwerpen | 2650 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37646865 | Derived | Metelerkamp 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 9, 2025 | |
| Reset | Apr 29, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 9, 2025 | Apr 29, 2025 |
| ID | Term |
|---|---|
| C578182 | technetium 99m HYNIC-duramycin |
| D016923 | Cell Death |
| ID | Term |
|---|---|
| D002468 | Cell Physiological Phenomena |
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