Biodistribution and Dosimetry of 99mTc-Duramycin

NCT05177640 | Completed Phase 1 FDA Drug

• 1 other identifier: NIH 1R01CA226531 - 01A1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

dosimetry, biodistribution, safety, 99mTc-duramycin

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0"

  72 hours

Study Arms (1)

99mTC-duramycin

EXPERIMENTAL

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

Drug: 99mTc-Duramycin

Interventions

99mTc-Duramycin DRUG

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

Also known as: cell death

99mTC-duramycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Molecular Targeting Technologies, Inc.: collaborator

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerpen, 2650, Belgium

Location

Related Publications (1)

• 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.

  PMID: 37646865 DERIVED

MeSH Terms

Interventions

technetium 99m HYNIC-duramycin; Cell Death

Intervention Hierarchy (Ancestors)

Cell Physiological Phenomena

Study Officials

• Sigrid Stroobants, prof

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: January 4, 2022
• Study Start: June 17, 2021
• Primary Completion: December 14, 2021
• Study Completion: December 14, 2021
• Last Updated: January 27, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)