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NCT Number: NCT05177640

Biodistribution and Dosimetry of 99mTc-Duramycin

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Antwerp

Edegem, Antwerpen, 2650, Belgium

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

99mTc-Duramycin

Drug

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

Other names: cell death

Primary outcomes

  1. Determine the biodistribution of [99mTc]Duramycin.

    Time frame: 24 hours

    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.

  2. Determine the dosimetry evaluation of [99mTc]Duramycin.

    Time frame: 24 hours

    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.

Secondary outcomes

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

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Molecular Targeting Technologies, Inc.

Registry information

Official study title

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

Acronym: PicTURE

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 4, 2022
Registry last updated
Jan 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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