Biodistribution and Dosimetry of 99mTc-Duramycin (PicTURE)

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: 99mTc-Duramycin

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • University Hospital Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: Molecular Targeting Technologies, Inc.
• Investigators: Principal Investigator: Sigrid Stroobants, prof, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2021
• Primary Completion (Actual): December 14, 2021
• Study Completion (Actual): December 14, 2021

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: dosimetry, biodistribution, safety, 99mTc-duramycin
• Other Study ID Numbers: NIH 1R01CA226531 - 01A1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes