Biodistribution and Dosimetry of 99mTc-Duramycin

Healthy Volunteers Clinical Trial

— PicTURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05177640
• Other study ID #: NIH 1R01CA226531 - 01A1
• Status: Completed
• Phase: Phase 1
• Start date: June 17, 2021
• Est. completion date: December 14, 2021

Study information

• Verified date: July 2021
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 14, 2021
• Est. primary completion date: December 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem	Antwerpen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Molecular Targeting Technologies, Inc.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0"		72 hours