Biodistribution and Dosimetry of 99mTc-Duramycin

NCT ID: NCT05177640

Last Updated: 2022-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-17
• Study Completion Date: 2021-12-14

Brief Summary

Conduct a first-in-human study in healthy volunteers to show safety, biodistribution and dosimetry of [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).

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

99mTC-duramycin

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

Group Type: EXPERIMENTAL

99mTc-Duramycin

Intervention Type: DRUG

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

Interventions

99mTc-Duramycin

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

Intervention Type: DRUG

Other Intervention Names

cell death

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Molecular Targeting Technologies, Inc.

INDUSTRY

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sigrid Stroobants, prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

University Hospital Antwerp

Edegem, Antwerpen, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 37646865 (View on PubMed)

Other Identifiers

NIH 1R01CA226531 - 01A1

Identifier Type: -

Identifier Source: org_study_id