Healthy VolunteersPhase 1PicTURENCT05177640
Biodistribution and Dosimetry of 99mTc-Duramycin
A Phase 1 study testing 99mTc-Duramycin in people with Healthy Volunteers, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
Conduct a first-in-human study in healthy volunteers to show safety, biodistribution and dosimetry of [99mTc]Duramycin. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- 99mTc-Duramycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Jun 2021to 14 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- 99mTc-Duramycin
- Keywords
- dosimetry, biodistribution, safety, 99mTc-duramycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-DuramycinDrug
Also called cell death
This is a single dose study of 99mTc-duramycin in healthy volunteers who will undergo serial SPECT scanning
| Study group | Role | What they receive |
|---|---|---|
| 99mTC-duramycin | Experimental | single dose of 99mTc-duramycin in healthy volunteers who will undergo SPECT-CT scanning at different time points Receives: Drug: 99mTc-Duramycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 hours
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0"
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start17 Jun 2021
- Primary completion14 Dec 2021
- Study completion14 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Molecular Targeting Technologies, Inc.
- Responsible party
- Sponsor
- Investigators
- Sigrid Stroobants, prof, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177640
- Sponsor's protocol ID
- NIH 1R01CA226531 - 01A1
- Acronym
- PicTURE
- Status last verified
- Jul 2021
- First submitted
- 15 Jul 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37646865
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Prediction of Tumor Response to Treatment: Translation of 99mTc-Duramycin
- ClinicalTrials.gov ID
- NCT05177640
- Acronym / sponsor ID
- PicTURE / NIH 1R01CA226531 - 01A1
- Conditions
- Healthy Volunteers
- Keywords
- dosimetry, biodistribution, safety, 99mTc-duramycin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Molecular Targeting Technologies, Inc.
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 99mTC-duramycin | Experimental | Drug: 99mTc-Duramycinsingle dose of 99mTc-duramycin in healthy volunteers who will undergo SPECT-CT scanning at different time points |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 99mTc-DuramycinAlso: cell deathThis is a single dose study of 99mTc-duramycin in healthy volunteers who will undergo serial SPECT scanning | Drug | 99mTC-duramycin |
Primary outcome
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.
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.
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0"
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Derived from this study: PubMed 37646865Metelerkamp 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.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sigrid Stroobants, prof principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 99mTc-Duramycin in people with Healthy Volunteers, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the biodistribution of [99mTc]Duramycin. (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05177640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.