Breast CancerPhase 1NCT02882581
Metformin in Breast Cancer, Visualized With Positron Emission Tomography
A Phase 1 study testing 11C-metformin in people with Breast Cancer, run by Aarhus University Hospital at 2 sites in Denmark.
Trial summary
The general purpose of the trial is to investigate whether metformin is taken up into the breast tumor. Studies in the last few years have shown an effect of metformin on cell proliferation on breast cancer. It is though unclear whether the effect on tumor is direct, indirect or a combination of the two. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 11C-metformin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesDenmark
- Study dates
- Aug 2016to Oct 2017
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 50 years
- C. mammae
- Tumor size: > 10 mm in diameter
- Unilateral cancer
- WHO performance status 0-1
Who cannot join
- Severe heart- or kidney failure
- Pregnant or breast feeding
- If the patient is found not eligible for participation in the study på principal investigator
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Nuclear Medicine & PET-center, Aarhus University Hospital
Aarhus, DK-8000
Department of Surgery, Aarhus University Hospital
Aarhus, DK-8000
About this study
The general purpose of the trial is to investigate whether metformin is taken up into the breast tumor. Studies in the last few years have shown an effect of metformin on cell proliferation on breast cancer. It is though unclear whether the effect on tumor is direct, indirect or a combination of the two. The investigators plan to:
- investigate if metformin is taken up in breast cancer using our novel 11C-metformin tracer and positron emission tomography (PET)
- investigate whether the uptake is correlated to the amounts of organic cation transporters (OCT1-3, MATE 1 \&2 and PMAT) using quantitive polymerase chain reaction (qPCR).
- Conditions
- Breast Cancer
- Being tested
- 11C-metformin
- Keywords
- Metformin, Pharmacokinetics, Organic cation transporter, Multidrug and toxin extrusion, Pharmacogenetics, positron emission tomography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-metforminRadiation
400MBq of 11C-metformin is injected in the cubital vein. The participant is then scanned for 120 min using Position Emission Tomography.
| Study group | Role | What they receive |
|---|---|---|
| 11C-metformin | Experimental | All participants allocated to the study will be included in this arm Receives: Radiation: 11C-metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metformin uptake in breast cancer
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 11C-metformin uptake in breast cancer. Single center, single dose, open-label.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elias Immanuel Ordell Sundelin, Aarhus University Hospital
- Investigators
- Niels Jessen, Prof,MD,PhD, Study director, Department of Clinical Pharmacology, Aarhus University HospitalElias IO Sundelin, MD, Principal investigator, Department of Clinical Medicine, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882581
- Sponsor's protocol ID
- 2016-000132-18
- Other IDs
- 2016
- Status last verified
- Jan 2018
- First submitted
- 25 Aug 2016
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin in Breast Cancer, Visualized With Positron Emission Tomography
- ClinicalTrials.gov ID
- NCT02882581
- Acronym / sponsor ID
- 2016-000132-18
- Conditions
- Breast Cancer
- Keywords
- Metformin, Pharmacokinetics, Organic cation transporter, Multidrug and toxin extrusion, Pharmacogenetics, positron emission tomography
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 30 Aug 2016 (estimated)
- 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.
The general purpose of the trial is to investigate whether metformin is taken up into the breast tumor. Studies in the last few years have shown an effect of metformin on cell proliferation on breast cancer. It is though unclear whether the effect on tumor is direct, indirect or a combination of the two. The investigators plan to:
- investigate if metformin is taken up in breast cancer using our novel 11C-metformin tracer and positron emission tomography (PET)
- investigate whether the uptake is correlated to the amounts of organic cation transporters (OCT1-3, MATE 1 \&2 and PMAT) using quantitive polymerase chain reaction (qPCR).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 11C-metformin uptake in breast cancer. Single center, single dose, open-label.
| Arm | Type | Receives |
|---|---|---|
| 11C-metformin | Experimental | Radiation: 11C-metforminAll participants allocated to the study will be included in this arm |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- over 50 years
- C. mammae
- Tumor size: > 10 mm in diameter
- Unilateral cancer
- WHO performance status 0-1
Key exclusion criteria (3 listed)
- Severe heart- or kidney failure
- Pregnant or breast feeding
- If the patient is found not eligible for participation in the study på principal investigator
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 |
|---|---|---|
| 11C-metformin400MBq of 11C-metformin is injected in the cubital vein. The participant is then scanned for 120 min using Position Emission Tomography. | Radiation | 11C-metformin |
Primary outcome
Metformin uptake in breast cancer
Time frame: 12 months
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 23 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Niels Jessen, Prof,MD,PhD study director
Department of Clinical Pharmacology, Aarhus University Hospital
Elias IO Sundelin, MD principal investigator
Department of Clinical Medicine, Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 11C-metformin in people with Breast Cancer, run by Aarhus University Hospital at 2 sites in Denmark.
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 5 inclusion and 3 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 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Metformin uptake in breast cancer (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2018; AzTrials last refreshed its copy on 6 Nov 2026.