Metformin in Breast Cancer, Visualized With Positron Emission Tomography

NCT ID: NCT02882581

Last Updated: 2018-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

11C-metformin uptake in breast cancer. Single center, single dose, open-label.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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11C-metformin

All participants allocated to the study will be included in this arm

Group Type EXPERIMENTAL

11C-metformin

Intervention Type RADIATION

400MBq of 11C-metformin is injected in the cubital vein. The participant is then scanned for 120 min using Position Emission Tomography.

Interventions

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11C-metformin

400MBq of 11C-metformin is injected in the cubital vein. The participant is then scanned for 120 min using Position Emission Tomography.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* over 50 years
* C. mammae
* Tumor size: \> 10 mm in diameter
* Unilateral cancer
* WHO performance status 0-1

Exclusion Criteria

* Severe heart- or kidney failure
* Pregnant or breast feeding
* If the patient is found not eligible for participation in the study på principal investigator
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elias Immanuel Ordell Sundelin

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Niels Jessen, Prof,MD,PhD

Role: STUDY_DIRECTOR

Department of Clinical Pharmacology, Aarhus University Hospital

Elias IO Sundelin, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Medicine, Aarhus University Hospital

Locations

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Department of Nuclear Medicine & PET-center, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Department of Surgery, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2016-000132-18

Identifier Type: -

Identifier Source: org_study_id

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