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Metformin in Breast Cancer, Visualized With Positron Emission Tomography

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
11C-metformin
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring Metformin, Pharmacokinetics, Organic cation transporter, Multidrug and toxin extrusion, Pharmacogenetics, positron emission tomography

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

11C-metformin

Arm Description

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

Outcomes

Primary Outcome Measures

Metformin uptake in breast cancer

Secondary Outcome Measures

Full Information

First Posted
August 25, 2016
Last Updated
January 19, 2018
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02882581
Brief Title
Metformin in Breast Cancer, Visualized With Positron Emission Tomography
Official Title
Metformin in Breast Cancer, Visualized With Positron Emission Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Metformin, Pharmacokinetics, Organic cation transporter, Multidrug and toxin extrusion, Pharmacogenetics, positron emission tomography

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
11C-metformin uptake in breast cancer. Single center, single dose, open-label.
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
11C-metformin
Arm Type
Experimental
Arm Description
All participants allocated to the study will be included in this arm
Intervention Type
Radiation
Intervention Name(s)
11C-metformin
Intervention Description
400MBq of 11C-metformin is injected in the cubital vein. The participant is then scanned for 120 min using Position Emission Tomography.
Primary Outcome Measure Information:
Title
Metformin uptake in breast cancer
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Jessen, Prof,MD,PhD
Organizational Affiliation
Department of Clinical Pharmacology, Aarhus University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elias IO Sundelin, MD
Organizational Affiliation
Department of Clinical Medicine, Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nuclear Medicine & PET-center, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
DK-8000
Country
Denmark
Facility Name
Department of Surgery, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
DK-8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Metformin in Breast Cancer, Visualized With Positron Emission Tomography

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