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Trial record 35 of 228 for:    metformin and cancer AND Hypoglycemic

Metformin in Breast Cancer, Visualized With Positron Emission Tomography

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ClinicalTrials.gov Identifier: NCT02882581
Recruitment Status : Completed
First Posted : August 30, 2016
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Elias Immanuel Ordell Sundelin, Aarhus University Hospital

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).

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: 11C-metformin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 11C-metformin uptake in breast cancer. Single center, single dose, open-label.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Metformin in Breast Cancer, Visualized With Positron Emission Tomography
Study Start Date : August 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 11C-metformin
All participants allocated to the study will be included in this arm
Radiation: 11C-metformin
400MBq of 11C-metformin is injected in the cubital vein. The participant is then scanned for 120 min using Position Emission Tomography.




Primary Outcome Measures :
  1. Metformin uptake in breast cancer [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02882581


Locations
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Denmark
Department of Nuclear Medicine & PET-center, Aarhus University Hospital
Aarhus, Denmark, DK-8000
Department of Surgery, Aarhus University Hospital
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
Aarhus University Hospital
Investigators
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Study Director: Niels Jessen, Prof,MD,PhD Department of Clinical Pharmacology, Aarhus University Hospital
Principal Investigator: Elias IO Sundelin, MD Department of Clinical Medicine, Aarhus University Hospital

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Responsible Party: Elias Immanuel Ordell Sundelin, MD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02882581     History of Changes
Other Study ID Numbers: 2016-000132-18
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Elias Immanuel Ordell Sundelin, Aarhus University Hospital:
Metformin
Pharmacokinetics
Organic cation transporter
Multidrug and toxin extrusion
Pharmacogenetics
positron emission tomography

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs