Metformin in Breast Cancer, Visualized With Positron Emission Tomography

Breast Cancer Clinical Trial

Official title:

Metformin in Breast Cancer, Visualized With Positron Emission Tomography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02882581
• Other study ID #: 2016-000132-18
• Status: Completed
• Phase: Phase 1
• First received: August 25, 2016
• Last updated: January 19, 2018
• Start date: August 2016
• Est. completion date: October 2017

Study information

• Verified date: January 2018
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: October 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of Nuclear Medicine & PET-center, Aarhus University Hospital	Aarhus
Denmark	Department of Surgery, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metformin uptake in breast cancer		12 months