NCT02882581

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1 breast-cancer

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_1 breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

10 months

First QC Date

August 25, 2016

Last Update Submit

January 19, 2018

Conditions

Breast Cancer

Keywords

MetforminPharmacokineticsOrganic cation transporterMultidrug and toxin extrusionPharmacogeneticspositron emission tomography

Outcome Measures

Primary Outcomes (1)

  • Metformin uptake in breast cancer

    12 months

Study Arms (1)

11C-metformin

EXPERIMENTAL

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

Radiation: 11C-metformin

Interventions

11C-metforminRADIATION

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

11C-metformin

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Aarhus, DK-8000, Denmark

Location

Department of Surgery, Aarhus University Hospital

Aarhus, DK-8000, Denmark

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Niels Jessen, Prof,MD,PhD

    Department of Clinical Pharmacology, Aarhus University Hospital

    STUDY DIRECTOR

  • Elias IO Sundelin, MD

    Department of Clinical Medicine, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 11C-metformin uptake in breast cancer. Single center, single dose, open-label.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 25, 2016

First Posted

August 30, 2016

Study Start

August 1, 2016

Primary Completion

June 1, 2017

Study Completion

October 1, 2017

Last Updated

January 23, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)