Metformin in Breast Cancer, Visualized With Positron Emis... | NCT02882581

Studies
Metformin in Breast Cancer, Visualized With Positron Emission Tomography

NCT02882581

Sponsor

Aarhus University Hospital

Status

Completed

Last Update Posted

Jan 23, 2018Actual

Enrollment

7Actual

Phase

Phase 1

Conditions

Breast Cancer

Interventions

11C-metformin

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Jun 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

Aug 25, 2016

First Submission Date that Met QC Criteria

Aug 29, 2016

First Posted Date

Aug 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2018

Last Update Posted Date

Jan 23, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
11C-metformin	Experimental	All participants allocated to the study will be included in this arm	Radiation: 11C-metformin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
11C-metformin	Radiation	400MBq of 11C-metformin is injected in the cubital vein. The participant is then scanned for 120 min using Position Emission Tomography.	11C-metformin

Measure	Description	Time Frame
Metformin uptake in breast cancer		12 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Nuclear Medicine & PET-center, Aarhus University Hospital		Aarhus		DK-8000	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided