NCT01569321

Brief Summary

Breast cancer is the first cancer in women, the second etiology of death by cancer and the first cause for women between 35 and 55 years. Diagnostic tools and large screening have been realized with positive impact in a recent review with 31% less likely to die of breast cancer over nearly 30 years compared to women who didn't get regular screening mammograms. Diagnostic tools and treatment also are improving continuously. However, for some women, breast cancer diagnosis is difficult, in case of high density breast, breast modifications after surgery… In these cases, breast MRI is currently the best imaging tool, with high sensitivity about 90% but with a lower specificity about 60%, that lead to futile biopsies. Recently, molecular imaging with PET-CT scan with 18FDG has permitted to widely modify cancer treatment. However, PET-CT scan is not a good imaging tool for initial diagnostic of breast tumor because of a lack in spatial resolution about 8mm. So, researchers developed dedicated PET scan for breast, called Positron Emission Mammography. Our project is in this field of view and is named CLEARPEMSONIC. First clinical studies with PEM showed very good performance of this imaging modality for initial evaluation of breast tumors. PEM performance is not affected by breast density, hormonal status. Spatial resolution is less than 3mm. PEM seems complementary with MRI, adding a better specificity value. In the field of CERIMED, ClearPemSonic Project aims to evaluate an new imaging tool which combined PEM scan and ultrasonography. Technologic evaluation was made. Now a feasibility study is the first step for clinical applications. The main objective of this project is to confirm the feasibility of PEM scan with the ClearPEmSonic. Secondary objectives are to compare results with other conventional imaging modalities and MRI. The gold standard will be histology of the breast tumor.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 3, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

1 year

First QC Date

March 23, 2012

Last Update Submit

April 20, 2015

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

  • MEASURE the Positron Emission Mammography (PEM)

    the feasibility of PEM scan with the ClearPEmSonic

    12 months

Secondary Outcomes (1)

  • MEASURE the other conventional imaging modalities and MRI.

    12 MONTHS

Study Arms (1)

Breast cancer

EXPERIMENTAL
Device: MRIDevice: PET-CT scanDevice: PEM scan with ClearPemSonic

Interventions

MRIDEVICE
Breast cancer
PET-CT scanDEVICE
Breast cancer
PEM scan with ClearPemSonicDEVICE
Breast cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Mammary Néoplasia ready(in position) (diagnosed on histological taking of type(chap) biopsy)
  • Waits whose realization of an imaging TEP-TDM in the 18FDG is required for the coverage(care) of a mammary néoplasia. The decision of realization of this TEP-TDM can be validated during a RCP.

You may not qualify if:

  • Other cancerous affection;
  • Pregnant Woman. Nursing mother
  • Patient presenting difficulties of follow-up (insufficient motivation, imminent transfer(transformation) in a city where the study cannot be led)
  • Patient incapable to give their written consent.
  • Patient claustrophobic or presenting a contraindication to the realization of the MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • BERNARD BELAIGUES

    Assistance Publique hôpitaux de Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2012

First Posted

April 3, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations

FR(1)