Diagosis of Breast Carcinoma: Characterization of Breast Lesions With CLEARPEMSONIC : Feasibility Study

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.

Study Overview

• Status: Terminated
• Conditions: Breast Carcinoma
• Intervention / Treatment: Device: MRI; Device: PET-CT scan; Device: PEM scan with ClearPemSonic

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breast cancer	Device: MRI; Device: PET-CT scan; Device: PEM scan with ClearPemSonic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MEASURE the Positron Emission Mammography (PEM)	the feasibility of PEM scan with the ClearPEmSonic	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MEASURE the other conventional imaging modalities and MRI.	to compare results with the different device	12 MONTHS

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: March 23, 2012
• First Submitted That Met QC Criteria: April 2, 2012
• First Posted (Estimate): April 3, 2012

Study Record Updates

• Last Update Posted (Estimate): April 21, 2015
• Last Update Submitted That Met QC Criteria: April 20, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Breast Diseases; Breast Neoplasms; Carcinoma
• Other Study ID Numbers: 2011-A01673-38; 2011-40 (Other Identifier: AP HM)