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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01569321
• Other study ID #: 2011-A01673-38
• Secondary ID: 2011-40
• Status: Terminated
• Phase: N/A
• First received: March 23, 2012
• Last updated: April 20, 2015
• Start date: March 2012
• Est. completion date: March 2013

Study information

• Verified date: April 2015
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma

Intervention

Device:
• MRI

• PET-CT scan

• PEM scan with ClearPemSonic

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MEASURE the Positron Emission Mammography (PEM)	the feasibility of PEM scan with the ClearPEmSonic	12 months	No
Secondary	MEASURE the other conventional imaging modalities and MRI.	to compare results with the different device	12 MONTHS	No