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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

MEASURE the Positron Emission Mammography (PEM)

Outcome Description:

the feasibility of PEM scan with the ClearPEmSonic

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

BERNARD BELAIGUES

Investigator Role:

Study Director

Investigator Affiliation:

Assistance Publique hôpitaux de Marseille

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2011-A01673-38

NCT ID:

NCT01569321

Start Date:

March 2012

Completion Date:

September 2013

Related Keywords:

  • Breast Carcinoma
  • Breast Neoplasms
  • Carcinoma

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