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