on-invasive breast cancer diagnosis by 18F-ethylcholine PET-MRI

Phase 1

Conditions: Patients with imaging suspected breast cancer (BI-RADS 4&5 on conventional imaging, e.g. mammography and ultrasound).
MedDRA version: 20.0Level: HLGTClassification code 10006291Term: Breast neoplasms malignant and unspecified (incl nipple)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0Level: HLGTClassification code 10006288Term: Breast neoplasms benign (incl nipple)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0Level: PTClassification code 10029815Term: Nuclear magnetic resonance imagingSystem Organ Class: 10022891 - Investigations
MedDRA version: 20.0Level: LLTClassification code 10036223Term: Positron emission tomographySystem Organ Class: 10022891 - Investigations
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: EUCTR2017-003089-29-AT

Lead Sponsor: Medical University of Vienna, Department of Biomedical Imaging and Image-guided Therapy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 100

Inclusion Criteria

• Breast lesion classified as suspicious on conventional imaging (ACR BI-RADS 4 or 5);
• Age > 18 years;
• No previous biopsy in the site of the lesion at the time of PET-MRI;
• Following histopathological confirmation of the lesion by biopsy or surgery.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

• Unstable or non-compliant patients;
• Pregnant or breast-feeding patients;
• Radiation therapy within the last six months or surgical interventions less than 12 weeks
before PET-MRI examination;
• Known contraindication to the intravenous administration of MR contrast agents or MRI
examination;
• Known contraindication to the intravenous administration of 18F-methylcholine; • Acute or chronic renal insufficiency;
• Pre- or post-transplant patients.