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

Measuring hallmarks of cancer for non-invasive characterization of breast lesions by simultaneous multiparametric 18F-ethylcholine PET- MRI – an exploratory study - Measuring hallmarks of cancer for non-invasive breast cancer diagnosis by 18F-ethylcholine PET-MRI

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003089-29-AT

Enrollment

100

Registered

2017-10-27

Start date

2018-04-06

Completion date

Unknown

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with imaging suspected breast cancer (BI-RADS 4&5 on conventional imaging, e.g. mammography and ultrasound). MedDRA version: 20.0 Level: HLGT Classification code 10006291 Term: Breast neoplasms malignant and unspecified (incl nipple) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: HLGT Classification code 10006288 Term: Breast neoplasms benign (incl nipple) System Organ Class: 10029104 - Neoplasms benign, m

Interventions

Trade Name: FEC-MAX Product Name: (18F) Fluorethylcholine Pharmaceutical Form: Injection INN or Proposed INN: 18F-FCH CAS Number: 44580-38-3 Other descriptive name: FLUOROCHOLINE (18F) CHLORIDE Concen

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Diagnostic performance indices for distinguishing benign from malignant tissues (Area Under the Receiver Operating Characteristics Curve - AUC, Sensitivity, Specificity) calculated in a patient-, region- and lesion-wise manner. All diagnostic performance indices will be calculated for single and combined parameters.;Timepoint(s) of evaluation of this end point: Each diagnostic test will be immediately classified as "positive" or "negative". After the reference standard (biopsy or open surgery with subsequent histopathological evaluation) is present, true positives (test positive, reference standard positive), false positives (test positive, reference standard negative), false negatives (test negative, reference standard positive) and true negatives (test negative, reference standard negative) will be assigned.;Main Objective: To investigate whether multi-parametric simultaneous PET-MRI with 18F-methylcholine will improve the detection and characterization of mammographically and sonographically suspicious breast lesions.;Secondary Objective: To investigate whether multi-parametric simultaneous PET-MRI with 18F-methylcholine will improve the diagnosis of disease extent in patients with breast cancer.	—

Measure

Time frame

Primary end point(s): Diagnostic performance indices for distinguishing benign from malignant tissues (Area Under the Receiver Operating Characteristics Curve - AUC, Sensitivity, Specificity) calculated in a patient-, region- and lesion-wise manner. All diagnostic performance indices will be calculated for single and combined parameters.;Timepoint(s) of evaluation of this end point: Each diagnostic test will be immediately classified as "positive" or "negative". After the reference standard (biopsy or open surgery with subsequent histopathological evaluation) is present, true positives (test positive, reference standard positive), false positives (test positive, reference standard negative), false negatives (test negative, reference standard positive) and true negatives (test negative, reference standard negative) will be assigned.;Main Objective: To investigate whether multi-parametric simultaneous PET-MRI with 18F-methylcholine will improve the detection and characterization of mammographically and sonographically suspicious breast lesions.;Secondary Objective: To investigate whether multi-parametric simultaneous PET-MRI with 18F-methylcholine will improve the diagnosis of disease extent in patients with breast cancer.

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Secondary

Measure	Time frame
Secondary end point(s): Diagnostic performance indices (as defined above) for correct versus incorrect staging (estimation of disease extent).;Timepoint(s) of evaluation of this end point: Same as for primary endpoint.	—

Countries

Austria

Contacts

Public ContactMolecular and Gender Imaging

Medical University of Vienna

pascal.baltzer@meduniwien.ac.at+4314040048180

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: May 22, 2026