18F-Fluorometilcholine (18F-FCH) PET/CT sensibility in diagnosing breast cancer metastasis

• Conditions: de novo breast cancer metastasis; MedDRA version: 14.0Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-003036-31-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-14
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

-female gender subjects only -previous primary breast cancer, radically treated to complete clinical remission, to clinician’s judgement -availability of clinical and pathologic documentation of primary disease, to be considered satisfactory to investigator’s judment (generally comprising histological diagnosis, assessment of ER, PgR, Erb-B2 status, pathologicl staging at diagnosis, plasma levels of CEA and 15.3, etc) -subjects must have been enrolled in routinary clinical follow-up schedule in oncologic centres -chemotherapy and/or radiotherapy ceased for at least 6 months -hormonal therapy allowed, to be suspended for 10 days after enrollment, till PET/CT examination -estabilished recent diagnosis of previously unrecognized metastatic disease diagnosis of metastatic disease should be estabilished on the basis of radiological evidence; full documentation of restaging need to be avalaible. Histological confirmation is preferred, but is not obligatory. Biopsy should be not more recent than 30 days. Some kinds of radiological examinations are to be considered obligatory (bone scan, whole body CT, MRI utilized for osseous lesions referred as suspect in bone scans for vertebrae, skull, pelvic bones, long bones).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

-pregnancy -chemotherapy or radiotherapy administration in previous 6 months -presence of different oncologic disease, including leukemia, lymphoma, plasma cell disease -presence of chronic liver disease, including chronic hepatitis ans cirrhosis -Karnofsky performance status <80% -actual or previous enrollment in different clinical trials with administration of ionizing radiation -ionizing radiation exposure due to work or profession -recent surgery or biopsies (<30 days) -inability to understand or subscribe an informed consent to participate to clinical trials, including being minor.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: evaluation of 18F-FCH PET/CT for diagnosis of de novo breast cancer metastasis;Secondary Objective: optimization of post iniective PET/CT scanning time;Primary end point(s): none;Timepoint(s) of evaluation of this end point: none

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none