CLASSIFICATION OF BREAST LESIONS WITH DIGITAL MAMMOGRAPHY WITH CONTRAST MEDIUM (CEDM)

Phase 1

• Conditions: Breast souspicious lesions; MedDRA version: 21.1Level: LLTClassification code 10066275Term: Comedocarcinoma of breastSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-003699-38-IT
• Lead Sponsor: ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 358

Inclusion Criteria

a)age> 18 years
b)patients with suspected mammary pathology or patients in pre-surgical staging due to already ascertained breast pathology (conventional ultrasound and / or traditional 2D mammography) or with a cito / pathological examination
c)full information on the study and signature of the informed consent to participate in the study
d)execution of examinations at any time of the menstrual cycle
e)estimated glomerular filtrate rate (eGFR)> 60mL / min / 1.73m2, derived from serum creatinine dosage within two weeks prior to study enrollment
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 358
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

Absolute exclusion criteria
a) presence of pacemakers or other devices in the chest wall
b) inability to maintain an immobile position during the examination
c) inflammatory dermatological diseases (psoriasis, eczema, etc.)
d) presence of tattoos on the affected area
e) presence of nipple piercings that cannot be removed
f) internal / external devices that prevent correct patient positioning
g) metal / electronic systems, metal splinters
h) particular conformation of the breast which prevents the examination from being carried out (in particular breast too large)
i) metal allergies
j) allergies to iodine and / or gadolinium contrast medium
k) claustrophobia
l) acute renal failure of any severity due to hepatorenal syndrome and / or established in the pre-operative period after liver transplantation
m) acute or chronic, moderate or severe renal failure (glomerular filtration rate <60mL / min / 1.73m2)
n) hypersensitivity to the active ingredient of the contrast medium or to any of the excipients (see brochure Visipaque 320)
o) Full-blown thyrotoxicosis
p) participation in a clinical study in which an experimental drug was administered within 30 days or 5 half-lives of the study drug
q) any clinical condition that in the investigator's judgment would make the patient unsuitable for the study
r) presence of breast implants
s) pregnancy or breastfeeding **
t) presence of severe heart disease and pulmonary hypertension
u) presence of acute brain pathologies, history of epilepsy
v) presence of paraproteinemia (myelomatosis and Waldenström macroglobulinemia)
w) presence of pheochromocytoma
x) presence of hyperthyroidism.
** The state of pregnancy was first ascertained from enrollment by means of the dosage of Beta-hCG on the urine (pregnancy test or urinary beta-HCG) or on the blood (plasma beta-hCG).

Relative exclusion criteria
a) targeted micro-biopsy in the ipsilateral breast within three months from the date of enrollment in the study
b) needle drawn into the ipsilateral breast within one month of the study enrollment date
c) presence of surgical clips or open wounds

Study & Design

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