Detection Rate and Classification of Breast Lesions with Digital Mammography with Contrast Medium (Cedm) Alone and in Combination with Tomosynthesis Compared to MR Imaging with Gadolinium in Dynamics (Dce-Mri) - Cedm-Mri

Overview

Sponsor-declared trial summary

Key facts

Sponsor

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-01-08

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-519017-62-00

EudraCT number

2019-003699-38

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Safety, Efficacy

Evaluate, on a large case series, the detection rate and diagnostic accuracy, as well as the extent of breast pathology in terms of multifocality, multicentricity, and bilaterality, of CEDM alone and in combination with tomosynthesis, compared to MRI, considered both as CE-MRI and DCE-MRI.

Secondary objectives 1

1. The evaluation of a radiomic signature of morphological and textural features extracted from three imaging techniques (CEDM, DBT, and MRI) in the classification of breast lesions in terms of benignity, malignancy, grade, and tumor phenotype

Conditions and MedDRA coding

breast pathology

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age > 18 years
2. Patients with suspected breast pathology or patients in pre-surgical staging for breast pathology already confirmed by conventional imaging (Ultrasound and/or traditional 2D Mammography) or by cytological/histopathological examination
3. Full information about the study and signing of the informed consent to participate in the study
4. Performance of exams at any time during the menstrual cycle
5. Estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73 m², derived from serum creatinine measurement within two weeks prior to enrollment in the study

Exclusion criteria 24

1. Presence of pacemakers or other devices in the chest wall
2. Inability to remain still during the examination
3. Inflammatory dermatological diseases (psoriasis, eczema, etc.)
4. Presence of tattoos in the affected area
5. Presence of nipple piercings that cannot be removed
6. Internal/external devices that prevent proper patient positioning
7. Metallic/electronic implants, metal fragments
8. Specific breast morphology that hinders the examination (particularly overly large breasts)
9. Allergies to metals
10. Allergies to iodinated contrast media and/or gadolinium
11. Claustrophobia
12. Acute renal failure of any severity due to hepatorenal syndrome and/or established in the preoperative period of liver transplantation
13. Acute or chronic renal failure, moderate or severe (glomerular filtration rate <60 mL/min/1.73m²)
14. Hypersensitivity to the active ingredient of the contrast medium or any of its excipients
15. Overt thyrotoxicosis
16. Participation in a clinical trial where an investigational drug was administered within 30 days or 5 half-lives of the study drug
17. Any clinical condition that, in the investigator's opinion, would render the patient unsuitable for the study
18. Presence of breast implants
19. Pregnancy or breastfeeding
20. Presence of severe heart disease and pulmonary hypertension
21. Presence of acute brain disorders, history of epilepsy
22. Presence of paraproteinemia (myelomatosis and Waldenström's macroglobulinemia)
23. Presence of pheochromocytoma
24. Presence of hyperthyroidism

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Equivalence/Comparability of CEDM alone and in combination with DBT compared to Contrast-Enhanced MRI (CE-MRI) in terms of detection rate and diagnostic accuracy.

Secondary endpoints 1

1. Evaluation of the diagnostic accuracy of a radiomic signature of morphological and textural features extracted from the three modalities (CEDM, DBT, and MRI) in the classification of breast lesions in terms of benignity, malignancy, grade, and tumor phenotype (luminal A, luminal B, HER2+, triple negative).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Sponsor organisation

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Address

Via Mariano Semmola 52

City

Naples

Postcode

80131

Country

Italy

Scientific contact point

Organisation

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Contact name

Antonella Petrillo

Public contact point

Organisation

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Contact name

Antonella Petrillo

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications