Clinical trial NCT06843096: Contrast Enhanced Mammography in the Evaluation of Cancer of Unknown Primary Syndrome
Official title: Contrast-Enhanced Mammography (CEM) in the Evaluation of Cancer of Unknown Primary Syndrome (CUP): A Multicentric Observational Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Breast Cancer Diagnosis
Breast Cancer Prevention
Keywords: Contrast-Enhanced Mammography (CEM)
Cancer of Unknown Primary (CUP)
Breast Cancer
MRI (Magnetic Resonance Imaging)
Diagnostic Imaging
Lead sponsor: Link Campus University
Sponsor class: OTHER
Collaborators: name: Link Campus University
name: University of Campania Luigi Vanvitelli
First posted: 2025-02-24
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of adult patients (aged 18 years and older) who are diagnosed with Cancer of Unknown Primary (CUP) syndrome and are suspected of having a primary breast malignancy based on clinical presentation or imaging findings. Eligible patients will have breast tissue suitable for Contrast-Enhanced Mammography (CEM) and will undergo CEM as part of their diagnostic workup to evaluate the potential primary tumor site.

The population will be diverse in terms of age, race, and ethnic backgrounds, provided they meet the inclusion criteria and do not fall under any of the exclusion criteria listed.

The study aims to include a cohort of patients with different stages of CUP syndrome to evaluate the effectiveness of CEM in identifying hidden primary tumors and its impact on clinical management and treatment decisions.

Brief summary: This study aims to evaluate the role of Contrast-Enhanced Mammography (CEM) in identifying the primary tumor site in patients presenting with Cancer of Unknown Primary (CUP) syndrome. By integrating functional and anatomical imaging, the study explores CEM's diagnostic value compared to standard imaging modalities in a single-center setting.

Detailed description: The study of CUP syndrome was conducted with MRI, but we propose the study with CEM

Eligibility criteria: Inclusion Criteria:

* Age: Patients aged 18 years or older.
* Diagnosis of CUP: Patients with a clinical diagnosis of Cancer of Unknown Primary (CUP) syndrome.
* Suspected Breast Malignancy: Patients with clinical or imaging suspicion of a primary breast malignancy.
* Informed Consent: Patients who are able to provide informed consent to participate in the study.
* Presence of Breast Tissue: Female or transgender patients with breast tissue eligible for Contrast-Enhanced Mammography (CEM).

Exclusion Criteria:

* Confirmed Primary Tumor: Patients with a confirmed primary tumor identified in an organ other than the breast.
* Contraindications to Contrast Agents: Patients with contraindications to the use of iodinated contrast agents (e.g., severe allergic reactions to contrast).
* Severe Renal Impairment: Patients with severe renal impairment (eGFR \< 30 mL/min/1.73 m²) who cannot safely receive contrast agents.
* Pregnancy or Breastfeeding: Pregnant or breastfeeding women, as contrast administration may be harmful to the fetus or neonate.
* Severe Medical Conditions: Patients with severe medical conditions that may compromise their participation or safety in the study.

Primary outcomes:
measure: Detection Rate of Primary Tumors using Contrast-Enhanced Mammography (CEM) in Patients with CUP Syndrome
timeFrame: From enrollment to the end of treatment at 12 months
Secondary outcomes:
measure: Sensitivity, Specificity, and Diagnostic Accuracy of CEM compared to Standard Imaging Modalities (Ultrasound, MRI, Mammography)
timeFrame: From enrollment to the end of treatment at 12 months
measure: Correlation of CEM Findings with Histopathological Results
timeFrame: From enrollment to the end of treatment at 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Link Campus University
Study officials:
affiliation: Link Campus University
name: Graziella Di Grezia, medicine and surgery
role: PRINCIPAL_INVESTIGATOR
References: