Clinical trial · Observational
Contrast Enhanced Mammography in the Evaluation of Cancer of Unknown Primary Syndrome
Contrast-Enhanced Mammography (CEM) in the Evaluation of Cancer of Unknown Primary Syndrome (CUP): A Multicentric Observational Study
NCT06843096CI-TRIAL-00086333CEM_CUP_syndrenrolling by invitationClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Diagnosis | — | UNRESOLVED | — |
| Breast Cancer Prevention | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast-Enhanced Mammography (CEM) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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
- description
- The primary outcome of this study is the detection rate of primary tumors in patients presenting with Cancer of Unknown Primary (CUP) syndrome using Contrast-Enhanced Mammography (CEM). The detection rate will be determined by comparing the CEM findings with histopathological results from biopsies or surgical specimens. This will allow us to assess the diagnostic accuracy of CEM in identifying occult primary tumors, particularly in the context of breast cancer.
Secondary outcomes (2)
- 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
- description
- This secondary outcome aims to evaluate the sensitivity, specificity, and diagnostic accuracy of CEM in detecting primary tumors compared to other conventional imaging techniques, including ultrasound, MRI, and standard mammography. These metrics will be analyzed to determine the relative effectiveness of CEM as a diagnostic tool.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.